32 Clinical Trials jobs in Malaysia

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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Interested applicants are invited to apply directly at the NUS Career Portal

Your application will be processed only if you apply via NUS Career Portal

We regret that only shortlisted candidates will be notified.

Job Description

A Research Fellow opening is available in the research group of Dr Jin Yueming, at the Department of Biomedical Engineering, National University of Singapore (NUS).

He/she will be required to work closely with the Principal Investigator (PI) on one or more research projects and perform the followings:

• To construct, analyze the medical imaging data, and define the data analytical tasks, which have the clinical value in the real-world employment.
• To develop novel models and algorithms for 2D or 3D medical vision tasks, such as surgical scene segmentation, depth estimation, etc.

Qualifications

• Possess a PhD in related discipline.
• Has strong self-motivation and curiosity.
• Higher priority goes to the candidates who have published first-author papers in top-tier journal and conference about medical imaging.
• Has good programming skills in one of the programming languages: c/c++, Matlab, Python
• Has project experience and values excellent teamwork.
• Proficient in written and verbal communication.
• Open to fixed-term contract

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Interested applicants are invited to apply directly at the NUS Career Portal

Your application will be processed only if you apply via NUS Career Portal

We regret that only shortlisted candidates will be notified.

Job Description

This research project involves the development of a versatile and high-performance robotic nursing platform for smart hospital systems. The research fellow is expected to contribute to the following aspects:
a) Designing a multifunctional and capable robotic nursing platform with an emphasis on patient caregiving and clinical logistics. The goal is to reduce the workload of human nurses, enabling them to focus on more complex and critical tasks.
b) Developing a robust and versatile control system for the proposed platform, leveraging foundation models or reinforcement learning to support functions such as interactive navigation and intelligent human–robot interaction.
c) Deploying and evaluating the developed robotic nursing platform in a real hospital environment to assess its effectiveness and practical impact.

Qualifications

• Min Bachelor’s degree in a relevant discipline, such as robotics, mechanical engineering, electrical/electronic engineering, computer science, or related fields.
• Solid experience in robotic control, particularly in reinforcement learning, imitation learning and foundation models. Publications in the robotics domain is a plus.
• Proficiency in advanced perception models.
• Hands-on experience in real-world robotics deployment and addressing the sim-to-real gap.
• Solid knowledge of numerical methods, including optimization, linear algebra, and geometry processing.
• Software programming in C/C++ and Python.
• Excellent analytical and computational skills.
• Understanding of software engineering principles, preferred worked experience on open-source software.
• The candidate must have the ability to work independently as well as part of a team with strong initiatives and have the curiosity to explore the unknown.
• Open to Fixed Term Contract.

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Interested applicants are invited to apply directly at the

NUS Career Portal Your application will be processed only if you apply via

NUS Career Portal We regret that only shortlisted candidates will be notified. Job Description

This research project involves the development of a versatile and high-performance robotic nursing platform for smart hospital systems. The research fellow is expected to contribute to the following aspects: a) Designing a multifunctional and capable robotic nursing platform with an emphasis on patient caregiving and clinical logistics. The goal is to reduce the workload of human nurses, enabling them to focus on more complex and critical tasks. b) Developing a robust and versatile control system for the proposed platform, leveraging foundation models or reinforcement learning to support functions such as interactive navigation and intelligent human–robot interaction. c) Deploying and evaluating the developed robotic nursing platform in a real hospital environment to assess its effectiveness and practical impact. Qualifications

• Min Bachelor’s degree in a relevant discipline, such as robotics, mechanical engineering, electrical/electronic engineering, computer science, or related fields. • Solid experience in robotic control, particularly in reinforcement learning, imitation learning and foundation models. Publications in the robotics domain is a plus. • Proficiency in advanced perception models. • Hands-on experience in real-world robotics deployment and addressing the sim-to-real gap. • Solid knowledge of numerical methods, including optimization, linear algebra, and geometry processing. • Software programming in C/C++ and Python. • Excellent analytical and computational skills. • Understanding of software engineering principles, preferred worked experience on open-source software. • The candidate must have the ability to work independently as well as part of a team with strong initiatives and have the curiosity to explore the unknown. • Open to Fixed Term Contract.

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AI Research Scientist (Medical Imaging) Digital Health Unit

We are seeking a highly motivated and creative AI Research Scientist to lead the development and improvement of AI models focused on oral lesion detection as part of the MeMoSA (Mobile Mouth Screening Anywhere) project. This role is pivotal in advancing our institution’s work in medical AI and setting the foundation for building a dedicated in-house AI research team in the long term. The candidate is expected to be able to work independently but will receive support from our established collaborators from Malaysia and the UK.

