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Centralized Start-up Lead
Primarily oversees and manages amendment phase of domestic and/or international clinical trials. Where required, may also take on start-up tasks under the direction of a Project Manager, Start-up. Responsibilities include project managing defined study activities within timelines, scope, quality and budget, ensuring that client’s expectations are met.
- Lead the team through the amendment phase of a study.
- Responsibilities may also include activating sites in active start-up
- Serve as primary client contact with autonomy to interact directly with the client on a broad range of contract amendment issues and decisions
- Monitor and control project schedule. Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met. FINANCE MANAGEMENT
- Ensure that work is performed within budget. Interpret billing guidelines for the functional area/region and schedule training for start-up team accordingly
- Proactively identify risk of over-spend and track project progress against financial milestones using applicable financial systems.
- Implement and follow pre-approved procedures for write off or budget overages. RESOURCE MANAGEMENT
- Determine needs, request, and independently manage project start-up resources. Adapt/request resources as applicable to ensure project deliverables are met.
- Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services.
- Identify and escalate non-compliance related to maintaining professional standards, following processes and SOPs to respective line managers and/or QA.
- Provide performance feedback of team members to respective line managers and project management team.
- Develop an amendment submission and approval strategy in conjunction with the Project Lead, other functional groups and the client to ensure amendment deliverables are completed within agreed project timelines and in accordance with client’s expectations
- Proactively manage amendment progress, expectations and deliverables
- Understand client expectations for deliverables/milestones, and liaise with applicable functional teams in creation and modification of site activation timelines throughout the lifecycle of the project
- Oversee preparation of amendment submission including but not limited to ICF updates/review/approval and other necessary documents
- Oversee ethics and regulatory bodies submission and approval status. Coordinate addressing queries ensuring required timelines are met
- Contribute to a Start-Up Plan if required, overseeing Investigator Package compilation, green light approval and contributing to a cross functional team ensuring that sites achieve Ready to Enroll status on time
- Review and provide input to core study documents, as applicable.
- Present at external and internal meetings including, but not limited to: project core team and client meetings.
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