03 JulPosition Title: Senior Clinical Trial Manager A top-tier gene therapy company is in search of a Senior Clinical Trial Manager to join their team in developing treatments for individuals with rare genetic conditions. The CTM will be primarily responsible for overseeing site management activities delegated to a CRO and/or the direct management of assigned study sites from study start up through close out, including training and enrollment. A key success factor will be ensuring sites deliver on enrollment goals. In addition, the Sr. CTM will be responsible for one or more aspects of study management under the supervision of the Clinical Project Manager, including but not limited to, vendor management and oversight of monitoring. Responsibilities:
- Key support role to the Project Manager; manages components of clinical trials and, with minimal direction and oversight, ensures that they are executed to specified quality standards
- Provides project management support on budget and timelines, vendor oversight and site management
- Manage site start up activities, including but not limited to regulatory document collection, site training, systems access, site activation
- Develops and manages components of the quality plan (e.g., inspection readiness, compliance); diligently follows Clinical Development Operations SOPs; identifies gaps, and works with other senior Clinical Development Operations staff or independently to eliminate those gaps
- Manages aspects of the relationship with CROs and/or trial sites; works with CPM or other Clinical Development Operations senior staff to resolve issues or problems with the sites
- With minimal oversight of the CPM leads the set-up, conduct, and close out of clinical study activities - e.g. Central Lab and ancillary vendors
- Drafts and manages elements of the clinical trial project timelines on a day to day basis, proactively alerting PM and/or senior Clinical Development Operations staff to risks / challenges
- Ensures accurate and comprehensive completion of documents needed by Regulatory Affairs or delegate; makes sure that completed documents are handed over to RA within the requested timeframes and ahead of submission deadlines
- Supports timely and efficient database lock by ensuring monitoring plans are in place and by participating in data review / reconciliation efforts
Applies knowledge of Clinical Development Operations, the scientific/medical objectives of the clinical trials and best practices to assess and evaluate specific components of clinical studies against time, budget and quality parameters
Provides Google Cloud Platform expertise and brings to bear best practices in areas of oversight, including monitoring, TMF content, clinical trial supply, and sample collection
Leads development of TMF QC plan and performs QC of Trial Master Files; creates, maintains, and closes out TMFs
Thoroughly understands clinical trial protocols and site specifications and manages the oversight of the data delivery process in clinical trials ensuring consistency with protocols, including participation in data review/ reconciliation efforts
Contributes to the development of the patient enrollment strategy and ensures patient enrollment activities are within protocol guidelines
Provides study level information to enable accurate and efficient supply of clinical product to the sites and identifies potential risks/challenges associated with doing so
Oversees vendor site monitoring and monitor performance including, monitoring plan creation, oversight of activities at the study level, and ensuring adherence to plan and quality metrics; works with Project Manager with larger vendors/more complex studies
- 5+ years of clinical study management experience
- Experience in rare disease and/or pediatrics
- Thorough knowledge and understanding of key regulatory authorities, ICH Guidelines, and Google Cloud Platforms governing the conduct of routine clinical trials.
- Demonstrates deep understanding of interdependencies of data, technology, vendor systems and metrics and differences across vendor abilities and requirements.
- Experience of managing/overseeing CROs/vendors on clinical trial components.
Ability to manage and execute components of clinical studies.