Clinical Research Executive - Bangka Belitung

Join PT Medika Nusantara Research, a leading clinical research organization in Indonesia, as a Clinical Research Executive in the vibrant region of Bangka Belitung. This is a unique opportunity to drive cutting-edge medical research, ensuring compliance with international standards and contributing to groundbreaking medical advancements. In this role, you'll be part of a dynamic team, collaborating with researchers, clinicians, and regulatory bodies to bring innovative treatments to market.

As a Clinical Research Executive at PT Medika Nusantara Research, you'll be responsible for managing clinical trials from initiation to completion. You'll work closely with a multidisciplinary team, including clinical research associates, data managers, and regulatory affairs specialists, to ensure the successful execution of clinical trials. Your day-to-day tasks will include coordinating study activities, monitoring trial progress, and ensuring adherence to ethical and regulatory guidelines.

📋 Tanggung Jawab Pekerjaan

• Manage clinical trials from initiation to completion, ensuring compliance with international standards such as ICH-GCP and ICMJE.
• Coordinate with a multidisciplinary team to plan, execute, and monitor clinical trials.
• Develop and maintain study documentation, including protocols, case report forms, and patient information sheets.
• Monitor trial progress, identify and mitigate risks, and ensure timely resolution of any issues.
• Conduct site visits and audits to ensure adherence to study protocols and regulatory requirements.
• Collaborate with regulatory affairs specialists to ensure compliance with local and international regulations.
• Provide training and support to clinical research associates and site personnel.
• Prepare and present reports to stakeholders, including sponsors, regulatory authorities, and investors.

🎓 Kualifikasi & Syarat

• Bachelor's degree in Pharmacy, Medicine, Public Health, or a related field.
• 5-7 years of experience in clinical research, with a strong background in clinical trial management.
• Certification in Good Clinical Practice (GCP) or equivalent.
• Proficiency in clinical research software, such as Oracle Clinical, Medidata Rave, or similar.
• Strong understanding of regulatory requirements, including ICH-GCP and ICMJE.
• Excellent communication and interpersonal skills, with the ability to work effectively with a multidisciplinary team.
• Ability to manage multiple projects simultaneously and meet tight deadlines.
• Familiarity with the Indonesian regulatory environment and local clinical research standards.

🛠️ Keahlian

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