Senior Clinical Scientist

05 May | Temporary | 100%

Senior Clinical Scientist

Kelly Scientific is looking for an Senior Clinical Scientist for its pharmaceutical partner based in the Neuchatel canton.
(long term temporary position)

Missions:

  • You will provide scientific expertise necessary to design and deliver clinical studies and programs.
  • You will be responsible for implementation, planning, and execution of assigned clinical trial activities.
  • You will successfully lead, plan, and execute trial level activities for multiple trials with minimal to moderate level of supervision.
  • You will provide scientific and clinical leadership to clinical scientists on study team (matrix leadership).
  • You may support clinical development planning in collaboration with Early Clinical Development physician(s).


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 (e.g., documents and amendments) with minimal guidance; includes writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality in collaboration with Medical Writing. 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 (e.g., safety review) activities.
  • Author/review clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses).
  • 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, Master or similar scientific field preferred).
  • Min of 5 years of experience in clinical science, clinical research, or equivalent.
  • Good 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.
  • Must be able to effectively communicate and collaborate across functions and job levels.
  • Ability to assimilate technical information quickly.
  • Routinely takes initiative.
  • Proficient in Medical Terminology and medical writing skills.
  • Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile).
  • Proficient critical thinking, problem solving, decision making skills.
  • Willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
  • Proficient planning/project management skills
  • Travel Required Domestic and international travel may be required (approximately 10-25%)


Your contact at Kelly:
Mrs Karine Legerot
Consultant Professional Staffing Life Science
Kelly Scientific Geneva

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