Sr. Clinical Trial Manager, Clinical Operations, Oncology/ Rare Disease (Lexington)

Employment Type

: Full-Time


: Scientific Research

Sr. Clinical Trial Manager, Clinical Operations, Oncology/ Rare Disease


Our client is looking for a Sr. Clinical Trial Manager to who will lead the planning and manage the implementation of early and late phase clinical research studies, including creating and managing study timelines, budgets and study management plans in a fully outsourced model.

This role provides oversight of Clinical Research Organizations (CROs) and other vendors and may author, review and approve various study related documents and plans. The CTM reports to the Head of Clinical Development Operations and offers the chance to join a team of passionate colleagues with the opportunity for career growth and interact across all levels of the organization and manage complex project timelines.

Duties / Expectations of Role

  • Manage the study team to design, develop, execute and deliver clinical studies in accordance with clinical development plans/strategy and timelines
  • Lead the evaluation, selection, and oversight of CROs and other external vendors to ensure successful clinical trial implementation and execution
  • Anticipate, recognize and resolve issues; as necessary, manage escalation of study related issues with management and other R&D functions
  • Contribute to the writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, monitoring plans, trial reports and DSURs
  • Review and approve study-related plans generated by CROs and vendors, and ensure the documentation is in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies
  • Ensure audit-ready condition of clinical trial documentation including the trial master file
  • Review monitoring reports to ensure quality and resolution of site-related issues
  • Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
  • Lead planning and conduct of investigators meetings
  • Monitor progress of clinical study activities and report on the progress of assigned clinical trials including budget and timelines
  • May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance
  • Manage Investigator Sponsored Trials
  • Participate in the preparation and review of SOPs

Mandatory Requirements

  • Bachelors degree is required. Scientific/health care field preferred, but not required.
  • Minimum of 5 years in clinical development in pharmaceutical/biotech industry, 2+ years of expertise in clinical trial management
  • Thorough knowledge of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally
  • Extensive experience managing complex protocols, CROs, budgets, and timelines
  • Experience monitoring clinical studies and conducting SQVs, SIVs, IMVs, and COVs preferred
  • Must be willing to travel both domestic and international
  • Strong verbal and written communication skills including clinical authoring experience
  • Ability to organize and manage multiple priorities in a fast-paced, entrepreneurial environment
  • Proven track record of effective leadership with excellent organizational skills and ability to work independently
  • Strong interpersonal skills to interact with investigators, vendors, and individuals at all levels of the organization

Terms & Start:

  • 6-12 month Contract to Hire
  • ASAP Start
  • Some travel may be required

Associated topics: biopharma, diet, healthcare, injury, medical, nutrition, pharmacometrics, transfection, trauma, virus

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