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Clinical Research Lead/Clinical Scientist

Cambridge, MA

Posted: 09/25/2020 Employment Type: Direct Hire Job Category: Clinical: Scientific Job Number: 2605

Job Description

Our client' s Clinical Team is growing and they are seeking a motivated and enthusiastic clinical scientist with experience in successfully executing on clinical programs in the oncology space.

How you will spend your day:
  • 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. 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.

Key things about you:
  • You have a minimum of 5 years' operational/clinical science l experience in planning, executing, and reporting clinical studies.
  • Advanced degree or equivalent education; degree in life science/healthcare is strongly recommended; PharmD, PhD preferred.
  • Advanced knowledge of Oncology and/or Hematology is strongly preferred.
  • You are able 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.
  • Ability to exercise judgment and address complex problems and create solutions.
  • Ability to work well and lead a cross-functional team.
  • Some travel required.

Meet Your Recruiter

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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