Senior Clinical Scientist, Early Development

12 May | Temporary | 100%

Senior Clinical Scientist, Early Development

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.

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