job description
Are you a dynamic Clinical Research Project Manager with a passion for advancing medical science through meticulously managed clinical studies? JobStudio is seeking a proactive professional to lead and coordinate clinical research projects in a Clinical Research Unit (CRU) environment in beautiful Bali, Indonesia.
In this pivotal role, you will oversee the planning, execution, and monitoring of clinical trials, ensuring compliance with regulatory standards and ethical guidelines. Your expertise will drive the success of groundbreaking research initiatives, contributing to global healthcare advancements. Bali’s vibrant culture and serene landscapes provide an inspiring backdrop for this impactful career opportunity.
If you thrive in a collaborative, fast-paced setting and are committed to excellence in clinical research, we invite you to apply and become part of a team dedicated to innovation and patient-centric solutions.
Responsibility
- Lead the planning, coordination, and execution of clinical research projects in a CRU environment.
- Ensure compliance with ICH-GCP guidelines, local regulations, and ethical standards.
- Develop and manage project timelines, budgets, and resource allocation.
- Collaborate with cross-functional teams, including investigators, sponsors, and regulatory bodies.
- Monitor study progress, identify risks, and implement mitigation strategies.
- Prepare and review clinical study protocols, informed consent forms, and other essential documentation.
- Oversee data collection, analysis, and reporting to ensure accuracy and integrity.
- Serve as the primary point of contact for stakeholders, providing updates and resolving issues.
Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Medicine, Pharmacy, or related fields.
- Minimum 5 years of experience in clinical research, with at least 2 years in a project management role.
- Proven track record of managing Phase I-IV clinical trials in a CRU or similar setting.
- In-depth knowledge of ICH-GCP, FDA, and local regulatory requirements.
- Strong leadership, organizational, and problem-solving skills.
- Excellent communication and interpersonal abilities to liaise with diverse stakeholders.
- Proficiency in clinical trial management systems (CTMS) and Microsoft Office Suite.
- Certification in Clinical Research (e.g., CCRP, PMP) is a plus.