Global Senior Trial Delivery Manager - Sponsor Dedicated

Global Trial Delivery Manager services provide for the global coordination of clinical trial management activities for internally managed and / or outsourced trials. These services lead the Study Management Team (SMT) and ensure global clinical operations deliverables progress according to agreed upon timelines and milestones, including country & site feasibility and site selection, trial set-up, trial execution and trial closure and vendor set up activities as assigned by the Global Clinical Development Operations Trial Leader (GTL). This service supports the GTL in leading related CRO, country, and site activities, including global vendors involved in site facing activities such as IVRS, Central Lab, ePRO, Imaging, Translation, Printing, Ancillary supplies and Meeting Planners. Interface with stakeholders; internal and external to Global Clinical Development Operations (GCDO) functions, such as Study Responsible Physician, Global Data Manager, Trial Supply Manager, CRO staff, vendor staff and trial sites (if applicable). Work closely with the GCDO Trial Leader (GTL) and is member of the Trial Team, led by the GTL. Ensure inspection readiness through compliance with the clinical research protocol, company Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through close-out. Takes ownership for assigned responsibilities. Demonstrated competency to act as a backup or first point of contact in absence of the GCDO Trial Leader. Advanced is given assignments that are more complex and / or have a greater potential impact on business results. May act as the lead over a team of CTMs across a project / program, on insourced and outsourced studies. Able to lead taskforces and provide innovative input. May contribute to process improvement and / or non-project work.

Task :

• Services rendered will adhere to applicable to sponsor´s SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
• Complies with relevant training requirements.
• Lead the Study Management Team including providing updates to all trial team members on deliverable status.
• Ensure availability of required reports to support real time tracking of trial status according to trial plan.
• Manage timely and accurate documentation and communication of trial progress.
• Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness.
• Act as primary contact for Country and Regional staff.
• Act as the primary contact person for the local teams within GCDO.
• Partner with the Global Trial Lead to execute and oversee central activities from planning, trial start up, through the life of trial to close-out.
• Ensure issue escalation and drive issue resolution.
• Work closely with Trial Team to ensure CAPAs are resolved timely. Act as CAPA owner or contributor, as appropriate.
• Contribute to data collection to support the site selection process.
• Participate in feasibility, providing recommendations as needed.
• Establish enrollment commitments and ensure actual enrollment meets projected commitments across the regions at the clinical trial level.
• Ensure the availability of robust recruitment / contingency plans are in place for each region.
• Ensure timely tracking and filing in appropriate systems, as required at central trial oversight level.
• Perform Annual Quality Review of files, as appropriate.
• Ensure archiving and retention of documents per set requirements.
• Establish country budgets and monitor actuals vs. forecast for Out-of-Pocket Expenses.
• Oversight of selected vendors and status of related deliverables.
• Review and approve assigned vendor invoices / spend.
• Monitor budgets and expenditures as expected per planned trial budget.
• Create and update trial-specific documents as required, including Monitoring Guidelines, Informed Consent Form, Investigational Medicinal product (IMP) related documentation, Blinding Plan, country and site feasibility related documents.
• Provide input into cross functional documents such as safety related documents, protocol deviations and issue escalation processes, External Service Provider Oversight Plan and the Filing and Archiving Plan.
• Provide central documents required for HA / EC / IRB submission.
• Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional / site / CRO staff and delivering training as needed.
• Responsible for the set-up, coordination, attendance participation of Investigator Meetings.
• Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit.
• Demonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge.
• Ensure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes.
• Participate in preparation for, and conduct of, Health Authority inspections and internal audits.
• Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
• Coordinate data cleaning with some supervision towards a timely and successful database lock.
• Act as central expert for assigned protocol(s).
• Sufficient therapeutic knowledge to support defined CTM roles and responsibilities.
• Contribute to process improvement and training, as applicable.

Requirements :

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