29 Clinical Operations jobs in Malaysia

About ThoughtFull:

ThoughtFull is a Temasek-backed digital mental health company that provides seamless end-to-end mental healthcare for all through insurers and employee benefits. Through our app, ThoughtFullChat (“TFC”), individuals are empowered to proactively engage with their mental wellbeing to better themselves regardless of where their starting point is – from self-driven learning, to our proprietary one-on-one daily bite-sized coaching with mental health professionals on text, video, or in-person – we run the gamut and meet our users where they are most comfortable. After all, healthy employees make for more engaging and productive work environments.

Our vision is to make mental health a priority for everyone, every day. It’s an audacious dream, but with the right people who are courageous enough to Dream Audaciously, Do ThoughtFully, we believe that this dream can be our future reality. If you are committed to doing the best work of your lives to be the change that you want to see in this world, join us!

Job Description:

We are seeking a Clinical Operations Manager to support and scale our mental health service delivery across multiple countries. This role oversees the operational execution of ThoughtFull’s clinical programs, ensuring that our network of ThoughtFull Professionals (TFPs) is effectively onboarded, supported, and guided by the highest standards of clinical care. You’ll collaborate across clinical, product, and client success teams to deliver seamless client experiences while driving operational efficiency, compliance, and quality.

What you will do:

1. Clinical Network Operations

• Manage onboarding, credentialing, scheduling, and operational support for TFPs across multiple geographies.

• Monitor key service delivery metrics including utilization, timeliness, and provider engagement.

• Liaise with TFPs and clients to resolve operational issues and ensure timely management and escalation as needed.

2. Quality Control and Clinical Governance

• Work with the clinical development specialist (Clinical Psychologist) to implement and monitor quality assurance frameworks, including documentation audits, session compliance, and client feedback review.

• Work with the Clinical Development Specialist to implement continuous professional development initiatives for TFPs, including townhalls, peer learning forums, and training.

• Work closely with the Head of Clinical Research and Development and Head of Product to maintain ethical and clinical standards across all modalities.

3. Service Delivery Coordination

• Support the rollout and scaling of onsite and online therapy services, assessments, group programs, and customized wellbeing initiatives.

• Track service utilization, provider capacity, and service impact to inform resource planning and client reporting.

• Coordinate between clinical, product, and client success teams to ensure seamless client experience.

4. Compliance and Risk Management

• Maintain up-to-date documentation, licensure, and credentialing of TFPs in accordance with country-specific and regional regulations.

• Ensure clinical policies and procedures are compliant with applicable legal, ethical, and professional standards in each operational country.

• Support incident reporting and resolution protocols when required.

5. Operational Process Improvement

• Identify bottlenecks and propose data-driven process improvements to enhance efficiency and clinician experience.

• Implement tools and workflows that support operational scaling and automation.

• Contribute to building sustainable systems that support regional expansion and evolving service offerings.

About You:

Required :

• Bachelor’s degree in behavioral sciences, public health, healthcare management, or a related field.
• 5–7 years’ experience in clinical operations, healthcare service delivery, or digital health.
• Familiarity with mental health service delivery, clinician networks, and quality assurance frameworks.
• Strong project management and cross-functional coordination skills.
• Comfortable with digital tools, including telehealth platforms and clinician management systems
• Thrive in fast-paced, multicultural startup environments

Preferred:

• Master’s degree in public health, healthcare administration or related fields
• Experience in digital health platforms or employee wellbeing programs.
• Knowledge of regulatory environments in Southeast Asia.

Thoughtfull is an equal opportunity employer. We provide equal employment opportunities regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. If you have a disability or special need, please inform us for accommodation.

