job description
Join a global leader in pharmaceutical innovation as a Clinical Research Manager in the vibrant and dynamic setting of Bali, Indonesia. This is a rare opportunity to drive cutting-edge clinical trials, collaborate with cross-functional teams, and contribute to life-changing medical advancements in a multinational corporation (MNC) environment.
As a Clinical Research Manager, you will oversee the planning, execution, and monitoring of clinical studies, ensuring compliance with ICH-GCP guidelines, local regulations, and company SOPs. You will work closely with investigators, sponsors, and regulatory authorities to deliver high-quality data while maintaining ethical standards and operational excellence.
Bali offers a unique blend of professional growth and work-life balance, with its world-class infrastructure, international community, and breathtaking landscapes. Whether you're advancing your career in pharmaceutical research or seeking a role with global impact, this position provides the platform to excel.
Responsibility
- Lead and manage end-to-end clinical trial operations, from protocol development to final study close-out.
- Ensure compliance with ICH-GCP, FDA, EMA, and local regulatory requirements.
- Coordinate with investigators, CROs, and vendors to ensure timely and high-quality study execution.
- Develop and monitor study budgets, timelines, and resource allocation to optimize efficiency.
- Oversee data collection, analysis, and reporting to ensure accuracy and integrity.
- Liaise with regulatory authorities for submissions, inspections, and audits.
- Train and mentor clinical research associates (CRAs) and site staff on study protocols and SOPs.
- Identify and mitigate risks and issues that may impact study timelines or quality.
Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or related fields.
- Minimum 5+ years of experience in clinical research, with at least 2 years in a managerial role.
- Proven track record of managing Phase I-IV clinical trials in a pharmaceutical or CRO setting.
- In-depth knowledge of ICH-GCP, FDA 21 CFR, and ICH guidelines.
- Strong project management, leadership, and communication skills.
- Experience with CTMS, EDC systems, and eTMF is highly desirable.
- Fluency in English; additional languages are a plus.
- Willingness to travel regionally or internationally as needed.