Senior Clinical Scientist, Early Development (BBBH446498) Neuchâtel, Suisse
For our client, a biopharmaceutical company localized in Switzerland in the Canton of Neuchâtel, we are looking for a:
Senior Clinical Scientist, Early Development
Temporary contract long duration – 100%
RESPONSIBILITIES
- Maintain a thorough understanding of assigned protocols and protocol requirements and educate team members.
- Plan and lead the implementation of clinical study startup/conduct/close-out activities as applicable.
- Evaluate innovative trial designs in collaboration with the study physician.
- Manage protocol and ICF development process with minimal guidance. Present to governance committee and early clinical development team meetings as required.
- Serve as primary contact for site-facing activities such as training and support for clinical questions.
- Conduct and oversee activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review.
- Identify clinical data trends; provide trends and escalate questions to study physician.
- Develop clinical narrative plan and review clinical narratives.
- Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
- Review/develop site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee activities.
- Collaborate and serve as primary liaison between external partners for scientific advice.
- Author/review abstracts, presentations, and manuscripts for external publications
PROFILE
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).
- 5+ years of experience in clinical science, clinical research, or equivalent.
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
- Excellent verbal, written, communication and interpersonal skills.