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About ThoughtFull: ThoughtFull is a Temasek-backed digital mental health company that provides seamless end-to-end mental healthcare for all through insurers and employee benefits. Through our app, ThoughtFullChat (“TFC”), individuals are empowered to proactively engage with their mental wellbeing to better themselves regardless of where their starting point is – from self-driven learning, to our proprietary one-on-one daily bite-sized coaching with mental health professionals on text, video, or in-person – we run the gamut and meet our users where they are most comfortable. After all, healthy employees make for more engaging and productive work environments. Our vision is to make mental health a priority for everyone, every day. It’s an audacious dream, but with the right people who are courageous enough to

Dream Audaciously, Do ThoughtFully,

we believe that this dream can be our future reality. If you are committed to doing the best work of your lives to be the change that you want to see in this world, join us! Job Description: We are seeking a Clinical Operations Manager to support and scale our mental health service delivery across multiple countries. This role oversees the operational execution of ThoughtFull’s clinical programs, ensuring that our network of ThoughtFull Professionals (TFPs) is effectively onboarded, supported, and guided by the highest standards of clinical care. You’ll collaborate across clinical, product, and client success teams to deliver seamless client experiences while driving operational efficiency, compliance, and quality. What you will do: 1. Clinical Network Operations Manage onboarding, credentialing, scheduling, and operational support for TFPs across multiple geographies. Monitor key service delivery metrics including utilization, timeliness, and provider engagement. Liaise with TFPs and clients to resolve operational issues and ensure timely management and escalation as needed. 2. Quality Control and Clinical Governance Work with the clinical development specialist (Clinical Psychologist) to implement and monitor quality assurance frameworks, including documentation audits, session compliance, and client feedback review. Work with the Clinical Development Specialist to implement continuous professional development initiatives for TFPs, including townhalls, peer learning forums, and training. Work closely with the Head of Clinical Research and Development and Head of Product to maintain ethical and clinical standards across all modalities. 3. Service Delivery Coordination Support the rollout and scaling of onsite and online therapy services, assessments, group programs, and customized wellbeing initiatives. Track service utilization, provider capacity, and service impact to inform resource planning and client reporting. Coordinate between clinical, product, and client success teams to ensure seamless client experience. 4. Compliance and Risk Management Maintain up-to-date documentation, licensure, and credentialing of TFPs in accordance with country-specific and regional regulations. Ensure clinical policies and procedures are compliant with applicable legal, ethical, and professional standards in each operational country. Support incident reporting and resolution protocols when required. 5. Operational Process Improvement Identify bottlenecks and propose data-driven process improvements to enhance efficiency and clinician experience. Implement tools and workflows that support operational scaling and automation. Contribute to building sustainable systems that support regional expansion and evolving service offerings. About You: Required : Bachelor’s degree in behavioral sciences, public health, healthcare management, or a related field. 5–7 years’ experience in clinical operations, healthcare service delivery, or digital health. Familiarity with mental health service delivery, clinician networks, and quality assurance frameworks. Strong project management and cross-functional coordination skills. Comfortable with digital tools, including telehealth platforms and clinician management systems Thrive in fast-paced, multicultural startup environments Preferred: Master’s degree in public health, healthcare administration or related fields Experience in digital health platforms or employee wellbeing programs. Knowledge of regulatory environments in Southeast Asia. Thoughtfull is an equal opportunity employer. We provide equal employment opportunities regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. If you have a disability or special need, please inform us for accommodation.

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This job involves joining a growing company specializing in prosthetics and orthotics. The successful candidate will ensure compliance with medical regulations and support daily operational activities. You might find this role appealing if you enjoy streamlining processes and maintaining quality standards.

We are a Malaysia-based prosthetics and orthotics company dedicated to delivering high-quality assistive solutions. We are seeking a proactive and detail-oriented Compliance & Operations Executive to join our team. This dual-role position will be responsible for ensuring adherence to Medical Device Authority (MDA) regulations and supporting operational efficiency to improve workflow, productivity, and service delivery.

Regulatory Compliance

• Manage MDA registration, licensing, and renewal processes (establishment license, product registration, etc.).
• Prepare, submit, and maintain documentation for MDA and other regulatory bodies.
• Act as the primary liaison with MDA, ensuring compliance with Medical Device Act 2012 (Act 737).
• Monitor and communicate regulatory updates to internal teams and systems.
• Assist with product traceability, adverse event reporting, and post-market surveillance activities.

