Clinical Trial Manager (CTM) - Permanent/FTE
Clinical Trial Manager
Location: Redwood City
Seeking a full-time Clinical Trial Manager (CTM) to join our collaborative team. This individual, reporting to the Senior Director of Clinical Development.
Contribute to the team's production of important study documents, ranging from training manuals to protocols to various study-specific plans. Perform systematic QC review and, where applicable, writing of designated or operational sections of these deliverables. Develop and update standard company procedures related to trial and clinical sample management.
Partner with contract research organizations (CROs) in identifying potential study sites and assessing feasibility. Oversee completion of site selection visits conducted by CROs by reviewing finalized reports and participating in evaluating them.
Take an operational leadership role in organizing site initiation visits (SIVs), investigator meetings (IMs), and other engagements, including preparation and/or delivery of presentations for sites, CROs, and other attending stakeholders.
Serve as primary point of sponsor contact for investigators, study coordinators, IRBs, ethics committees, CROs, site-facing vendors, and other stakeholders leading up to, during, and after closeout of studies.
Actively track overall study metrics and individual subject data (e.g., critical sample collections, visit adherence), providing status updates to the team. Monitor study timelines, working cross-functionally with Project Management in doing so.
Oversee CRO monitoring of study-related documentation and activities at sites, both remotely and via periodic in-person oversight visits conducted in parallel with scheduled site monitoring visits by CRO CRA, to ensure adherence to Good Clinical Practice (GCP) guidelines, protocols, monitoring plans, regulatory requirements, and relevant standard operating procedures (SOPs). Oversee and prepare corresponding reports to be provided to the team as requested.
Review incoming clinical trial data. Collaborate with Clinical Development and, if applicable, Clinical Data Management team members on resolving data queries with sites and CROs, followed by coordination of locking of the trial database.
Contribute to clinical study report preparation, including review of tables, figures, and listings for accuracy and completeness, in collaboration with team members from other functions.
Develop, maintain, and regularly evaluate company relationships with site-facing vendors, including central clinical laboratories, CROs, and carriers providing shipment of IP and supplies to sites.
Monitor and update study data on clinicaltrials.gov, EU Clinical Trials Register, and analogous electronic trial databases.
Compile and maintain trial master files (TMFs) for ongoing studies, in conjunction with on-site CRO team members.
Build rapport with and motivate sites to adhere to study timelines in achieving study milestones. Contribute to development and rollout of strategies to enhance study enrollment, where needed.
Be responsible for execution and tracking of confidentiality agreements with collaborators and other stakeholders.
Work closely with other functions (e.g., Regulatory, Clin. Develop.) on preparing documents for regulatory submissions.
Be available to assist, if needed, with tracking study contracts, invoicing, payments, and budgets across vendors and sites.
Take on additional responsibilities and grow into new roles that will evolve in parallel with ongoing clinical development.
At minimum, Bachelor's Degree (BS, BA) in life sciences, nursing or health-related field, or equivalent.
At least 5 years cumulative postgraduate experience as CRA, Senior CRA, and/or CTM/CPM monitoring/managing clinical trials at a CRO and/or within pharmaceutical/biotech industries. Experience in Clinical Operations spanning the full spectrum of study progress, from site selection to startup to closeout, is required. Preference is for a candidate with experience across the early and late phases of clinical development.
Solid understanding of GCP, U.S. FDA, and international/ICH guidelines pertaining to the drug development process and conduct of clinical studies. Proficiency applying these guidelines to ensure that internal and external (i.e., site-generated) trial documentation meets these standards.
Job Type: Direct Placement
Location: Redwood City, CA
Job ID: 20-04946
Date Updated: July 24, 2020