What Jobs are available for Clinical Affairs in Malaysia?

Senior HR Executive | Payroll Management | Detail-Oriented Job Purpose

To monitor sales & marketing activities aligning with respective internal / external regulation.

To support sales and marketing staffs by providing scientific knowledge and perspective.

To manage good rapport with healthcare professionals.

To keep abreast with healthcare business activities and current market situation.

To play a key role in ensuring regulatory compliance, managing pharmacovigilance processes, and supporting the overall safety of our products in the market.

Job Description

Advisory and Deputy Drug Safety Office Role

Support HOE’s Business as the Provider and Enabler for the scientific needs of the Company.

Assist in the development of Product Medical Advisory Board.

Contribute to the development and maintenance of knowledge regarding competitive landscape and communicate intelligence to the marketing team as appropriate.

Give technical and medical advice in the evaluation and management of current and future products to ensure business potential of the product.

Support and provide the Local Safety Officer with necessary expert advice from medical and clinical viewpoint in order for the company to fulfill its Pharmacovigilance responsibilities.

Assist in the implementation, maintenance, and monitoring of the pharmacovigilance system to ensure compliance with local and international drug safety regulations.

Monitor and review safety data from clinical trials, post-marketing surveillance, and spontaneous reports to identify any potential safety concerns.

Scientific & Medical Affairs Role

To support Medical Affairs Manager on aspects of Scientific and Medical Affairs.

Train the medical, marketing and sales teams on the disease background and pharmaceutical and clinical data of the products.

Provide scientific & medical support on product promotion activities, including material development such as Guidelines, Pamphlets, Brochures, Q&A and etc., advertising messages, CMEs and relationship building activities, directed to healthcare professionals, patients and lay public and ensure that all of these comply with legal, local regulatory, industry and corporate guidelines & Code of Ethics.

Monitor and challenge unfounded and misleading promotional claims and unethical programs by competitors to ensure fair marketing promotions.

Provide scientific information and documents required by health authorities in order to facilitate approval of product registration.

Provide response to queries or complaints from health authorities, healthcare professionals and the lay public on the company products.

Provide training to internal teams, such as sales and marketing, on product science, clinical data, and disease state knowledge.

Organize and conduct educational presentations and discussions to healthcare providers.

Engage in scientific discussions with healthcare professionals to support clinical research efforts and identify research opportunities.

Strong scientific acumen and ability to communicate complex data effectively to a variety of audiences.

Job Requirements

Bachelor's degree in Pharmaceutical related education.

Minimum 3 years of experience in Medical Science Liaison, Pharmacovigilance or Drug Safety within the pharmaceutical industry.

International and local pharmaceutical guidelines and government laws.

Clear knowledge of international and local pharmaceutical guidelines and government laws.

Proven ability to communicate clearly with physicians and health-care professionals regarding medical products, procedures and research data.

Proven ability to build strong relationships with the medical community and other clientele.

Seniority level

Executive

Employment type

Full-time

Job function

Science, Research, and Writing/Editing

Pharmaceutical Manufacturing

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Provide accurate, current, and balanced scientific and clinical information to KOLs, healthcare providers, academic institutions, and other stakeholders.

Facilitate scientific discussions on disease state, treatment paradigms, safety, efficacy and real-world evidence.

Support and lead continuing medical education (CME) activities, advisory boards, scientific symposium, workshops, and presentations.

KOL Identification & Relationship Management Identify, map, and develop relationships with key opinion leaders, subject matter experts, and therapeutic area specialists.

Maintain strong, ethical, and compliant relationships with KOLs, keeping regular contact and sharing insights with internal teams.

Clinical Trials & Investigator Support Facilitate clinical trials, investigator-initiated studies (IIS), post-marketing studies, and real-world evidence generation.

Assist in site identification, protocol review, data interpretation, and ensure compliance with GCP, regulatory, and ethical standards.

Medical Strategy Input Contribute insights to medical and commercial strategy including project planning, launch readiness, brand lifecycle management and value narratives.

