47 Research Associate jobs in Malaysia

This job is a Research Associate at Simplexify Consulting, where you'll explore topics like energy and transport. You might like this job because you enjoy digging into data, analyzing trends, and helping create insightful reports!

Simplexify Consulting is a boutique consultancy specialising in infrastructure advisory and management consultancy.

We are looking for a Research Associate who will perform research across various infrastructure sectors, including energy, transport, and water. Your responsibilities include:

1. Conducting research, understanding relevant markets and industries, and identifying information required for projects
2. Interpreting, analyzing, and quantifying data and information
3. Performing market assessments
4. Assisting in the preparation of articles and reports

Job Requirements

We are seeking candidates who meet the following criteria:

• Strong academic credentials from reputable universities, preferably in business, finance, engineering, or mathematics. Candidates with other degrees are also encouraged to apply.
• Strong analytical, critical thinking, and problem-solving skills
• Ability to work collaboratively
• Ability to thrive in a fast-paced, dynamic, and demanding environment
• Proficiency in English (speaking, listening, reading, and writing)
• Proficiency in Microsoft Office (Excel, PowerPoint, Word)

Skills

• Research
• Market Research
• Analytical Skills
• Data Analysis
• Report Writing
• Microsoft Excel

Company Benefits Personal Development

Ready to enhance your skills? The learning curve is steep — like a roller-coaster ride! Fun and exhilarating.

Snack enthusiast? Our pantry is stocked — you might even get to decide what's in it! Wellness benefits include gym or yoga membership claims.

About Us

Simplexify Consulting is a business advisory firm focusing on financial advisory and management consulting services. We aim to solve our clients' challenges while maintaining high standards of quality. We tailor solutions to each unique business problem by leveraging our collective expertise. Our experience spans various industries and regions.

Our vision is to be Southeast Asia's most personalized talent ecosystem, elevating human progress by fostering career and company growth.

Community Guidelines | Privacy Policy | Terms & Conditions | Site Map

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This job is a Research Associate at Simplexify Consulting, where you'll explore topics like energy and transport. You might like this job because you enjoy digging into data, analyzing trends, and helping create insightful reports! Simplexify Consulting is a boutique consultancy specialising in infrastructure advisory and management consultancy. We are looking for a Research Associate who will perform research across various infrastructure sectors, including energy, transport, and water. Your responsibilities include: Conducting research, understanding relevant markets and industries, and identifying information required for projects Interpreting, analyzing, and quantifying data and information Performing market assessments Assisting in the preparation of articles and reports Job Requirements

We are seeking candidates who meet the following criteria: Strong academic credentials from reputable universities, preferably in business, finance, engineering, or mathematics. Candidates with other degrees are also encouraged to apply. Strong analytical, critical thinking, and problem-solving skills Ability to work collaboratively Ability to thrive in a fast-paced, dynamic, and demanding environment Proficiency in English (speaking, listening, reading, and writing) Proficiency in Microsoft Office (Excel, PowerPoint, Word) Skills

Research Market Research Analytical Skills Data Analysis Report Writing Microsoft Excel Company Benefits

Personal Development

Ready to enhance your skills? The learning curve is steep — like a roller-coaster ride! Fun and exhilarating. Snack enthusiast? Our pantry is stocked — you might even get to decide what's in it! Wellness benefits include gym or yoga membership claims. About Us

Simplexify Consulting is a business advisory firm focusing on financial advisory and management consulting services. We aim to solve our clients' challenges while maintaining high standards of quality. We tailor solutions to each unique business problem by leveraging our collective expertise. Our experience spans various industries and regions. Our vision is to be Southeast Asia's most personalized talent ecosystem, elevating human progress by fostering career and company growth. Community Guidelines | Privacy Policy | Terms & Conditions | Site Map

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As a Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be partnering with a well-known global pharmaceutical company with a strong portfolio in cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation medicines.

You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is for you if you are looking for an environment where people feel they belong and are empowered to reach their full potential, perform at their best and make a valued contribution to saving lives.

What you will be doing:

• Perform all aspects of CRA duties from site selection, site initiation, through to site routine monitoring visits through to close-out visits and database lock.
• Contributes to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e., operating manuals, monitoring guidelines, etc.);
• Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by the Project Manager.
• Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department.
• Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports.

You are:

• Degree in Pharmacy or any related course.
• 1+ years prior monitoring experience with global trials.
• Experience with clinical trial set up and contract negotiation preferred, but not essential.
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP, good knowledge of local regulations.
• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

Why ICON?

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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To be an active member of the research team within the Center of Technology, Strategy and Sustainability (CTSS) to be a leading center of excellence and research on business strategies and technology in emerging markets and their socio-political environment. The CTSS hosts a flagship research project and various smaller research projects each year, while actively engaging the academic, policymaking, private sector, and public audiences on the research outputs from the center.

The research associate is an important member in assisting in conducting, publishing, and disseminating rigorous and impactful research. Currently, the CTSS is focusing research on the area of energy transition and renewable energy, including a focus on the energy transition landscape in Malaysia, biomass energy, carbon markets, and other topics.

