job description
Are you a seasoned clinical research professional with a passion for leading high-impact projects in a dynamic environment? JobStudio is seeking a Senior Clinical Research Project Operations Manager to oversee and drive the execution of clinical studies within our fast-paced Clinical Research Unit (CRU) or early-phase research setting. This is a unique opportunity to lead cross-functional teams, ensure operational excellence, and contribute to groundbreaking medical advancements.
Based in the vibrant regions of Bali, including Canggu, Ubud, Denpasar, and more, you will play a pivotal role in shaping the future of clinical research. If you thrive in a collaborative, innovative, and results-driven environment, we want to hear from you!
At JobStudio, we are committed to fostering a culture of excellence, integrity, and continuous learning. Join us and be part of a team that is making a real difference in healthcare.
Responsibility
- Lead and manage the operational execution of clinical research projects from initiation to completion, ensuring adherence to timelines, budgets, and regulatory standards.
- Oversee cross-functional teams, including clinical researchers, data managers, and regulatory affairs specialists, to ensure seamless project delivery.
- Develop and implement project plans, risk management strategies, and contingency plans to mitigate potential challenges.
- Collaborate with stakeholders, including sponsors, investigators, and ethical review boards, to ensure compliance with protocols and regulatory requirements.
- Monitor project progress, identify bottlenecks, and implement corrective actions to keep projects on track.
- Ensure the accurate and timely collection, analysis, and reporting of clinical data in accordance with Good Clinical Practice (GCP) guidelines.
- Provide leadership and mentorship to junior team members, fostering a culture of continuous improvement and professional development.
- Contribute to the development of standard operating procedures (SOPs) and best practices to enhance operational efficiency.
Qualifications
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree (Master's or PhD) is a plus.
- Minimum of 5 years of experience in clinical research, with at least 3 years in a project management or operational leadership role.
- Proven experience leading teams in the execution of clinical studies within a CRU or early-phase research environment.
- Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements for clinical trials.
- Excellent organizational, communication, and interpersonal skills, with the ability to manage multiple priorities in a fast-paced environment.
- Experience with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Certification in project management (e.g., PMP) or clinical research (e.g., CCRP, CCRA) is highly desirable.
- Ability to work effectively in a multicultural and multidisciplinary team environment.