Clinical Project Manager, Clinical Operations
Clinical Project Manager, Clinical Operations
Replimune
Woburn, MA
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This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.
Responsibilities
Key responsibilities:
- Manage or assist in managing study execution, including management and oversight of CROs, vendors and consultants that are involved with the clinical trial.
- Contribute/establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
- Proactively identify risks, offer mitigation strategies and support implementation.
- Ensure trial adherence to ICH-GCP, Federal and local regulations and company specific SOPs.
- May oversee investigator recruitment/ selection across project.
- Ensure study staff is appropriately trained on relevant guidelines, regulations and SOPs.
- Participate in ad hoc clinical operations’ initiatives and programs.
- Contribute to preparation and review of clinical documentation such as Investigator Brochures, clinical protocols, informed consents, annual updates to regulatory authorities, and trial status updates.
- Contributes to the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, project management plans, communication plans, and quality plans
- Oversight of clinical monitoring to ensure that all outstanding site issues are closed out in a timely manner (if applicable).
- Participate in the forecasting of Investigational Medicinal Product and clinical trial related supplies.
- Tracks study progress ensuring timely data collection, monitoring and, in collaboration with data management, internal listings reviews
- Ensure that the Trial Master File (TMF) is set up and maintained throughout the trial in compliance with ICH/GCP and company SOPs, including conducting periodic risk based reviews to ensure all appropriate documents are filed.
- Assist with the development of the clinical components of regulatory submissions including, but not limited to safety, interim and final study reports.
- Participate/provide assistance with responding to Quality Assurance audits and/or regulatory authority inspections.
- Assist with ongoing study communication and escalation of study-related issues as required.
- Participates in meetings with investigator sites, key opinion leaders and consultants as needed.
- Facilitate the development of clinical trial agreements and other relevant documents.
- Contribute to request, creation and review of scope of work and budgets; participate in vendor performance management and issue resolution.
- Review and provide input for site budgets, manage clinical trial budget, providing ongoing financial reporting and projections to finance.
- Reconciliation and reporting for vendor and site invoices, payments and change orders, ensuring accuracy and timely delivery.
- Work cross-functionally to ensure clinical program timelines and goals are met.
- May participate in site visits, evaluating CROs/contract monitors through co-monitoring visits and/or site audits.
- May provide study-specific mentoring for junior team members, as appropriate.
- Participate in operational improvement initiatives (e.g. SOP development, training, etc.).
Educational requirements:
- Bachelor’s degree in health sciences or related field.
- Minimum of 5+ years’ experience in clinical research with at least 2 years’ experience in study management. Clinical Monitoring preferred.
- Experience in management of CROs, vendors and consultants.
- Documented training, knowledge and application of current FDA Regulations, ICH-GCP guidelines for clinical trials required.
- Proficient written and verbal communication skills.
- Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
- Therapeutic (oncology) or medical knowledge preferred.
- Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.
- Position may require some travel.
- This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Project Management and Information Technology -
Industries
Biotechnology Research
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