Clinical Operations Manager (COM)/Sr. COM
We are seeking an energetic and highly motivated individual to join our Clinical Operations team. Reporting to the Head of Clinical Operations the Clinical Operations Manager (COM)/Sr. COM will be empowered to lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s).
- 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.
Experience and Qualifications:
- BS/BA Degree or equivalent in science or a health related field is preferred.
- iMinimum of 5-10 years of relevant industry clinical development experience, particularly in clinical trial management with at least 3 years of clinical trial execution at a pharmaceutical company, biotech company, and/or CRO.
- Oncology experience preferred.
- 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.
- 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]