Senior Clinical Trial Manager
2 weeks ago
Must be located in San Diego, CA | willing to work onsite
The Senior Clinical Trials Manager is responsible for oversight and execution of the operational aspects of one or more clinical studies from protocol development through database lock. Ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations and guidelines governing the conduct of clinical trials.
Responsibilities:
· Assist with third-party vendor training on protocols and practices. 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.
· Developing and maintaining good working relationships with CRO, investigators and study staff.
· 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.
· Manage the investigational product (IP) and non-IP study drug accountability and reconciliation process.
· 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 clinical data review of data listings and summary tables, including query generation.
· Perform initial review of CRO and other third-party study vendor invoices for correctness.
· Plan and conduct investigator meetings as directed.
· Review key study quality metrics (e.g. patient eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.
· Review and/or approve IP release packages.
· 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 quality assurance 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 and/or review study-related documents.
· Prepare/review site study documents.
· 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.
Requirements:
· Undergraduate degree in life sciences or relevant work experience. Graduate degree preferred.
· Therapeutic experience in autoimmunity is strongly preferred.
· Five 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.
· Thorough knowledge of clinical research concepts, practices, FDA regulations and ICH guidelines regarding drug development and data management methods.
· Experience monitoring sites and conducting other site management activities.
· Ability to work in a fast-paced environment and flexibility
· Proven experience in early phase clinical trials.
· Strong site management and CRO management skills required.
· Proven communicator, both oral and written.
· Travel up to 30%
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