Clinical Operations Team & Trial Leader (100%)
Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on medical science and the development and commercialization of innovative pharmaceutical products for the treatment of rare neuromuscular diseases with high unmet medical need. For further information, please visit the Company's website www.santhera.com Come and join our team to contribute to providing treatment options for patients with rare diseases that have a severe impact on the lives of affected children and adults. You can make a difference as Clinical Operations Team & Trial Leader (100%) Location: HQ Pratteln, Switzerland Scope of Work
The Clinical Operations Team & Trial Leader provides operational guidance and oversight across clinical trials and leads assigned Clinical Operations team members. 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 the cross-functional Study Management Team (SMT), aligning efforts to common goals. The role reports to the Head Clinical Operations acting as the deputy and works in close collaboration with multiple functions, technical development & operations, regulatory affairs, clinical science, biostatistics and drug safety. Key Responsibilities
The Clinical Operations Team & Trial Leader provides operational guidance and oversight across clinical trials and leads assigned Clinical Operations team members. 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 the cross-functional Study Management Team (SMT), aligning efforts to common goals. The role reports to the Head Clinical Operations acting as the deputy and works in close collaboration with multiple functions, technical development & operations, regulatory affairs, clinical science, biostatistics and drug safety. Key Responsibilities
- Provide line management and inspirational leadership to assigned Clinical Operations team members.
- Give operational guidance and oversight across clinical trials including clinical operations related input to clinical development plans.
- Act as a Clinical Trial Leader executing 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.
- Coordinate and oversee pre-audit and CAPA resolution activities relevant for Clinical Operations.
- University or equivalent education/degree in life science or healthcare.
- 6+ years of experience in clinical development and clinical trial management; field monitoring experience is desired.
- Thorough understanding of the drug development process.
- Advanced knowledge of ICH-GCP guidelines and other relevant clinical trial regulations.
- Experience in external service providers management incl. selection.
- Profound project management experience and leadership skills.
- High financial acumen to manage clinical trial budgets.
- Fluency in English (any other language is a plus).
- Strong leadership skills acting comfortably in a matrix organization.
- Strong verbal and written communication and presentation skills.
- Ability to work independently to manage multiple projects in a fast-paced environment with a sense of urgency.
- Strong problem solving and analytical skills with a high attention to details.
- Well organized and structured work style ensuring accurate work results.
- Ability to identify opportunities / major issues and to communicate impact, excellent project management skills.
- Reliable team-player.
À propos de l'entreprise
Liestal / Pratteln / Basel area, Switzerland / Schweizerhalle
