Senior Clinical Operations Manager

We are seeking an energetic and highly motivated individual to join our Clinical Operations team. Reporting to the Head of Clinical Operations the Senior Clinical Operations Manager will be empowered to lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s).

Responsibilities

  • Collaborate with the Medical Director and cross functional teams on the development, planning, and execution of the clinical trial operations strategy for assigned clinical trial(s).
  • Coordinate and contribute to the development of critical study documents including Clinical Protocols, Investigator’s Brochures, ICFs, annual updates to regulatory authorities and responses to questions from IRBs and Ethics Committees.
  • Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
  • Manage and provide documented oversight of CRO and other 3rd party vendors to ensure compliance with the study protocol and overall clinical objectives.
  • Lead and manage day-to-day execution of assigned clinical trial(s) to ensure all trial deliverables are met according to established timelines, budget, and quality standards.
  • Coordinate and lead cross functional study team meetings.
  • Maintain primary responsibility for the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, clinical monitoring plans, trial operational plans, and regulatory plans.
  • Ensure effective clinical and safety data review plans are developed and followed throughout the study.
  • Develop strong relationships with Investigators, site staff, and CRO partners.
  • Responsible for the development and management of budget for assigned clinical trial(s); provide ongoing reporting and forecasting to finance.
  • Willing to travel at least 25% of time to maintain relationships with trial sites and attend vendor meetings as needed

Requirements:

  • BS/BA Degree or equivalent in science or a health-related field is preferred.
  • Minimum of 7-12 years of relevant industry clinical operations experience, particularly in clinical trial management with at least 5 years of clinical trial execution at a pharmaceutical company, biotech company, and/or CRO.
  • Oncology or Inflammatory Disease experience required.
  • Experience with managing and demonstrating oversight of CROs, vendors, and consultants.
  • Extensive knowledge and application of current FDA Regulations, ICH/GCP guidelines in clinical trials.
  • Working knowledge of current global regulatory requirements and guidelines for clinical trials.
  • Ability to collaborate effectively with cross functional team members and external partners.
  • Strong experience facilitating project team meetings, cross-functional team communication and decision making and ensuring alignment with stakeholders.
  • Familiarity with clinical data review and data management processes.
  • Experience with SOP review and development.
  • Experience managing ex-USA trials.
  • Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook, and MS Project.

If you are interested in joining Ribon’s team, please email your resume to [email protected]

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