- 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.
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Senior Clinical Trial Manager - California, United States - BioPhase
Description
BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Life Sciences community. We are currently looking for an ONSITE Sr. Clinical Trial Manager to work for a leading San Diego area biotech company.
*Must be local to San Diego, CA.
Key Responsibilities:
· Oversee the performance of CROs and third-party vendors, including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Clinical Operations Managers.
· Perform initial review of CRO and other third-party study vendor invoices for correctness.
· Develop and maintain good working relationships with CRO, 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 coordinate site training, product delivery, supply 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 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; coordinates 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:
*Travel requirement up to 30%
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 and let's make work better
