Project Manager, Start-up

2 weeks ago

Vancouver, Canada Labcorp Full time

**Project Manager, Start-Up**:
**This position can be home based, within the US and Canada.**:
**The Start-up Project Manager oversees and manages the start-up through maintenance phase of domestic and/or international clinical trials. Responsibilities include project managing defined study start-up and maintenance activities within timelines, scope, quality and budget, ensuring that client’s expectations are met.**:
**Essential Job Duties**:

- ** Depending on the scope of the project and experience level, job duties below, may be performed independently as a Lead SUPM or in collaboration with a Lead SUPM as a Regional SUPM.**:

- ** Lead SUPM is accountable for all job duties below.**:

- ** Regional SUPM supports Lead SUPM by leading below job duties on a regional level.**:

- ** Lead start-up team during study start-up phase liaising directly with Lead SUPM or Project Lead, core team members and the client.**:

- ** 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.**:

- ** Proactively engage 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.**:

- ** 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 submissions 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. Proactively identify and escalate any risks to meting deliverables. Propose effective mitigation plan, as applicable.**:

- ** Monitor Green Light (GL) approval and Site Ready to Enro**l**l (RTE) regionally to ensure deliverables are met. Proactively identify and escalate any risks to meeting deliverables.**:

- ** Prepare and present as operational lead in internal Project Review meetings, if in a lead role. Depending on the 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**:

- ** Mentor Associate SUPMs**:

- ** Perform other duties as assigned by management**:
***:
**Finance Management**:
***:

- ** Ensure that work is performed within the budget. Interpret billing guidelines for the functional area/region and schedule training for startup 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 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.**:

- ** Resolve conflicts as needed.**:

- ** Escalate non-compliance related to maintaining professional standards, following processes and SOPs to respective line managers and/or QA.**:

- ** Schedule and

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