17 Icon Plc jobs in Malaysia

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Preferred Skills:

Job Posting End Date:

*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

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.

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
10/11/2025

• A job posting is effective until PM 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

BP Healthcare is seeking a highly organized and detail-oriented Clinical Research Coordinator (CRC) to manage the end-to-end operations of multiple clinical trials. This critical role ensures patient safety, regulatory compliance, accurate data collection, and efficient site and trial administration.

The CRC will the primary contact for clinical trial participants, researcher, sponsors, CROs, and internal stakeholders. You'll play a central role in the planning, execution, and close-out phases of clinical trials, contributing directly to the success of our research initiatives.

• Taman Megah, Petaling Jaya
• Glenmarie, Shah Alam
• Medan Tuanku, Kuala Lumpur
• Ipoh, Perak
• Nationwide

1. Clinical Trial Management & Execution

• Manage the daily operations of multiple clinical trials from start-up to close-out.
• Coordinate with researchers, site staff, sponsors, and CROs to ensure protocol adherence and timelines.
• Conduct pre-screening, scheduling, and logistics management for participants.
• Ensure compliance with Good Clinical Practice (GCP), SOPs, and regulatory standards.
• Accurately collect, enter, and verify trial data; assist with resolving data queries.
• Perform basic physical assessments and record vital signs where appropriate.

2. Trial & Site Administration

• Track essential documents and maintain clinical trial databases and trackers.
• Coordinate study materials, supplies, and labelling in alignment with study protocols.
• Manage translations and cross-border study documentation.
• Update internal systems such as trial trackers and investigator databases.

3. Document Management

• Draft, distribute, and archive clinical documents including eTMF and investigator files.
• Preparation of patient materials, instruction sheets, and logs.
• Ensure proper documentation and disposal of clinical supplies.

4. Regulatory & Site Start-Up

• Assist in preparing submission packages for Institutional Review Boards (IRB/ERC) and Health Authorities.
• Collect and validate site evaluation and activation documents.
• Maintain insurance certificates and approvals records.

5. Budgeting, Contracts & Payments

• Work with finance teams to develop, manage, and reconcile site and country budgets.
• Support the preparation, negotiation, and execution of Clinical Trial Agreements (CTAs).
• Payment Processing: Facilitate the process payments to investigators, vendors and grant recipients.
• Maintain accurate financial tracking and documentations.

6. Meetings, Communication & Travel

• Support local investigator meetings including material prep, venue coordination, and logistics.
• Provide timely updates to supervisors and stakeholders on study progress trials.
• Be open to travel to monitor trial sites, transport samples, or attend relevant training sessions.

7. Quality & Team Support

• Assist to recommend improvements to trial processes.
• Contribute to a positive and collaborative team environment.
• Ensure consistent adherence to ethical and regulatory standards.

Outlet Assistant:

1. Support sales, marketing, and client relationship activities.
2. Perform and validate lab tests in compliance with ISO/SOP standards.
3. Maintain equipment, supplies, and quality control programs.
4. Assist doctors and nurses in patient care and clinical procedures.
5. Handle patient registration, billing, and record management.

• Bachelor's degree in Science, Nursing, Health Science, Medical, or related fields.
• Minimum 3 years of experience in clinical research or related roles (preferred).
• Strong knowledge of clinical trial regulations, GCP, and ethical standards.
• Must have Good Clinical Practice certificate
• Excellent interpersonal and communication skills; able to work independently with minimal supervision.
• Highly organized with strong attention to detail and documentation.
• Proficient in Microsoft Office Suite and relevant clinical trial software.

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.

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

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

Current Employees apply HERE

Current Contingent Workers apply HERE

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

Employee Status
Regular

Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid

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

Preferred Skills
Job Posting End Date
08/16/2025

• A job posting is effective until PM 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

1. Plan and managing the types of information collected from patients, healthcare providers and medical researchers from Beacon Hospital

2. Provide support to the clinical research department on analytics execution

3. Manage and processing the raw datasets and conducted statistical analysis. Data sources include medical and pharmacy claims data, hospital data, electronic medical record data, and prospective observational study data.

4. Understand data and conduct observational data analyses including data management and statistical analysis

5. Check data sets for logical consistency and accuracy prior to analysis

6. Manipulate data into correct format for analysis purposes, e.g., recode variables, create new variables, stack data, run tables and perform analytics

7. Collaborate and assist HOD to scope and design projects including protocol planning and development

Prepares manuscript and publication

Job Type: Full-time

Pay: RM2, RM3,000.00 per month

Benefits:

• Free parking
• Health insurance
• Maternity leave
• Opportunities for promotion
• Professional development

Work Location: In person

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.

#LI-Hybrid

#CRAFSAJD

#CRASDAJD

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

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

PSI’s business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market. By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients.

We offer an inspiring story of the company that has grown organically from a handful of countries to global presence. PSI is a mature company with standards and practices, but we do not stand still. Every day, there is a figurative Everest to climb, and you will not get bored here.

We’re searching for a knowledgeable, team-oriented Senior CRA to manage the clinical aspects of full-service globalprojects in Malaysia. As a Senior CRA at PSI, you will work on the frontline of communication with project stakeholders, ensuring the successful conduct of clinical trials in a variety of therapeutic indications. You willmaintain the highest quality standards in the industry, whileperforming and supervisingstudy start-up, clinical monitoring and site management activities on the country/regionallevel.

You will become one of our first team members in Malaysia and contribute to the development of PSI Operations. The candidate can be based anywhere in Malaysia.

You will:

• Supervise study activities, timelines, milestones, and schedules on the country level.
• Conduct and report all types of onsite monitoring visits.
• Be involved in study set-up, including site contract and budget negotiations.
• Be responsible for site communication and management.
• Ensure consistency of all study processes and identify country differences.
• Oversee maintenance of study-specific and corporate tracking systems.
• Contribute to the development and update of project planning documents, essential documents, and project instructions.
• Be a point of contact for in-house support services, contractors, global cross-functional teams, and vendors.
• Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
• Development of local language materials including local language Informed Consents and translations.
• Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.

The ideal candidate must possess the following qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, or Registered Nursing; or an equivalent combination of education, training, and experience. Registered pharmacists are strongly preferred.
• Minimum of 4-5 years of demonstrable, independent on-site monitoring experience or equivalent expertise.
• Extensive experience in conducting all types of monitoring visits in Phase II and/or III clinical trials.
• Proficiency in feasibility assessment and study set-up processes is highly desirable.
• Specialized experience in Oncology or Hematology therapeutic indications is a significant advantage.
• Demonstrated ability to plan effectively, multitask efficiently, and thrive in a dynamic team environment.
• Superior communication, collaboration, and problem-solving skills are essential.
• Willingness and ability to travel extensively within Malaysia is a prerequisite for this position.

How are we different?

PSI is privately owned by the very people who founded the company more than 25 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms.

Growth Opportunities

PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.