Job Description

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\xe2\x80\x99s expectations are met. Job duties include overseeing the maintenance phase, as applicable.

Essential Job Duties:

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.

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\xe2\x80\x99s contact for start-up and maintenance processes and oversight. Responsible for establishing a strong working relationship with client\xe2\x80\x99s 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\xe2\x80\x99s 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.

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, especially regarding study start-up.

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 four (4) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.

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.

Did you know?

In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.

We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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