Operations & Workflow Management

• Track project timelines, client orders, and job progress using internal tools or spreadsheets.
• Identify inefficiencies and implement process improvements.
• Coordinate among clinical, technical, and administrative teams to ensure timely service delivery.
• Support inventory management, scheduling, and procurement as needed.
• Generate reports on operations, compliance, and performance metrics periodically.

Administrative & Support Duties

• Assist in developing SOPs related to compliance and operations.
• Maintain documentation for audits, reviews, and certifications like ISO.
• Support the team with ad hoc operational or regulatory tasks.

Job Requirements

• Degree or diploma in Healthcare Management, Business Administration, or related fields.
• Experience or strong understanding of MDA regulatory processes is highly preferred.
• Experience in operations, compliance, or administrative roles within the healthcare industry is a plus.
• Excellent organizational and communication skills.
• Proficiency in Microsoft Office, especially Excel.
• Ability to work independently and manage multiple responsibilities.

Skills

• Operations
• Regulatory Compliance

Company Benefits

• Sick, hospitalization, maternity, and paternity leaves, with increases based on years of service.
• Mileage claims, overtime pay per labor laws, and medical claims from approved institutions.
• Attractive travel allowances.

Established in 1994, Limb Brace has been providing patient-oriented prosthetic and orthotic services across Malaysia and internationally. Our mission is to deliver the best patient care in the industry.

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Clinical Research Associate (CRA), Clinical Trials Unit

To assist the Clinical Trials Manager (CTM) in management of the clinical trial portfolios and operations in line with the CRMY’s strategy for the Clinical/Translational Research Programmes (the “Programme”).

Responsibilities:

Clinical Trial Operations:

Ensure all activities/tasks delegated are completed and meeting the defined objectives within the specified timeframe and resources

Working under the supervision of the CTM to:

• Develop clinical trials documentation and toolkits for CRMY sponsored Trials and Investigator Initiated Trials
• Plan and manage clinical trials conceived internally or externally
• Support the CTM in conducting study feasibility for new clinical trials

Study Monitoring:

• Coordinate with the respective clinical trial teams to organize periodical study monitoring visit (on-site or remotely) in ensuring trials are conducted in compliance to study protocol, GCP, ICH guidelines, ethics and regulatory requirements
• Advise clinical trial teams on matters pertaining to GCP compliance and propose resolutions to findings/issues identified during study monitoring visit
• Deliver monitoring report after each study monitoring visit

Data Management:

• Assist CTM in designing the eCRF and perform test on the EDC prior migration to production mode
• Assist CTM in drafting the CRF Completion Guideline and Data Monitoring Guide for new trials

Sample Management:

• Coordinate sample management for IITs including ensuring the sufficient supply of study materials to be provided to Site and updating Site on changes on the protocol relating to sample collection/processing
• Coordinate the shipment of biospecimen from Sites to CRMY lab
• Ensure all biospecimen are stored or archived as specified in study protocol

Escalate critical issues pertaining to Study and Site Management to CTM

Compliance and Quality Management:

• Work together with CTM and research teams to develop and refine Standard Operational Procedure (SOP) for clinical trial operations
• Provide consultation to study teams on the compliance to SOPs
• File and maintain GCP certificates of CRMY employee who are involved in Clinical Trial activities and provide information to CRMY staff on the latest GCP workshops in Malaysia

Other responsibilities include:

• To represent the team and Cancer Research Malaysia when appropriate
• To undertake other administrative tasks as required

Requirement:

• Educated to degree level (Life Science or related fields), with minimal 1-year clinical research or clinical monitoring experience
• Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and local IRB/EC requirements
• Experience with study management SOPs
• Experience with EDC system such as REDCap and basic knowledge on data management
• Ability to establish links between various elements necessary to the proper conduct of the clinical study
• Meticulous, detailed, well-organized and able to work independently to meet datelines
• Excellent communication and interpersonal skills

We are an independent and non-profit cancer research organisation based in Malaysia. Funded by donations and research grants, we conduct research in niche cancers often found in our Asian population.

