Senior Clinical Trial Manager
4 hours ago
BioPhase Solutions is seeking a highly skilled Clinical Trials Manager to join our team in San Diego, CA. As a key member of our clinical operations team, you will be responsible for overseeing the performance of CROs and third-party vendors, ensuring compliance with study protocol and regulatory requirements.
Key Responsibilities:
- Oversee the performance of CROs and third-party vendors, including co-monitoring, to ensure compliance with study protocol and regulatory requirements.
- Perform initial review of CRO and other third-party study vendor invoices for correctness.
- Develop and maintain good working relationships with CROs, investigators, and study staff.
- Perform clinical data review of data listings and summary tables, including query generation.
- Assist with third-party vendor training on protocols and practices.
- Coordinate the logistics of product readiness with sites and internally.
- Work cross-functionally with product manufacturing, QA, and supply chain management to ensure readiness and product availability prior to patient treatment.
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
- Ensure timely response to queries and monitoring discrepancies.
- Plan and conduct investigator meetings as directed.
- Manage the investigational product (IP) and non-IP study drug accountability and reconciliation process.
- Review and/or approve IP release packages.
- Review key study quality metrics (e.g., patient eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with the study team.
- Prepare and/or review study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, CRF Completion Guidelines, etc.).
- Track and report on current progress of the study, including site activation, patient enrollment, monitoring visits, and data submission backlogs.
- Contribute to the preparation of clinical protocols, amendments, informed consent forms, study manuals and guides, electronic case report forms, and any other clinical research-related documents.
- Participate in the planning of QA activities, coordinating the resolution of applicable audit findings.
- Ensure audit-ready condition of clinical trial documentation, including central clinical files; review monitoring visit reports to ensure quality and resolution of site-related issues; coordinate and assist in the planning of regulatory or ethics committee activities, as appropriate.
- Prepare/review site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
- Manage clinical monitoring activities (including approval of visit report templates, monitoring plan, etc.) ensuring compliance with ICH/GCP and applicable regulations, including the management through resolution (e.g., CAPA) of any site or study level issues, deviations, etc.
- Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.
- Collaborate with cross-functional teams (e.g., Medical Monitor, Regulatory Affairs, CRO, vendors, and Investigators/site staff).
Education/Experience Requirements:
- Bachelor's in Life Sciences or equivalent. Graduate degree preferred.
- Therapeutic experience in autoimmunity is strongly preferred.
- Proven experience in early phase clinical trials.
- Thorough knowledge of clinical research concepts, practices, FDA regulations, and ICH guidelines regarding drug development and data management methods.
- 5 or more years' experience managing clinical trials as the sponsor is preferred; prior working experience at a site or in a CRO is a plus.
- Strong site management and CRO management skills required.
- Experience monitoring sites and conducting other site management activities.
What We Offer:
As we work to develop innovations that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
· Full support and career-development resources to help you reach your potential.
· A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
Apply Now:
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