Associate Director Of Clinical Operations

Location: Boston, Massachusetts, United States
Salary: negotiable
Job Type: Permanent
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Associate Director of Clinical Operations

Our client is seeking an experienced Clinical Operations professional to join their growing Clinical Development Organization. This role will be key to leading the planning, execution and oversight of clinical trials in Oncology.

This position will also have the opportunity to help develop Clinical Operations processes and procedures for a growing department. Representing clinical operations on the program team, this role is responsible for adhering to timelines and milestones of study goals as well as identifying and communicating risks to the team.

Responsibilities

  • Participates in authoring IND and study documents including protocols, IB, ICF pharmacy, lab and other study and program related manuals.
  • In partnership with regulatory affairs and quality, participates in global study submissions as well as oversight of additional resources needed (including QP readiness, document translations, etc.).
  • Representing clinical operations on the program team, provides overall status updates, escalates issues and presents on risk mitigation strategies to the cross-functional team
  • Lead in the selection and oversight of CROs and other vendors
  • Ensures appropriate oversight of CROs and other external vendors, including assessment of performance against contractual obligations
  • Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
  • Develops close relationships with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
  • Develop and maintain tracking tools for clinical trials including study and monitoring visits, sample tracking, data entry and action item progress
  • Partners with Clinical Supply and Technical Operations to oversee drug supply of the applicable study drug(s). This includes participating in long range supply planning for trials within the oncology program
  • Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans)
  • Performs quality assurance checks (e.g. reviewing protocols for operational effectiveness, monitoring trip reports, conducting co-monitoring visits at clinical sites as needed, reviewing data listings or profiles at specified timepoints)

Qualifications & Education

  • Bachelor's degree (scientific or healthcare discipline preferred) plus at least 5+ years in clinical operations or drug development
  • Proven experience in the oversight of the operational aspects of all stages of clinical studies
  • Experience and familiarity with operating clinical trials outside the US
  • Extensive experience managing complex protocols
  • Prior experience managing Oncology trials
  • Experience with cell therapy will be favorably considered
  • Knowledge of ICH GCP
  • Excellent organizational as well as problem-solving skills as well as the ability to work independently
  • Ability to work in a fast pace, cross-functional, start-up environment

If you or a CTM/AD you know feel this could be an opportunity you would like to explore please send me your most up to date resume at c.hesler (at sign) Realstaffing.com to discuss the role in further detail.

Sthree US is acting as an Employment Agency in relation to this vacancy.

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