Cancer — the big ‘C’ — continues to be a stigma, only spoken about in hushed whispers; how it’s bad karma, how much it costs, and that nothing could be done.

Confronting this stigma head on, CRM has been reversing this language of cancer, transforming the big ‘C’ to a little ‘c’, and we plan to develop tools backed by good research to ensure that we can truly fight cancer on all fronts.

We believe that we will reverse the grip of cancer in our lives. We want researchers to win the war against cancer by turning it around with new ways of prevention and cure. We want to empower the public through impactful outreach programmes, with the hopes that Malaysians will respond differently to cancer by coming forward for screenings and going through with treatments.

Our driving force is held together by these goals:

• Improving the survival rates of Asian cancer patients, focusing on neglected areas of research.
• Empowering Asians to have the proper screening and treatment.
• Improving survival rates by being more accessible, focusing on providing existing cures to patients rather than sit on inaction and potentially losing lives.
• Making affordable and timely treatments by repurposing drugs, acknowledging the reality that developing new cures are costly and risky.
• Putting Malaysia in the global spotlight for cancer research by collaborating with top scientists around the world,and working to nurture the next generation of Malaysian cancer researchers.

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Clinical Research Associate (CRA), Clinical Trials Unit

To assist the Clinical Trials Manager (CTM) in management of the clinical trial portfolios and operations in line with the CRMY’s strategy for the Clinical/Translational Research Programmes (the “Programme”). Responsibilities: Clinical Trial Operations: Ensure all activities/tasks delegated are completed and meeting the defined objectives within the specified timeframe and resources Working under the supervision of the CTM to: Develop clinical trials documentation and toolkits for CRMY sponsored Trials and Investigator Initiated Trials Plan and manage clinical trials conceived internally or externally Support the CTM in conducting study feasibility for new clinical trials Study Monitoring: Coordinate with the respective clinical trial teams to organize periodical study monitoring visit (on-site or remotely) in ensuring trials are conducted in compliance to study protocol, GCP, ICH guidelines, ethics and regulatory requirements Advise clinical trial teams on matters pertaining to GCP compliance and propose resolutions to findings/issues identified during study monitoring visit Deliver monitoring report after each study monitoring visit Data Management: Assist CTM in designing the eCRF and perform test on the EDC prior migration to production mode Assist CTM in drafting the CRF Completion Guideline and Data Monitoring Guide for new trials Sample Management: Coordinate sample management for IITs including ensuring the sufficient supply of study materials to be provided to Site and updating Site on changes on the protocol relating to sample collection/processing Coordinate the shipment of biospecimen from Sites to CRMY lab Ensure all biospecimen are stored or archived as specified in study protocol Escalate critical issues pertaining to Study and Site Management to CTM Compliance and Quality Management: Work together with CTM and research teams to develop and refine Standard Operational Procedure (SOP) for clinical trial operations Provide consultation to study teams on the compliance to SOPs File and maintain GCP certificates of CRMY employee who are involved in Clinical Trial activities and provide information to CRMY staff on the latest GCP workshops in Malaysia Other responsibilities include: To represent the team and Cancer Research Malaysia when appropriate To undertake other administrative tasks as required Requirement: Educated to degree level (Life Science or related fields), with minimal 1-year clinical research or clinical monitoring experience Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and local IRB/EC requirements Experience with study management SOPs Experience with EDC system such as REDCap and basic knowledge on data management Ability to establish links between various elements necessary to the proper conduct of the clinical study Meticulous, detailed, well-organized and able to work independently to meet datelines Excellent communication and interpersonal skills We are an independent and non-profit cancer research organisation based in Malaysia. Funded by donations and research grants, we conduct research in niche cancers often found in our Asian population. Cancer — the big ‘C’ — continues to be a stigma, only spoken about in hushed whispers; how it’s bad karma, how much it costs, and that nothing could be done. Confronting this stigma head on, CRM has been reversing this language of cancer, transforming the big ‘C’ to a little ‘c’, and we plan to develop tools backed by good research to ensure that we can truly fight cancer on all fronts. We believe that we will reverse the grip of cancer in our lives. We want researchers to win the war against cancer by turning it around with new ways of prevention and cure. We want to empower the public through impactful outreach programmes, with the hopes that Malaysians will respond differently to cancer by coming forward for screenings and going through with treatments. Our driving force is held together by these goals: Improving the survival rates of Asian cancer patients, focusing on neglected areas of research. Empowering Asians to have the proper screening and treatment. Improving survival rates by being more accessible, focusing on providing existing cures to patients rather than sit on inaction and potentially losing lives. Making affordable and timely treatments by repurposing drugs, acknowledging the reality that developing new cures are costly and risky. Putting Malaysia in the global spotlight for cancer research by collaborating with top scientists around the world,and working to nurture the next generation of Malaysian cancer researchers.