SCOPE / PURPOSE OF JOB

Short-Term Objectives (Year 1–2):

• Improve and optimize existing oral lesion detection AI models using the latest deep learning and computer vision techniques
• Develop novel, bias-aware , transparent , and explainable AI approaches to improve clinical trust and applicability.
• Collaborate with dental and medical experts to ensure clinical relevance and data validity.
• Conduct experiments, analyze model performance, and produce high-quality technical documentation and research papers.
• Manage data pre-processing pipelines, annotation quality checks, and model evaluation metrics.

Long-Term Objectives:

• Support the recruitment and mentoring of junior researchers or AI engineers as we build an internal AI team.
• Propose and lead new AI research projects in healthcare beyond oral lesion detection (e.g., predictive analytics, other imaging modalities, NLP for healthcare records).
• Contribute to the design of a scalable AI research infrastructure within the institution.

Qualifications

PhD or Master’s degree in Computer Science , Artificial Intelligence , Machine Learning , Biomedical Engineering , or related fields.

Experience:

• Minimum 2–3 years of hands-on experience in deep learning, preferably in medical imaging (experience with oral or dental images is a plus).
• Strong understanding of model fairness , bias mitigation , explainability (XAI) , and ethical AI .
• Proficiency with deep learning frameworks such as PyTorch or TensorFlow .
• Familiarity with tools and libraries for interpretability (e.g., SHAP, LIME, Grad-CAM).
• Track record of publications in reputable AI or medical imaging conferences/journals is highly desirable.
• Experience in leading small research or development projects is a plus.

Preferred Qualities

• Creative and independent thinker who can bring new ideas to the table.
• Passion for responsible AI development and real-world healthcare applications.
• Strong communication skills and the ability to work cross-functionally with clinicians, researchers, and software teams.

Why Join Us?

• Be at the forefront of AI innovation in healthcare with real clinical impact.
• Opportunity to shape the future of an in-house AI research unit.
• Work closely with a diverse team of clinicians, researchers, and institutional leaders.
• Access to rich clinical datasets and institutional support for high-impact research.

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.

#J-18808-Ljbffr

AI Research Scientist (Medical Imaging) Digital Health Unit

We are seeking a highly motivated and creative

AI Research Scientist

to lead the development and improvement of AI models focused on

oral lesion detection

as part of the MeMoSA (Mobile Mouth Screening Anywhere) project. This role is pivotal in advancing our institution’s work in medical AI and setting the foundation for building a dedicated in-house AI research team in the long term. The candidate is expected to be able to work independently but will receive support from our established collaborators from Malaysia and the UK. SCOPE / PURPOSE OF JOB Short-Term Objectives (Year 1–2): Improve and optimize existing oral lesion detection AI models using the latest deep learning and computer vision techniques Develop novel,

bias-aware ,

transparent , and

explainable

AI approaches to improve clinical trust and applicability. Collaborate with dental and medical experts to ensure clinical relevance and data validity. Conduct experiments, analyze model performance, and produce high-quality technical documentation and research papers. Manage data pre-processing pipelines, annotation quality checks, and model evaluation metrics. Long-Term Objectives: Support the recruitment and mentoring of junior researchers or AI engineers as we build an internal AI team. Propose and lead new AI research projects in healthcare beyond oral lesion detection (e.g., predictive analytics, other imaging modalities, NLP for healthcare records). Contribute to the design of a scalable AI research infrastructure within the institution. Qualifications PhD or Master’s degree in

Computer Science ,

Artificial Intelligence ,

Machine Learning ,

Biomedical Engineering , or related fields. Experience: Minimum

2–3 years of hands-on experience

in deep learning, preferably in

medical imaging

(experience with oral or dental images is a plus). Strong understanding of

model fairness ,

bias mitigation ,

explainability (XAI) , and

ethical AI . Proficiency with deep learning frameworks such as

PyTorch

or

TensorFlow . Familiarity with tools and libraries for interpretability (e.g., SHAP, LIME, Grad-CAM). Track record of publications in reputable AI or medical imaging conferences/journals is highly desirable. Experience in leading small research or development projects is a plus. Preferred Qualities Creative and independent thinker who can bring new ideas to the table. Passion for responsible AI development and real-world healthcare applications. Strong communication skills and the ability to work cross-functionally with clinicians, researchers, and software teams. Why Join Us? Be at the forefront of AI innovation in healthcare with real clinical impact. Opportunity to shape the future of an in-house AI research unit. Work closely with a diverse team of clinicians, researchers, and institutional leaders. Access to rich clinical datasets and institutional support for high-impact research. 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.

#J-18808-Ljbffr

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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