- This role focuses on the efficient and compliant initiation of Client-sponsored clinical trials by developing and implementing effective start-up strategies, overseeing start-up operations, and driving process improvements at the country and site level while maintaining regulatory compliance.
Key responsibilities include:
- Leading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.
- Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance.
- Ensuring alignment with global strategies and timelines.
- Managing amendments throughout the study lifecycle.
- Identifying and driving opportunities for process automation, standardization, and innovation.
- Collaborating with regional and global counterparts to harmonize systems and improve timelines.
- Participating in external industry collaborations to influence country start-up environments.
- Engaging with government and institutional bodies to align on clinical trial policies and practices (e.g.,
with Ethics Boards, Health Authorities).
Skills and Qualifications:
- Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent. Postgraduate degree or master’s degree highly desirable
- Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration
- Strong understanding of ICH-GCP, EU CTR, and local regulatory environments
- Experience managing vendor/CRO relationships
Mandatory Skills Required:
- Excellent communication and interpersonal skills
- Strong organizational, analytical, and problem-solving capabilities
- Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.)
- Cooperative and adaptable mindset with attention to detail
- Ability to lead through complexity and ambiguity, especially in matrixed and global teams
- Fluency in written and spoken English is mandatory.
- Fluency in written and spoken language(s) of the host country is mandatory.