Ass. Project Manager Start-up

Summary of Responsibilities:

• Primarily oversees and manages amendment phase of domestic and/or international clinical trials. Where required, may also take on start-up tasks under the direction of a Project Manager, Start-up. Responsibilities include project managing defined study activities within timelines, scope, quality and budget, ensuring that client's expectations are met.

GENERAL

• Lead the team through the amendment phase of a study.
• Responsibilities may also include activating sites in active start-up.
• Serve as primary client contact with autonomy to interact directly with the client on a broad range of contract amendment issues and decisions.
• Monitor and control project schedule. Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met.

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 independently 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.
• Identify and escalate non-compliance related to maintaining professional standards, following processes and SOPs to respective line managers and/or QA.
• Provide performance feedback of team members to respective line managers and project management team.

JOB SPECIFICS

• Develop an amendment submission and approval strategy in conjunction with the Project Lead, other functional groups and the client to ensure amendment deliverables are completed within agreed project timelines and in accordance with client's expectations.
• Proactively manage amendment progress, expectations and deliverables.
• 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.
• Oversee preparation of amendment submission including but not limited to ICF updates/review/approval and other necessary documents.
• Oversee ethics and regulatory bodies submission and approval status. Coordinate addressing queries ensuring required timelines are met.
• Contribute to a Start-Up Plan if required, overseeing Investigator Package compilation, green light approval and contributing to a cross functional team ensuring that sites achieve Ready to Enroll status on time.
• Review and provide input to core study documents, as applicable.
• Present at external and internal meetings including, but not limited to: project core team and client meetings.

FORTREA LEADERSHIP OVERSIGHT/QUALITY ASSURANCE

• 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.
• And all other duties as needed or assigned.

Qualifications (Minimum Required):

• 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 four (4) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Fluent in English, both written and verbal.

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 study start-up and/or amendment management. Preferably local project coordination and/or project management experience
• Required:
• Undertaken similar activities for greater than 6 months
• Direct Sponsor contact

Preferred Qualifications Include:

• Four (4) or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO), including demonstrated skills and competency in study start-up and/or amendment management. Preferably local project coordination and/or project management experience.
• Required:
• Undertaken similar activities for greater than 6 months.
• Direct Sponsor contact.
• Preferred:
• Undertaken similar activities in greater than 1 country for more than 6 months.
• Experience in oversight of start-up activities.
• Experience outside of region.

Physical Demands/Work Environment:

• Standard office environment/home-based environment.
• Travel Requirements: Domestic, Regional and Global.
• Available for domestic and international travel, including overnight stays.

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