job description
Are you a seasoned Clinical Project Operations Manager with a passion for driving excellence in early-phase research? JobStudio is seeking a dynamic leader to oversee and execute clinical studies in a fast-paced Clinical Research Unit (CRU) environment in Bali, Indonesia.
In this high-impact role, you will lead cross-functional teams to ensure seamless study execution, compliance with regulatory standards, and timely delivery of results. Your expertise in clinical operations will be instrumental in optimizing processes, mitigating risks, and fostering collaboration between sponsors, investigators, and internal stakeholders.
If you thrive in a challenging, innovative setting and have a proven track record in managing clinical trials, we invite you to apply and take the next step in your career with a forward-thinking organization committed to advancing medical research.
Responsibility
- Lead and oversee the execution of clinical studies from initiation to close-out, ensuring adherence to protocols, timelines, and budgets.
- Manage cross-functional teams, including clinical monitors, data managers, and site coordinators, to ensure high-quality deliverables.
- Develop and implement operational strategies to optimize study efficiency, reduce costs, and mitigate risks.
- Ensure compliance with ICH-GCP, local regulations, and sponsor requirements throughout the study lifecycle.
- Serve as the primary point of contact for sponsors, investigators, and internal stakeholders, providing clear communication and issue resolution.
- Monitor study progress, identify bottlenecks, and implement corrective actions to maintain project timelines.
- Contribute to the development of SOPs, training materials, and best practices for clinical operations.
- Collaborate with business development teams to assess feasibility, propose solutions, and secure new projects.
Qualifications
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field; advanced degree (e.g., MSc, MBA) preferred.
- Minimum 7+ years of experience in clinical research, with at least 3 years in a leadership role (e.g., Clinical Project Manager, Operations Manager).
- Proven experience managing early-phase (Phase I-II) clinical trials in a CRU or similar environment.
- Strong knowledge of ICH-GCP, FDA, and local regulatory requirements (Indonesian regulations a plus).
- Excellent project management, organizational, and problem-solving skills with the ability to handle multiple priorities.
- Demonstrated ability to lead teams, mentor staff, and foster a collaborative work culture.
- Proficiency in clinical trial management systems (CTMS) and Microsoft Office Suite.
- Exceptional communication, negotiation, and stakeholder management skills.