Associate Project Manager, Ssu

1 week ago

Vancouver, British Columbia, Canada Labcorp Full time

Labcorp Drug Development


As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries.

Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

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Associate Project Manager, Start-Up

Home-Based


The Associate Start-up Project Manager oversees and manages the start-up phase of domestic and/or international clinical trials, primarily on a regional level but can hold a lead role depending upon SUPM experience level.

Responsibilities include project managing defined study start-up activities within timelines, scope, quality and budget, ensuring that client's expectations are met.

Job duties include overseeing the maintenance phase, as applicable.

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.

Essential Job Duties:

  • Lead startup team during study startup phase liaising directly with Lead SUPM or Project Lead, core team members and the client, as applicable.
  • Serve as client's contact for startup 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 startup 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 startup and maintenance deliverables are completed within agreed project timelines and in accordance with client's expectations.
  • Create or review required project startup plans. Distribute, implement and monitor compliance to project plans and revise as necessary. Review Client vs CRO responsibilities related to startup.
  • 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 startup and maintenance related documents to local startup 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. Proactively identify and escalate any risks to meeting deliverables. Propose effective mitigation plan, as applicable.
  • Monitor Green Light (GL) approval regionally to ensure deliverables are met. Proactively identify and escalate any risks to meeting deliverables.
  • Oversee maintenance activities through the lifecycle of the project.

FINANCE MANAGEMENT

  • Ensure that work is performed within budget. Interpret billing guidelines for the functional area/region and schedule training for startup team accordingly
  • Proactively identify risk of overspend and track project progress against financial milestones using applicable financial systems.
  • Implement and follow preapproved procedures for write off or budget overages.

RESOURCE MANAGEMENT

  • Determine needs, request, and manage project startup resources. Adapt/request resources as applicable to ensure project deliverables are met.
  • Ensure effective crossfunctional teamwork among project team members including both internal and external ancillary services.
  • Resolve conflicts as needed.
  • For all Startup staff, identify and escalate noncompliance related to maintaining professional standards, following processes and SOPs to respective line managers and/or QA,
  • Schedule and co

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