Centralized Start-up Lead

Essential Job Duties: 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. GENERAL 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. JOB SPECIFICS 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. COVANCE LEADERSHIP OVERSIGHT/QUALITY ASSURANCE Responsible for appropriate issue escalation to QA Triage and/or appropriate stakeholder(s). Support audits (internal and external) and inspections, as needed. Support resolution of any findings. **Experience**: Minimum Required: Four (4) or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO), including demonstrated skills and competency in study start-up and/or amendment management. Preferably local project coordination and/or project management experience Required Undertaken similar activities for > 6 months Direct Sponsor contact Preferred Undertaken similar activities in > 1 country for more than 6 months Experience in oversight of start-up activities Experience outside of region Education/Qualifications/Certifications and Licenses Recommended: **Labcorp is proud to be an Equal Opportunity Employer**: As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status. For more information about how we collect and store your personal data, please see our Privacy Statement.