Monitor and communicate emerging clinical, scientific, and competitive data; identify trends, unmet needs, and implications for strategy.

Medical Information & Safety Respond to unsolicited medical queries in a timely, accurate, and compliant manner.

Work with pharmacovigilance teams to ensure adverse event reporting and safety communications as required.

Internal Collaboration & Communication Serve as internal resource for medical training for sales & marketing teams.

Ensure internal stakeholders (marketing, regulatory, clinical development) are updated on scientific developments, field insights, and feedback from HCPs.

Compliance & Ethical Standards Adhere to local and international regulatory, legal, and ethical guidelines.

Ensure all interactions are compliant with company policies and external codes of conduct.

Travel & Territory Responsibilities Manage assigned territory, travel routinely to meet HCPs, KOLs, and attend conferences.

Organize and participate in medical/scientific meetings, field visits, and customer engagements.

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Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The MSL Oncology - Solid Tumor will play a crucial role in AbbVie's preparedness for the launch of new oncology products that require companion molecular diagnostics. This individual will be responsible for helping assess AbbVie's readiness for new precision medicine assets, addressing evidence and educational gaps and collaborating with external scientific stakeholders to develop partnerships that support and expedite opportunities for patients to access AbbVie's precision medicines.
Responsibilities:
+ Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to AbbVie.
+ Ensure a strong medical and scientific presence for AbbVie in key academic centers by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to AbbVie.
+ Support internal teams such as sales, marketing and members of the Affiliate Brand Team to develop their scientific and technical expertise through the delivery of scientific update presentations. Work collaboratively and cross-functionally with other in-field members while retaining functional independence.
+ Assist in the initiation; oversight and follow up of assigned clinical studies and medical projects initiated within the therapeutic area for which the MSL carries responsibility (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV). All such activities must comply with applicable local laws, guidelines, codes of practice, SOPs, and AbbVie R&D (GPRD) SOPs.
+ Act as the point of contact with thought leaders to facilitate Investigator Initiated Study (IIS) ideas and requests for support to the local and global medical teams as appropriate.
+ Serve as a point of contact within the Medical Affairs team for thought leaders and external experts within an assigned geographic area to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant AbbVie medicines, to support their safe, effective and appropriate use.
+ Deliver credible presentations on scientific matters to physicians, individually or in groups (meetings, clinical sessions, etc.), were requested, but with the focus on Tier 1 and 2 thought leaders.
+ Participate in the selection process to identify appropriately qualified thought leaders the Company would wish to engage in collaborative efforts - such as potential research collaborations, or educational and advisory roles (Advisory Boards, Congresses, Symposia, etc.); while ensuring a high level of scientific or educational integrity in these collaborative efforts.
+ Facilitate medical and scientific field intelligence - for example, competitor research and medical strategies, educational activities - and communicate, where appropriate, within the Company.
+ Attend relevant scientific meetings and Conferences. Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform AbbVie strategic priorities and initiatives.
Upon request, assist physicians with requests for access to AbbVie medicines on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements.
+ Provide key thought leaders / external experts and internal medical and clinical teams with scientific and technical support for publications of scientific or medical interest.
+ Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice.
Location:
This function is typically field based role. Typically, up to 20% of an individual's time may be spent working in the affiliate medical team head office - the remainder of time being spent as field based. This is subject to local needs, and the discretion of the ASEAN Medical Director.
Qualifications
+ Medical, Pharmacy or other bachelor's degree in scientific discipline or higher (PhD)
+ A background in diagnostics, the diagnostic industry, medical affairs or a related field, along with experience in working closely with the pharmaceutical industry.
+ Strong understanding of precision medicine and companion diagnostics, including the regulatory and payer landscape in Singapore.
+ Excellent communication and proven relationship-building skills in effectively establishing new links with external stakeholders.
+ Possess strong organizational skills, the ability to work collaboratively with cross-functional teams.
+ Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Medical Science Liaison, Oncology - Solid Tumor AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Overview The MSL Oncology – Solid Tumor will play a crucial role in AbbVie’s preparedness for the launch of new oncology products that require companion molecular diagnostics. This individual will be responsible for helping assess AbbVie’s readiness for new precision medicine assets, addressing evidence and educational gaps and collaborating with external scientific stakeholders to develop partnerships that support and expedite opportunities for patients to access AbbVie’s precision medicines.

