Clinical Team Lead

Clinical Team Lead (Clinical Trial Manager)

Remote - USA

Labcorp Drug Development gives you the best two-for-one opportunity for career growth. Who doesn’t want twice the perks? Working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus. You can have it all!

Dedicated to an FSP project, you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance, we have an FSP opportunity to match your area of expertise.

You will enjoy the best of both worlds—all the benefits that come along with our Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor and this also comes with the benefit of bringing your strong therapeutic experience to allow your expertise to shine through.

Our FSP model is flexible and scalable. Our teams are collaborative and proactive – a great place for you to continue honing your therapeutic skills and growing and excelling in new and exciting research.

Our reach is global – extending to 60 countries making us one of the largest FSP CROs. No matter where you are located on the globe, we have an FSP opportunity for you.

The Clinical Team Lead (CTL) is responsible and accountable for the execution of the clinical operations component of the project, at the global or regional level, as assigned. The CTL is responsible for working cross functionally, within a matrix environment, to ensure successful execution of the trial including oversight of the clinical operations from a quality, timeline, budget and scope perspective.

Essential Job Duties:

• Responsible for clinical project delivery with regards to agreed time, scope, cost and quality.
• Key clinical deliverables include but are not limited to: o Patient recruitment and retention
  • Ensuring the clinical project team is resourced effectively
  • Agile management of the Monitoring Visit Strategy
  • Management of SDV burden
  • Clinical vendor delivery
  • Management of clinical deliverables related to protocol endpoints
• Responsible for leading clinical deliverables across the following functions (this list is not exhaustive and may change dependent on the study): o Clinical Team Leads
  • Clinical Research Associates (CRA)
  • Inhouse CRAs
  • GSDM Clinical Functions
  • TMF Delivery Center
  • Clinical and Ancillary Supplies Services
  • Regulatory Affairs (post initial approval)
  • Local Site Start-Up Operations (post initial approval)
  • Site ID
• Support/Lead Clinical project team ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders.
• Serve as escalation point for clinical project issues, within area of project responsibility, to internal and external stakeholders, as appropriate.
• Serve as key client contact for assigned project responsibilities, establishing working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business. Depending on size and scope of project(s), this job duty may be performed in collaboration with a Senior CTL and/or CPDM.
• Proactively identify and resolve conflicts as needed.
• Understand the clinical project delivery strategy, costing assumptions and resulting budget for assigned project(s).
• Monitor clinical project scope, schedule and costs to ensure all remain on track with the contract and with financial performance targets.
• Proactively lead both quality control and risk assurance activities to ensure clinical project deliverables are met according to regulatory, Covance and client requirements.
• Ensure successful creation and implementation of required clinical project plans. Monitor progress and manage variance to required clinical project plans and revise as necessary per SOPs. Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs, providing performance feedback to team member’s respective supervisors.
• Track and maintain key clinical project performance indicators for specified client and internal metrics. Drive successful clinical team delivery on these KPIs/metrics.
• Define and manage clinical project resource needs and establish succession plans for key resources.
• Perform other duties as required by the Department or Project Team
• In collaboration with relevant departments, prepare and deliver presentations for new business as required.
• Trains & mentors CRAs and IHCRAs in multiple areas of expertise.

Education / Qualifications:

• Must have a Bachelor’s Degree (or equivalent)
• COVID-19 vaccination required

Experience Required:

• 2-4 years’ experience as a CTL, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
• Minimum 4 years CRA experience, on-site or in-house.

Or

• In lieu of the above minimum requirement, candidates with 6 or more years of relevant clinical research experience in the pharmaceutical or CRO environment will be considered.

Labcorp is proud to be an Equal Opportunity Employer:

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