Associate Project Manager, Start-up

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. 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. 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 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.
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. 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.
COVANCE LEADERSHIP OVERSIGHT/QUALITY ASSURANCE *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.
OTHER
- Support RFP development and attend at Bid Defense Meetings, if required
- Perform other duties as assigned by management.
Education/Qualifications/Certifications and Licenses
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.
**Experience**:
Minimum Required:
- Four (4) or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO), including demonstrated skills and competency in clinical project management tasks, especially regarding study start-up.
- Preferably Local project coordination and/or project management experience, especiall

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