As Associate Start-up Project Manager you will oversee and manage the start-up phase of domestic and/or international clinical trials, primarily on a regional level but may also hold a lead role depending upon your level of experience. Responsibilities include project managing defined study start-up activities within timelines, scope, quality and budget, ensuring that client’s expectations are met and overseeing the maintenance phase, as applicable.
- Serve as client’s contact for start-up and maintenance processes and oversight.,. Responsible for establishing a strong working relationship with client’s project teams.
- Monitor and control start up project schedule, budget, and scope . byroactively engaging in both quality assurance and risk management activities to ensure project deliverables are met..
- Initiate improvements to enhance the efficiency and the quality of the start-up work performed on assigned projects.
- For all Start-up staff, identify and escalate non-compliance related to maintaining professional standards, following processes and SOPs to respective line managers and/or QA,
Schedule and conduct start-up related trainings, as applicable to project teams (both internal and external).
- Ensure local staff have access and are trained on applicable systems.
- Provide performance feedback of team members to respective line managers and project management team.
- In a lead role, develop a site activation and maintenance strategy in conjunction with the Project Lead, other functional groups and the client to ensure start-up and maintenance deliverables are completed within agreed project timelines and in accordance with client’s expectations.
- Create or review required project start-up plans. Distribute, implement and monitor compliance to project plans and revise as necessary. Review Client vs CRO responsibilities related to start-up.
- 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.
- Review and provide input to core study documents as applicable.
- Proactively manage site activation and maintenance progress, expectations and deliverables to a Lead SUPM or the Project Lead/client, as applicable
- Present at external and internal meetings including, but not limited to: project core team and client meetings, Chapter Meetings, Kick Off Meetings.
- Distribute start-up and maintenance related documents to local start-up staff and oversee the customization to local requirements.
- Oversee ethics and regulatory bodies, submission and approval status. Coordinate addressing queries ensuring required timelines are met.
- Ensure preparation and distribution of core and country specific contract and budget templates to applicable project team members
- Oversee Investigator Package compilation and green light approval regionally and/or globally and proactively identify and escalate any risks to meeting deliverablesPropose effective mitigation plan, as applicable.
- Monitoring Green Light (GL) approval regionally to ensure deliverables are met, and proactively identify and escalate any risks to meeting deliverables.
COVANCE LEADERSHIP OVERSIGHT/QUALITY ASSURANCE
- Prepare and present as operational lead in internal Project Review meetings, if in a lead role. Depending on the size and scope of project, this job duty may be performed in collaboration with a Lead SUPM, Start-up Senior Project Manager, and/or Start-up Project Director.
- 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.
- Support RFP development and attend at Bid Defense Meetings, if required
- Perform other duties as assigned by management.