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Clinical Trial Manager, Ophthalmology
Ref No.: 18-01035
Location: Waltham, Massachusetts
Position Type:Direct Placement
Position: Clinical Trial Manager, Ophthalmology
Reports to: Associate Director, Clinical Operations
Location: Waltham, MA
Description: The Clinical Trial Manager is accountable for the management of one or more clinical trials including trial start-up, conduct, and close-out activities. Will lead one or more Study Management Teams.
Job Responsibilities:
  • Ensure trial adherence to ICH/GCP/local regulations.
  • Develop study plan(s) including key milestones and timelines.
  • Ensure country and site selection meet study requirements.
  • Develop and manage clinical trial budgets.
  • Ensure accuracy and timeliness of vendor and site payments.
  • Vendor identification and management (e.g., CROs, IVRS, Reading Centers, etc); including participating in negotiation of vendor scope of work, budgets, performance management, issue resolution, and quality assessments.
  • Ensure availability of clinical/non-clinical supplies.
  • Provide input for clinical regulatory documents (IB, CSR, IND updates).
  • Participate in development and testing of clinical systems (laboratory, data entry, IVRS, etc).
  • Ensure internal and external systems are updated in a timely manner (CTMS,
  • Maintain and oversee the Trial Master File.
  • Author/co-author protocols in collaboration with Medical Monitor and other stakeholders.
  • Identify, address, and communicate quality and compliance concerns.
  • Ensure inspection readiness internally and externally.
  • Provides regular study status updates and as requested.
  • Communicate effectively with internal and external study personnel (investigative staff, vendors, etc).
  • Provide study-specific direction, mentoring, and management to other staff as appropriate.
  • Manage direct reports as assigned.
  • Other duties and responsibilities as required.
Experience and Background:
  • Bachelor's Degree required.
  • Experience in ophthalmology required.
  • Experience assisting in clinical trials.
  • Knowledge of GCP and ICH.
  • Experience developing study plans and budgets including risk mitigation strategies.
  • Experience in multiple phases of research preferred.
  • Applicants must be authorized to work in the U.S.
  • Excellent verbal and written communication skills.
  • Experience in a start-up environment preferred.
  • Must be pro-active team player, flexible, and open to change