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Job Description

Clinical Research Associate (CRA)

• Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR Asia
• We were awarded ‘Sponsor of the Year’ in 2019, 2020, 2022 and 2024 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the country!
• We have a proud legacy of turning breakthrough science into medicines and vaccines that save and improve lives around the world. We are focused on discovering new solutions for today and the future!
• Join the premier biopharmaceutical company that has been in the business for more than 125 years

The role is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.

Responsibilities include, but are not limited to:

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure:
o Data generated at site are complete, accurate and unbiased.
o Subjects’ right, safety and well-being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
• Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
• Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.

Extent of Travel:

• Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling 2-3 days/week.
• Current driver’s license preferred (Must have in certain countries).

Qualifications, Skills & Experience
CORE Competency Expectations:

• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices.
• Proven Skills in Site Management including management of site performance and patient recruitment.
• Demonstrated high level of monitoring skill with independent professional judgment.
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
• Ability to understand and analyse data/metrics and act appropriately.
• Capable of managing complex issues, works in a solution-oriented manner.
• Performs root cause analysis and implements preventative and corrective action.

Behavioural Competency Expectations:

• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
• Able to work highly independently across multiple protocols, sites and therapy areas.
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus.
• Works with high quality and compliance mind-set.
• Positive mindset, growth mindset, capable of working independently and being self-driven.
• Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

Experience Requirements:
Required:
• Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements:
Preferred:
• B.A./B.S. with strong emphasis in science and/or biology.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Accountability, Accountability, Adaptability, Adverse Event Reporting System, Biopharmaceutical Industry, Biopharmaceuticals, Clinical Medicine, Clinical Research Methods, Clinical Sciences, Clinical Site Management, Clinical Study Management, Clinical Testing, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Reporting, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Healthcare Innovation, Management Process, Medical Research, Monitoring Control, Organizational Performance Management, Problem Solving, Protocol Adherence {+ 4 more}

Preferred Skills:

Job Posting End Date:

07/15/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R353235

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Tigermed Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Clinical Research Associate

Tigermed Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

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1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations.

1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

2.Responsibilities

(a) Site management

•Study site selection, initiation (SIV) and clinical monitoring.

•Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.

•Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.

•Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.

•Track study recruitment to ensure recruitment target is achieved in all studies.

•Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.

•Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.

•Assemble site specific EC submission dossier, and ensure submission to EC.

Training

•Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.

•Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.

Documentation

•Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.

•Prepare/complete study records’ archiving according to protocol and sponsor requirements.

(b) Drug Safety

•Ensure safety information is disseminated to all sites according SOP and applicable regulations.

•Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.

(c) Finance and Administration

•Finalize budget and obtain signed contract from site, prior to site initiation visit.

•Ensure Study Payment Schedule is executed and retain relevant documents/receipts.

(d) Study Tools and system

•Update and maintain Study tools/systems in a timely manner.

