Job Summary:
The Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the regional/local level. CTMs contribute to delivery of the pipeline through accurate planning and efficient execution of trials that bring speed & value to participating patients and sites.
Key Accountabilities:
Trial Preparation
Accountable for the trial activities for responsible R/OPU, including but not limited to:
• Ensure the trial is conducted in compliance with GCP-ICH, local/global regulations, applicable SOPs and according to the trial protocol by overseeing CRO and internal team activities.
• Creation, management and review of the R/OPU trial budget to ensure appropriate level of financial oversight and planning accuracy. Timely budget updates based on trial changes.
• Appropriate trial-specific training of R/OPU internal and external partners is performed in line with Trial Training Plan.
• Accurate planning and co-ordination of operational feasibility of trial timelines for their R/OPU; and oversight of trial preparation to ensure trial team members are aligned and on track.
• Verifies and provides input into the country and site level feasibility and OPU commitment (site and patient commitment). Finalize and validate site selection using available data sources and local insights/expertise, in collaboration with other functions (i.e. Medical Affairs, vendors if applicable).
• Development and implementation of country level engagement plans, recruitment planning and risk mitigation. Co-ordinates development of country level patient facing documents in close collaboration with relevant internal and external stakeholders. Reports patient and site level feedback as strategic insight to contribute to improving trial design with a focus on patient value
• Frontloading of activities where possible at the R/OPU level to facilitate efficiencies as well as to ensure and leverage speed.
• Oversees outsourcing of vendor services in the R/OPU in accordance to operating models and governance.
• Ensure timely responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders.
Trial Conduct
• Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation. In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, and safety reporting.
• Monitor progress of patient recruitment endpoints and proactively update and action contingencies throughout trial conduct.
• Support CTL during investigator meetings
• Establish and maintain relationships with external experts, investigational sites, Patient Organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst CD&O and appropriate functions (i.e Medical Affairs, Market Access, PAR) on regional/ local level.
• Active participation in the CD&O community with a special focus on participating in the CTM network, to actively contribute to functional excellence.
Trial Closeout and Reporting
• Ensures timely cleaning and delivery of clinical trial data.
• Responsible for timely, complete and compliant archiving of all relevant R/OPU documents in the TMF, including all required documents from vendors.
• Ensures timely submission of the CTR to Regulatory Authority/Ethics Committee and other external stakeholders as required by local regulations
• Shares information on trial results with Investigational sites and, if applicable, Patients (e.g. lay summaries).
General accountabilities
• Build and maintain engagement with Investigators, other site staff and Patient Organizations (POs), in collaboration with other functions, to ensure trial speed and effective start up, conduct and close out.
• Establish and maintain relationships with external experts, investigational sites, Patient Organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst CD&O and appropriate functions (i.e Medical Affairs, Market Access, PAR) on regional/ local level.
• Supports CTL to ensure issues are raised to Evidence team for timely action or mitigation.
Interfaces:
Functional lead and/or project manager of local/regional trial team members and colleagues including but not limited to:
• CD&O
• Other medical functions
• Local/ regional HP functions (including patient advocacy)
• CRO and other suppliers
• Investigator and site staff
• Research networks
• Patient organizations (PO)
Requirements:
• 4+ years of local (Canada) clinical trial management experience in a pharma or FSP setting is required
• In-depth understanding of project management with emphasis on team work to promote high-performance teams
• Understanding of local/regional major regulations
• Familiarity with guidelines and standard of care is desirable
• Experienced in working with CROs and POs is desirable
• Ability to build and maintain strong relationships of mutual value
• Excellent influencing and communication skills
Minimum Education Requirements:
• Requires a university degree (e.g. Bachelor's, Masters degree or comparable degree) with several years relevant experience in required area. Major focus: Biomedical Life Sciences
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