Responsibilities

Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to AbbVie.

Ensure a strong medical and scientific presence for AbbVie in key academic centers by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to AbbVie.

Support internal teams such as sales, marketing and members of the Affiliate Brand Team to develop their scientific and technical expertise through the delivery of scientific update presentations. Work collaboratively and cross-functionally with other in-field members while retaining functional independence.

Assist in the initiation; oversight and follow up of assigned clinical studies and medical projects initiated within the therapeutic area for which the MSL carries responsibility (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV). All such activities must comply with applicable local laws, guidelines, codes of practice, SOPs, and AbbVie R&D (GPRD) SOPs.

Act as the point of contact with thought leaders to facilitate Investigator Initiated Study (IIS) ideas and requests for support to the local and global medical teams as appropriate.

Serve as a point of contact within the Medical Affairs team for thought leaders and external experts within an assigned geographic area to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant AbbVie medicines, to support their safe, effective and appropriate use.

Deliver credible presentations on scientific matters to physicians, individually or in groups (meetings, clinical sessions, etc.), where requested, with a focus on Tier 1 and 2 thought leaders.

Participate in the selection process to identify appropriately qualified thought leaders the Company would wish to engage in collaborative efforts – such as potential research collaborations, or educational and advisory roles (Advisory Boards, Congresses, Symposia, etc.); while ensuring a high level of scientific or educational integrity in these collaborative efforts.

Facilitate medical and scientific field intelligence – for example, competitor research and medical strategies, educational activities – and communicate, where appropriate, within the Company.

Attend relevant scientific meetings and Conferences. Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform AbbVie strategic priorities and initiatives. Upon request, assist physicians with requests for access to AbbVie medicines on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements.

Provide key thought leaders / external experts and internal medical and clinical teams with scientific and technical support for publications of scientific or medical interest.

Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice.

Location: This function is typically field based role. Typically, up to 20% of an individual’s time may be spent working in the affiliate medical team head office – the remainder of time being spent as field based. This is subject to local needs, and the discretion of the ASEAN Medical Director.

Qualifications

Medical, Pharmacy or other bachelor’s degree in scientific discipline or higher (PhD)

A background in diagnostics, the diagnostic industry, medical affairs or a related field, along with experience in working closely with the pharmaceutical industry.

Strong understanding of precision medicine and companion diagnostics, including the regulatory and payer landscape in Singapore.

Excellent communication and proven relationship-building skills in effectively establishing new links with external stakeholders.

Possess strong organizational skills, the ability to work collaboratively with cross-functional teams.

Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: level

Entry level

Employment type

Full-time

Job function

Research, Analyst, and Information Technology

Industries

Pharmaceutical Manufacturing and Biotechnology Research

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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: R

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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:

Data generated at site are complete, accurate and unbiased. 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. Merck & Co., Inc. is an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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Essential Duties and Responsibilities Clinical Function Ensure the smooth and efficient day‑to‑day operation of clinical trials.

Schedule and manage subject visits, including unscheduled visits, as per protocol requirements.

Recruit, consent, screen, instruct, and coordinate research subjects.

Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Dexcom’s SOPs.

Identify and escalated safety events and major protocol deviations.

Assist with assessing trends for safety and protocol deviations and communicate findings to the PI. Propose and implement corrective and preventative actions.

Trial Planning and Coordination Provide documents and information for Ethics Committee applications.

Perform tasks as delegated by the Principal Investigator in accordance with the protocol, SOPs, and applicable guidelines.

