Job Description

Centralized Start-Up Lead

Home-Based

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Did you know?

Labcorp\'s Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea\xe2\x80\x99s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.

Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit .

Essential Job Duties:

• 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\xe2\x80\x99s expectations are met.

• 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.

• 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\xe2\x80\x99s 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.
• 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.

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.

Minimum Experience 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 > 6 months
• Direct Sponsor contact

Preferred

• Undertaken similar activities in > 1 country for more than 6 months
• Experience in oversight of start-up activities
• Experience outside of region

Education 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.

Pay Range: $70,000 - $90,000/year

Benefits: All job offers will be based on a candidate\xe2\x80\x99s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please .

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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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