Clinical Research Associate

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Kuala Lumpur; Vor Ort; MYR 120.000 - 180.000; Vollzeit

Zusammenfassung

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Kuala Lumpur is seeking a Clinical Research Associate to support Global Clinical Operations.

You will coordinate site regulatory submissions, manage essential documents, and collaborate with clinical sites to ensure timely IRB/EC approvals and documentation readiness. The role requires 2–3 years in clinical research, strong communication, and the ability to work independently within a team.

Qualifikationen

• Degree in a relevant scientific/healthcare subject or equivalent industry experience.
• 2–3 years of clinical research experience as a Research Coordinator or CRA/Study Start-up Specialist.
• Familiarity with clinical trial management systems (Siebel CTMS, Veeva) and eTMF/document control tools.
• Strong communication and the ability to work independently and in a team.

Aufgaben

• Coordinate and lead regulatory submissions and essential document collection for trials across start-up, enrollment, follow-up and closure.
• Document management across several studies and ensure regulatory readiness.
• Collaborate with sites to customize informed consent forms and align with business objectives.
• Build relationships with internal customers and clinical sites to become a subject matter expert in start-up regulatory processes.
• Assist with submission processes to meet IRB/EC timelines and mitigate start-up challenges.
• Prepare, complete and track regulatory, ICF and legal documentation.

Kenntnisse

Clinical trial coordination

Communication skills

Independent and team work

Problem solving

Ausbildung

Bachelor's degree in life sciences

Tools

Siebel CTMS

Veeva

Jobbeschreibung

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. 4.2 View all jobs

This role is based in Kuala Lumpur. Please note that Boston Scientific does not offer relocation support for this position. Applicants should be based in, or have valid work authorization for this location.

Purpose Statement:

The Clinical Research Associate supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO’s mission of building a world class shared clinical technology, process innovation and clinical operations team, in partnership with the company’s divisions, through technology enablement, high-touch customer service, study acceleration, and high-quality data collection.

Key Responsibilities:

• Coordinate and Lead: Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, drive site regulatory submissions and essential document collection for clinical research sites throughout start up, enrollment, follow-up, and closure of clinical trial activities.
• Document Management: Handle multiple sets of essential regulatory documents across several studies.
• Collaborate: Partner with clinical sites to negotiate and customize Informed Consent Forms (ICF). Collaborate cross functionally to achieve business objectives.
• Relationship Building: Develop and foster relationships with internal customers and clinical research sites to become a subject matter expert in site start-up regulatory processes.
• Problem Solving: Assist clinical research sites with application submission processes and approval tracking to meet target IRB/EC timelines. Problem-solve site start-up challenges to mitigate impact on service level agreements and study goals.
• Prepare and Track: Prepare, complete, and track required regulatory, ICF, and legal documentation.
• Quality Assurance: Document site and investigator readiness for participation across multiple studies.
• Support: Assist with internal quality audits and regulatory inspections.
• Maintain: Keep study-specific startup and close-out trackers updated.
• Update: Maintain site-specific metrics in Clinical Trial Management Systems and electronic Trial Master File (eTMF).
• Communicate: Provide updates to leadership on site start-up activities, investigator readiness, regulatory submission, and approval status.
• Compliance: Ensure adherence to regulatory requirements (ICH/GCP, MDR, GDPR) and internal SOPs/WI, policies, and procedures.

Requirements:

• Degree in relevant scientific/ healthcare subject or equivalent industry experience.
• Minimum 2 - 3 years of relevant experience and previous experience as a Research Coordinator or Clinical Research Associate/Study Start-up Specialist.
• Familiarity with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems/eTMF.
• Solid communication skills and ability to interact with clinical research site personnel.
• Ability to work independently and in a team environment.
• Strong problem-solving skills and learning agility.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding our footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding our footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.