Assist in finding potential subjects through pre‑screening activities.

Prepare supplies and account for devices required for clinical studies.

Set up IT equipment for studies.

Develop clinical study materials (including, but not limited to, source documentation, IRB submissions, training slides, etc.).

Data Collection and Management Ensure timely and accurate completion of Case Report Forms (CRF/e‑CRF) and resolve queries.

Maintain essential study documents/files and make records available for review, including device accountability tracking.

Keep an ongoing record and assessment of adverse events (AEs) and serious adverse events (SAEs).

Assist with departmental audits of clinical studies and procedures.

Compliance and Ethics Ensure trial practices reflect ethical and legal standards for clinical trials.

Adhere to all Dexcom SOPs, ISO 14155:2020, and Malaysian Guideline for Good Clinical Practice.

Notify the Ethics Committee of SAEs and protocol deviations (PDs).

Prepare the site for monitoring, audit, and inspection, and implement recommended corrective actions.

Administrative Support Observe the progress of trial activities and communicate schedules/required procedures to the team.

Assist with dispensing participants’ compensation (if applicable).

Coordinate trial close‑out activities, including device investigation or disposal and archiving materials.

Involve in and contribute to all quality improvement activities of the department.

Collaborate with global Clinical PMO and study teams to establish and maintain study timelines.

Communicate effectively and professionally with coworkers, leadership, and study subjects.

Collaborate effectively with peers and leadership across departments and professionally interact/build relationships with FDA, IRB, and key opinion leaders.

Perform other duties as assigned under minimal supervision.

Required Qualifications Degree in nursing, sciences, or pharmacy. MBBS/MD with clinical experience will also be considered.

2‑5 years relevant working experience in clinical research.

Possess GCP Certification.

Proficient with MS Office Suite.

Excellent communication skills and ability to work effectively with multiple global functions.

Strong organizational skills and ability to manage competing priorities.

Strong critical thinking and independence.

Willing to work, hands‑on, in an extremely fast‑paced environment with high attention to details and accuracy.

Preferred Qualifications Experience in continuous glucose monitoring (CGM) or diabetes‑related studies.

Experience working closely with a global team.

Experience with Clinical Trial Management Systems (e.g. Veeva).

Application Questions

How many years' experience do you have as a clinical research associate (CRA)?

Which of the following statements best describes your right to work in Malaysia?

What's your expected monthly basic salary?

Which of the following types of qualifications do you have?

How many years' experience do you have as a Clinical Research Coordinator?

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Clinical Research Associate Join to apply for the

Clinical Research Associate

role at

Dexcom .

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we’re just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we’ve started: Improving human health.

Position Summary Join our dynamic and growing global team as a Study Coordinator (SC), where you’ll play a pivotal role in the conduct of clinical trials. You’ll be responsible for a variety of activities essential to the success of these trials, including trial start‑up activities, ongoing study management, and coordination of trial subjects at every stage of their clinical trial journey. As the main point of contact for trial subjects, you’ll work closely with the Principal Investigator (PI) to ensure the safety of patients and the integrity of data collected, in accordance with study protocol requirements, Good Clinical Practice (GCP), and applicable regulatory requirements.

Essential Duties and Responsibilities

Ensure the smooth and efficient day‑to‑day operation of clinical trials.

Schedule and manage subject visits, including unscheduled visits, as per protocol requirements.

Recruit, consent, screen, instruct, and coordinate research subjects.

Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Dexcom’s SOPs.

Identify and elevate safety events and major protocol deviations.

Assist with assessing trends for safety and protocol deviations and communicate findings to the PI. Propose and implement corrective and preventative actions.

Trial Planning and Coordination

Provide documents and information for Ethics Committee applications.

Perform tasks as delegated by the PI in accordance with the protocol, SOPs, and applicable guidelines.

Assist in finding potential subjects through pre‑screening activities.

Prepare supplies and account for devices required for clinical studies.

Set up IT equipment for studies.

