Start-Up Project Manager
Buenos Aires, Argentina
hace 8 horas

Job Overview :

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, 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. 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.

  • 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.

  • 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 to project teams (both internal and external), as applicable.
  • Ensure local staff has 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. 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.

  • 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
  • Perform other duties as assigned by management.
  • Education / Qualifications :

    Recommended :

  • 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.

    Preferred :

  • Masters or other advanced degree.
  • PMP certification.
  • Working knowledge of Covance and the overall structure of the organization.
  • Basic knowledge of Covance sales and business development strategies and procedures.
  • Working knowledge of Covance SOPs.
  • Experience : Minimum Required :

    Minimum Required :

  • Five (5) or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO), preferably including two (2) or more years project management responsibility / leading clinical trials in Study Start-up.
  • Experience in managing projects in a virtual environment.
  • Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
  • Financial awareness and ability to actively utilize financial tracking systems.
  • Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
  • Demonstrated ability to lead by example and to encourage team members to seek solutions independently.
  • Excellent communication, planning and organizational skills.
  • Ability to review / analyze and report relevant data and interpret protocols and regulatory documents.
  • Ability to work independently.
  • Ability to negotiate and liaise with clients in a professional manner.
  • Ability to present to staff at all levels.
  • Strong computer skills with an ability to understand, access and leverage technology alternatives..
  • A working knowledge of ICH GCP, US FDA regulations, regulations applicable to local office, guidelines, and practices regarding Good Clinical Practices.
  • Detailed knowledge of financial control procedures (i.e. costing systems, time reporting).
  • Working knowledge of project management processes, especially concerning study start-up.
  • Working knowledge of time and cost estimate development.
  • Broad knowledge of drug development process and client needs.
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