Senior Clinical Trial & Team Leader
The Senior Clinical Trial & Team Leader provides strategic guidance and oversight across clinical trials and leads the Clinical Operations team. Acting as a Clinical Trial Leader, this role plans clinical trials in accordance with company strategy and ensures their compliant and timely execution to final study report within budget. This role leads cross-functional Study Management Teams (SMTs), aligning efforts to common goals. The role reports to the Head of Development and works in close collaboration with multiple functions such as technical development & operations, regulatory affairs, clinical science, biostatistics and drug safety & pharmacovigilance. Key Responsibilities
- Provide line management and inspirational leadership to the Clinical Operations team.
- Provide clinical operations related input to clinical development plans and give guidance to implement the best strategy to meet clinical operations demand, in line with the company program.
- Build on, revise and/or adapt as required existing procedures, provide expertise and guidance to the clinical operations team to ensure that industry standard best-practices are met.
- Act as a Clinical Trial Leader executing assigned clinical trials from planning to final study report.
- Development and approval of study documentation, management of study approval process.
- Identification and selection of external service providers ensuring GCP compliant contracts.
- Coordination and oversight of pre-audit and CAPA resolution activities relevant for Clinical Operations.
- University or equivalent education/degree in life science or healthcare.
- 8+ years of experience in clinical development including the management of complex, global, & various stage clinical trials and external service providers; field monitoring experience is desired.
- Line management experience.
- Thorough understanding of the drug development process and advanced knowledge of ICH-GCP guidelines and other relevant international trial regulations.
- Strong financial acumen.
- Strong leadership skills and ability to motivate people.
- Ability to work independently to manage multiple projects in a fast-paced environment with a sense of urgency.
- Fluent in English (additional languages advantageous) and excellent presentation and communication skills to audiences at all levels.
- Pro-active and strong problem-solving attitude with a high attention to details.
- Ability to identify opportunities / major issues and to communicate impact, excellent project management skills.
Liestal / Pratteln / Basel area, Switzerland / Schweizerhalle