Develop clinical study materials (including, but not limited to, source documentation, IRB submissions, training slides, etc.).

Data Collection and Management

Ensure timely and accurate completion of Case Report Forms (CRF/e‑CRF) and resolve queries.

Maintain essential study documents/files and make records available for review, including but not limited to device accountability tracking.

Keep an ongoing record and assessment of adverse events (AEs) and serious adverse events (SAEs).

Assist with departmental audits of clinical studies and procedures.

Compliance and Ethics

Ensure trial practices reflect ethical and legal standards for clinical trials.

Adhere to all Dexcom SOPs, ISO 14155:2020, and Malaysian Guideline for Good Clinical Practice.

Notify the Ethics Committee of SAEs and protocol deviations.

Prepare the site for monitoring, audit, and inspection, and implement recommended corrective actions.

Administrative Support

Observe the progress of trial activities and communicate schedules/required procedures to the team.

Assist with dispensing participants’ compensation (if applicable).

Coordinate trial close‑out activities, including device investigation or disposal and archiving materials.

Involve in and contribute to all quality improvement activities of the department.

Collaborate with global Clinical PMO and study teams to establish and maintain study timelines.

Communicate effectively and professionally with coworkers, leadership, and study subjects.

Collaborate effectively with peers and leadership across departments and professionally interact/build relationships with FDA, IRB, and key opinion leaders.

Perform other duties as assigned under minimal supervision.

Required Qualifications

Degree in nursing, sciences, or pharmacy; MBBS/MD with clinical experience will also be considered.

2‑5 years relevant working experience in clinical research.

Possess GCP Certification.

Proficient with MS Office Suite.

Excellent communication skills and ability to work effectively with multiple global functions.

Strong organizational skills and ability to manage competing priorities.

Strong critical thinking and independence.

Willing to work hands‑on in an extremely fast‑paced environment with high attention to detail and accuracy.

Preferred Qualifications

Experience in continuous glucose monitoring (CGM) or diabetes‑related studies.

Experience working closely with a global team.

Experience with Clinical Trial Management Systems (e.g., Veeva).

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees, or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

Seniority Level Not Applicable

Employment Type Full‑time

Job Function Research, Analyst, and Information Technology

Industry Medical Equipment Manufacturing

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As you develop your career as a Senior CRA or CRA, this role offers you the opportunity to plan and progress your career in the direction you choose. At IQVIA, we do not believe in a 'career ceiling.' You will be exposed to wider opportunities like operations management, dedicated customer solutions, project management and more. And you won't do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion opportunities and awards. Joining IQVIA will give you access to cutting-edge in-house technology and provide opportunities to work on global projects/ trials. You will be building a flexible, meaningful and fulfilling career with no limits.
**Your responsibilities will include:**
+ Performing site selection, initiation, monitoring, and close-out visits, plus maintaining appropriate documentation
+ Supporting the development of a subject recruitment plan
+ Establishing regular lines of communication plus administering protocol and related study training to assigned sites
+ Evaluating the quality and integrity of site practices - escalating quality issues as appropriate
+ Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
+ You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. You will need to have a good knowledge of applicable clinical research regulatory requirements.
**Qualifications:**
+ University degree in scientific discipline or healthcare
+ At least 1 year of on-site monitoring experience
+ Good knowledge of GCP and clinical research regulatory requirements
+ Good computer skills including MS Office
+ Excellent command of English language
+ Organizational, time management and problem-solving skills
+ Ability to establish and maintain effective working relationships with colleagues, managers, and customers.
+ Flexibility to travel.
**What you can expect:**
+ Working with different customers on global trials
+ Career development opportunities for those who are passionate in wanting to grow as part of the organization.
+ Leaders that support flexible work schedules/arrangement
+ Excellent working environment in a stable, international, reputable company
+ Programs to help you build your technical skills, therapeutic knowledge and regular refreshers for updates in the regulatory landscape
+ Attractive remuneration package.
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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
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