The Senior Clinical Trial Manager will be responsible for managing clinical trial sites from study startup throughout the course of the clinical trials until site close out. They will work to oversee that all aspects of the conduct of the trial sites and or across their assigned assets are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. They will work collaboratively with the Sponsor Clinical Project Manager (CPM), Clinical Research Organization (CRO) representative(s), vendors and other Sponsor functional departments (as required) to drive start-up and ongoing oversight of clinical studies. They may have direct reports of Clinical Trial Managers across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost and quality.
Participate in the planning, implementation and management of sponsor clinical trials/assets in compliance with industry regulations, ICH-GCP and applicable sponsor controlled documents.
Oversee the site management of CROs and clinical trial sites to ensure delivery, per scope of work or contractual agreements, meet recruitment targets and deliver high quality data on time.
data quality concerns and site level trending of protocol deviations.
Conduct oversight site visits including pharmacy visits, as required, to evaluate site and CRA performance and ensure adherence to study protocols, study operation plans, ICH GCP and regulatory requirements
Attend and assist, as required, at Initiation visits to confirm site training of therapeutic indication(s) and associated study procedures (e.g. Pharmacy training) and help build and foster sponsor-CRO-Investigator - site relationships
Review a percentage of CRA monitoring trip reports, ensuring oversight of CRO CRA and Site compliance with protocol, study plans, SOPs and ICH and GCPs, escalate identified report issues and ensure CRO study team resolve identified concerns • Collaborate with sponsor CPM and sponsor Medical Monitor for country and site identification, feasibility and selection to optimize processes to ensure efficient start-up timelines are met.
Manage study start up in collaboration with internal and external project teams (e.g. sponsor Project Manager, Regulatory, Clinical Supplies, Third Party Vendors, CRO) to ensure start up timelines are clearly defined and implemented, working to identify any risks and resolving any issues.
Provide routine updates to the internal project team on study status/issues
Manages the CRO/clinical trial site during start-up activities including, but not limited to, budget and contract negotiations, IRB/EC submissions and response and facilitation of essential document collection
Provide direction and support to the CPM in ensuring consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate.
Manages consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate
Works cross-functionally with other sponsor departments (Clinical Supplies, Quality Assurance, Regulatory Affairs) to ensure all clinical trial activities performed by sponsor as a Sponsor are performed according to study requirements and timelines.
Contribute to the development and/or participate in the review of study related documents including (but not limited to) site feasibility, protocol, informed consent documents (master and/or site specific), budgets, monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals, case report form development and training materials
Execute and/or deliver trial specific training as required
Review of open action items and data trends; working with CROs to escalate and resolve identified issues to ensure standards for monitoring and reporting are met as well as to ensure better efficiencies and execution of our studies
Contribute to the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan
May oversee the accurate, timely, and complete tracking of laboratory samples
Contribute to the development and/or participate in the review of sponsor SOPs, Work Instructions and team policies
Supports the internal and external project teams with audits/inspection readiness and activities, resolution of audit/inspection findings and contribution to CAPAs as required
Oversight of direct report(s) study execution and procedures as required to ensure regulatory compliance of protocol activities, if appropriate
Accountable for ensuring all study deliverables and milestones are met with quality and within timelines
Provide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets
At least 8 years of relevant clinical operational experience in a biotechnology/pharmaceutical company, and/or CRO
familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus
Experience with start-up and initiation of clinical trial sites
Experience creating and maintaining healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required
Proactively identify project challenges/risks and appropriate corrective actions to the internal study teams and work with internal team, clinical sites and vendors on resolutions with minimal supervision
Experience presenting high level presentations, both orally and in writing
Knowledge of and experience with immunotherapies and/or Oncology
At least 2 years of on-site monitoring experience
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