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Clinical Scientist

Cambridge, MA

Posted: 07/15/2019 Employment Type: Direct Hire Job Category: Clinical: Scientific Job Number: 2359

Our client is adding to their Clinical Team and seeking a motivated and enthusiastic Clinical Scientist with experience in successfully executing on clinical programs in the oncology space.

Responsibilities:
  • Accountable for the writing of clinical protocols and related documents in collaboration with the Medical Director. Will include managing the protocol development process and contributing to the medical/scientific input for the development of trial-related documents.
  • Participate in development of effective working relationships with key investigators to ensure optimal clinical study design, execution, and reporting. Contribute to trial-related advisory boards. Assist in protocol training meetings and investigator meetings.
  • Work with Clinical Operations to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures: report study progress and issues with their resolution plan to Medical Director.
  • Lead in the process of reviewing, analyzing and interpreting of clinical trial data in collaboration with Medical Director. Includes the development of clinical trial reports, investigator brochures, publications and internal/external presentations.
  • Assist Clinical Operations in the development of clinical outsourcing specifications to facilitate bid templates and selection of CROs.
  • Contribute to the development of clinical sections of regulatory documents such as briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
  • Lead review of clinical trial documents such as statistical analysis plans, case report forms, etc.

Requirements:
  • Minimum of 5 years operational experience in planning, executing, and reporting clinical studies.
  • Advanced knowledge of Oncology and/or Hematology is strongly preferred.
  • Proven ability to work independently as well as to contribute to a multidisciplinary trial team.
  • Experience in developing effective relationships with key investigators and their staff.
  • Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory processes.
  • Advanced degree or equivalent education; degree in life science/healthcare is strongly recommended; PharmD, PhD preferred.
  • Some travel required.

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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