Key Responsibilities

• To actively assist and perform the research center flagship research project, from planning and initiating research project, literature review, data collection, analysis, writing, and dissemination, in order to ensure the successful publication of research output within the planned period.
• To actively lead, with guidance from the senior members of the research center, in personal research project, from planning and initiating research project, literature review, data collection, analysis, writing, and dissemination, in order to ensure the successful publication of research output within the planned period.
• To assist in organizing and running the research events, workshops, seminars, and events of the research center for the dissemination of the research output and greater engagements between the research centers and the wider research community and public.
• To assist in the research output dissemination to relevant stakeholders from policymakers, private sector stakeholders, civil society stakeholders, and the general public to create research impact from the research project.
• To assist in the general promotion of the research center output and activities to increase awareness of the research center.
• To assist in the engagement with the wider research community globally for the research center to build a wider research network for the research center.
• Participate in the general administrative activities of the center.

Minimum Qualification and Skills Required

• Bachelor Degree in Social Sciences preferred; fresh graduates are welcomed to apply.
• Good command of English and Malay (spoken and written).
• Basic knowledge in research data collection and analysis methodology and tools either in qualitative or quantitative methods.
• Ability to actively learn qualitative and quantitative research data collection and analysis methodology.

Application Process

Interested applicants are urged to submit their resume, cover letter, and any relevant additional documentation.

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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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Join to apply for the Clinical Research Associate role at Cancer Research Malaysia

Join to apply for the Clinical Research Associate role at Cancer Research Malaysia

Direct message the job poster from Cancer Research Malaysia

HR Management | Recruitment | Employee Relations | Training & Development | Onboarding Specialist

Scope / Purpose of Job:

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
• Resourceful and able to multitask
• Certified GCP
• Adopts a pro-active attitude to work
• Passion for CRMY's mission

Seniority level

• Seniority level Associate

Employment type

• Employment type Contract

Job function

• Job function Science, Research, and Strategy/Planning
• Industries Research and Research Services

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Join to apply for the Clinical Research Associate role at MSD

Join to apply for the Clinical Research Associate role at MSD

• 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

• 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.

• 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.

Seniority level

• Seniority level Associate

Employment type

• Employment type Full-time

Job function

• Job function Administrative
• Industries Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at MSD by 2x

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Petaling Jaya, Selangor, Malaysia 4 days ago

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 3 weeks ago

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 week ago

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 day ago

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 weeks ago

Petaling Jaya, Selangor, Malaysia 2 months ago

Petaling Jaya, Selangor, Malaysia 1 day ago

Kuala Lumpur City, Federal Territory of Kuala Lumpur, Malaysia 4 hours ago

Clinical Studies Specialist Coordinator II

Petaling Jaya, Selangor, Malaysia 1 month ago

Petaling Jaya, Selangor, Malaysia 2 days ago

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 months ago

Trial Capabilities Senior Associate For Asia Pacific Region Research Assistant/Analyst/Associate, Global Credit - Ratings and Monitoring Rep II - Customer Service Shared Services

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 3 weeks ago

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Join to apply for the

Clinical Research Associate

role at

MSD Join to apply for the

Clinical Research Associate

role at

MSD • 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 • 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. • 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. Seniority level

Seniority level Associate Employment type

Employment type Full-time Job function

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Petaling Jaya, Selangor, Malaysia 4 days ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 3 weeks ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 week ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 day ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 weeks ago Petaling Jaya, Selangor, Malaysia 2 months ago Petaling Jaya, Selangor, Malaysia 1 day ago Kuala Lumpur City, Federal Territory of Kuala Lumpur, Malaysia 4 hours ago Clinical Studies Specialist Coordinator II

Petaling Jaya, Selangor, Malaysia 1 month ago Petaling Jaya, Selangor, Malaysia 2 days ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 months ago Trial Capabilities Senior Associate For Asia Pacific Region

Research Assistant/Analyst/Associate, Global Credit - Ratings and Monitoring

Rep II - Customer Service Shared Services

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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Cancer Research Malaysia Direct message the job poster from Cancer Research Malaysia HR Management | Recruitment | Employee Relations | Training & Development | Onboarding Specialist

Scope / Purpose of Job: 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 Resourceful and able to multitask Certified GCP Adopts a pro-active attitude to work Passion for CRMY's mission Seniority level

Seniority level Associate Employment type

Employment type Contract Job function

Job function Science, Research, and Strategy/Planning Industries Research and Research Services Referrals increase your chances of interviewing at Cancer Research Malaysia by 2x Get notified about new Clinical Research Associate jobs in

Subang Jaya, Selangor, Malaysia . Petaling Jaya, Selangor, Malaysia 5 days ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 3 weeks ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 week ago Petaling Jaya, Selangor, Malaysia 3 days ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 day ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 weeks ago Kuala Lumpur City, Federal Territory of Kuala Lumpur, Malaysia 21 hours ago Petaling Jaya, Selangor, Malaysia 2 months ago Petaling Jaya, Selangor, Malaysia 2 days ago Clinical Studies Specialist Coordinator II

Petaling Jaya, Selangor, Malaysia 1 month ago Petaling Jaya, Selangor, Malaysia 3 days ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 months ago Trial Capabilities Senior Associate For Asia Pacific Region

Research Assistant/Analyst/Associate, Global Credit - Ratings and Monitoring

Rep II - Customer Service Shared Services

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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