Clinical Trial Manager - Bangka Belitung

Join PT Global Pharma Innovations, a leader in clinical research, as a Clinical Trial Manager in the dynamic region of Bangka Belitung. You will oversee end-to-end clinical trial operations, ensuring compliance with ICH-GCP, local regulations, and ethical standards. This role offers a unique opportunity to contribute to groundbreaking research while enjoying a high standard of living in a developing region.

As a Clinical Trial Manager, you will lead a team of clinical research professionals, from site initiation to trial completion. You will be responsible for managing budgets, timelines, and quality assurance, while ensuring all trials are conducted with the highest level of integrity and efficiency. With PT Global Pharma Innovations, you will have access to state-of-the-art facilities and resources, as well as ongoing training and development opportunities.

📋 Tanggung Jawab Pekerjaan

• Oversee end-to-end clinical trial operations, ensuring compliance with ICH-GCP and local regulations.
• Lead and mentor a team of clinical research professionals, including site managers and coordinators.
• Manage budgets, timelines, and quality assurance for clinical trials.
• Conduct site inspections and audits to ensure adherence to trial protocols and standards.
• Collaborate with cross-functional teams, including regulatory affairs, data management, and medical writing.
• Ensure ethical conduct and patient safety throughout all clinical trials.
• Provide strategic guidance to site teams, including training and support.
• Prepare and submit regulatory submissions, including investigational new drug (IND) applications and trial master files.

🎓 Kualifikasi & Syarat

• Bachelor's degree in Pharmacy, Medicine, Public Health, or a related field.
• Minimum 10 years of experience in clinical research, with at least 5 years in a management role.
• Certification in Clinical Research Coordinating (CRC) or Clinical Research Associate (CRA) is a plus.
• Proven experience in managing multi-site clinical trials.
• Strong understanding of ICH-GCP guidelines and local regulatory requirements.
• Excellent leadership and communication skills.
• Proficiency in English, both written and spoken.
• Experience with clinical trial management software such as eTMF, Medidata Rave, or OpenClinica is a plus.

🛠️ Keahlian

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