job description
Join a leading public healthcare organization in Bali as a Clinical Affairs Manager and play a pivotal role in shaping clinical strategies and ensuring compliance with regulatory standards. This is a unique opportunity to work in a dynamic environment, collaborating with cross-functional teams to drive excellence in healthcare delivery.
As a Clinical Affairs Manager, you will oversee clinical trials, manage regulatory submissions, and ensure adherence to ethical and legal guidelines. Your expertise will contribute to the development of innovative healthcare solutions that improve patient outcomes.
Based in the vibrant regions of Bali, including Canggu, Ubud, and Denpasar, this role offers a competitive salary, professional growth, and the chance to make a meaningful impact in the healthcare sector.
Responsibility
- Lead and manage clinical trials, ensuring compliance with regulatory requirements and ethical standards.
- Develop and implement clinical strategies to support product development and market approval.
- Collaborate with cross-functional teams, including R&D, regulatory affairs, and medical teams, to ensure alignment with clinical objectives.
- Oversee the preparation and submission of clinical documentation to regulatory authorities.
- Monitor and evaluate clinical trial progress, ensuring adherence to timelines and budgets.
- Provide training and guidance to clinical staff on best practices and regulatory compliance.
- Analyze clinical data and prepare reports for internal and external stakeholders.
- Stay updated on industry trends, regulatory changes, and advancements in clinical research.
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience in clinical affairs, clinical research, or a related role within the healthcare industry.
- Strong knowledge of regulatory requirements, including GCP, ICH, and local healthcare regulations.
- Proven experience in managing clinical trials and regulatory submissions.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.
- Analytical mindset with strong problem-solving and decision-making abilities.
- Proficiency in clinical data management systems and Microsoft Office Suite.
- Fluency in English; knowledge of Indonesian is a plus.