Clinical Research Unit (CRU) Operations Manager - Bali

Are you a seasoned Clinical Research Operations Leader ready to drive excellence in a dynamic, high-impact environment? Recruit Lync is seeking a CRU Operations Manager to oversee and optimize clinical research operations in Bali, Indonesia. Join us in our mission to deliver high-quality clinical trials, leveraging your expertise in clinical research operations to ensure seamless execution and compliance.

In this role, you will be responsible for managing the day-to-day operations of our Clinical Research Unit (CRU) in Bali. You will work closely with cross-functional teams, including clinical research associates, data managers, and regulatory affairs, to ensure that all clinical trials are conducted efficiently and in accordance with international standards.

This is a unique opportunity to work in a vibrant and growing market, contributing to the success of our global clinical research initiatives. With a competitive salary and a comprehensive benefits package, we offer the perfect environment for you to thrive and grow.

📋 Tanggung Jawab Pekerjaan

• Oversee the day-to-day operations of the Clinical Research Unit (CRU) in Bali, ensuring compliance with international clinical research standards.
• Manage and mentor a team of clinical research associates, data managers, and other support staff.
• Develop and implement operational protocols and procedures to ensure the smooth execution of clinical trials.
• Collaborate with cross-functional teams to ensure the timely and accurate collection, management, and reporting of clinical data.
• Monitor and analyze data to identify trends, issues, and opportunities for improvement.
• Ensure compliance with regulatory requirements and industry standards.
• Develop and maintain strong relationships with key stakeholders, including sponsors, investigators, and regulatory agencies.
• Participate in continuous quality improvement initiatives to enhance the efficiency and effectiveness of clinical research operations.

🎓 Kualifikasi & Syarat

• Bachelor's degree in a relevant field, such as Pharmacy, Medicine, or a related discipline.
• A minimum of 5 years of experience in clinical research operations, with a focus on site management and operations.
• Certification in clinical research operations (e.g., CROA, CQA) is a plus.
• Proficient in using clinical research software, such as Oracle Clinical, Medidata Rave, or similar systems.
• Strong knowledge of regulatory requirements, including ICH-GCP, FDA, and EMA guidelines.
• Excellent leadership and communication skills, with the ability to manage and mentor a diverse team.
• Proven track record of managing multiple clinical trials simultaneously.
• Ability to work in a fast-paced, dynamic environment with a high level of attention to detail.

🛠️ Keahlian

Lowongan Terkait