Covance

  • SSU Assoc Project Manager (Mexico)

    Job Location(s) MX
    Job Number
    2018-20679
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    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.

     

      

    GENERAL                                             

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

    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 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.
    • 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.

     

    JOB SPECIFICS

    • 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.

    OTHER

    • Support RFP development and attend at Bid Defense Meetings, if required

     

    • Perform other duties as assigned by management.

    Education/Qualifications

    University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution. In lieu of the above requirement, candidates with five (5) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered. 

    Experience

    • Previous relevant clinical research experience including demonstrated skills and competency in clinical project management tasks, especially regarding study start-up.
    • Local project coordination and/or project management experience, especially regarding study start-up.

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