3. Qualifications

3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements;

3.2 At least 1 year of CRA experience;

3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;

3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Seniority level

• Seniority level Associate

Employment type

• Employment type Full-time

Job function

• Job function Research
• Industries Pharmaceutical Manufacturing

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Clinical Research Associate page is loadedClinical Research Associate Apply remote type Hybrid locations MYS - Selangor - Petaling Jaya (Ascent Paradigm) time type Full time posted on Posted 2 Days Ago time left to apply End Date: August 16, 2025 (4 days left to apply) job requisition id R353235

Job Description

Clinical Research Associate (CRA)

• Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR Asia
• We were awarded ‘Sponsor of the Year’ in 2019, 2020, 2022 and 2024 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the country!
• We have a proud legacy of turning breakthrough science into medicines and vaccines that save and improve lives around the world. We are focused on discovering new solutions for today and the future!
• Join the premier biopharmaceutical company that has been in the business for more than 125 years

The role is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.

Responsibilities include, but are not limited to:

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure:
o Data generated at site are complete, accurate and unbiased.
o Subjects’ right, safety and well-being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
• Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
• Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.

Extent of Travel:

• Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.
• Current driver’s license preferred (Must have in certain countries).

Qualifications, Skills & Experience
CORE Competency Expectations:

• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices.
• Proven Skills in Site Management including management of site performance and patient recruitment.
• Demonstrated high level of monitoring skill with independent professional judgment.
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
• Ability to understand and analyse data/metrics and act appropriately.
• Capable of managing complex issues, works in a solution-oriented manner.
• Performs root cause analysis and implements preventative and corrective action.

Behavioural Competency Expectations:

• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
• Able to work highly independently across multiple protocols, sites and therapy areas.
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus.
• Works with high quality and compliance mind-set.
• Positive mindset, growth mindset, capable of working independently and being self-driven.
• Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

Experience Requirements:
Required:
• Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements:
Preferred:
• B.A./B.S. with strong emphasis in science and/or biology.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Accountability, Accountability, Adaptability, Adverse Event Reporting System, Biopharmaceutical Industry, Biopharmaceuticals, Clinical Medicine, Clinical Research Methods, Clinical Sciences, Clinical Site Management, Clinical Study Management, Clinical Testing, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Reporting, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Healthcare Innovation, Management Process, Medical Research, Monitoring Control, Organizational Performance Management, Problem Solving, Protocol Adherence {+ 4 more}

Preferred Skills:

Job Posting End Date:

08/16/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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Mason & Co Federal Territory of Kuala Lumpur, Malaysia

Clinical Research Associate

Mason & Co Federal Territory of Kuala Lumpur, Malaysia

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Recruiter for the Life Sciences Industry | Associate Consultant at Mason & Co.

About the company

This employer is a multinational company specializing in clinical research and trial management services for the healthcare sector. Their comprehensive research solutions support medical advancement initiatives across multiple therapeutic areas and they have established themselves as a trusted and respected partner within the global healthcare research community.

About the job

In this position, you will be providing clinical oversight, site management and regulatory support services related to medical research studies. This role also involves contribution to data quality assurance activities in collaboration with clinical operations and sponsor teams.

Job Responsibilities:

• Provide site support through consultation on study protocol and regulatory matters
• Handle monitoring activities along with data verification at clinical research sites
• Work collaboratively with clinical teams on study implementation and compliance activities, offering guidance and assistance as necessary
• Develop monitoring reports and documentation as required for regulatory submissions
• Contribute to operational excellence by implementing best practices and driving quality improvements

Job Requirements:

• Bachelor's Degree in Life Sciences, Nursing, Medicine or other healthcare-related fields
• Minimum of 1 year working experience in clinical research or healthcare industry
• Ability to work independently and manage multiple study sites
• Excellent analytical, communication and problem-solving skills
• Extensive travel required to clinical research sites across assigned regions

What’s on offer:

• Exciting career progression opportunities in a leading industry player
• Competitive remuneration and benefits
• The chance to be part of a growing industry that makes a difference in people’s lives

Seniority level

• Seniority level Associate

Employment type

• Employment type Full-time

Job function

• Job function Quality Assurance, Research, and Project Management
• Industries Hospitals and Health Care, Public Health, and Health and Human Services

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