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Clinical Team Lead - Fsp (Remote)

2+ years
Not Disclosed
10 Oct. 24, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About Fortrea
As a leading global contract research organization (CRO), Fortrea is passionate about scientific rigor and has decades of clinical development experience. We offer a comprehensive range of clinical development, patient access, and technology solutions to our pharmaceutical, biotechnology, and medical device clients across more than 20 therapeutic areas. With operations in over 90 countries, Fortrea is transforming drug and device development for partners and patients around the globe.

Position Overview
Title: Clinical Trial Lead (CTL)
Location: Remote - USA

In this role, you will be responsible for driving the delivery of clinical project deliverables, acting within the Clinical Project Management (CPM) role within the Core Team or supporting the CPM as assigned. You will work cross-functionally in a matrix environment to ensure the successful execution of trials, overseeing clinical operations from quality, timeline, budget, and scope perspectives.

Key Responsibilities

  • Clinical Project Delivery:
    Ensure successful delivery of clinical projects regarding agreed time, scope, cost, and quality, including:

    • Patient recruitment and retention.
    • Effective resource allocation for the clinical project team.
    • Agile management of the Monitoring Visit Strategy.
    • Clinical vendor delivery.
    • Management of clinical deliverables related to protocol endpoints.
  • Team Leadership:
    Lead clinical deliverables across various functions, including:

    • Clinical Team Leads.
    • Clinical Research Associates (CRA).
    • In-house CRAs.
    • Regulatory Affairs (post-initial approval).
    • Local Site Start-Up Operations (post-initial approval).
  • Cross-Functional Collaboration:
    Support and lead the clinical project team, ensuring effective teamwork among internal and external stakeholders. Serve as the escalation point for project issues.

  • Client Relationship Management:
    Act as the key client contact for assigned project responsibilities, establishing strong working relationships that result in client satisfaction and operational excellence.

  • Monitoring and Reporting:
    Understand the clinical project delivery strategy and budget, monitoring scope, schedule, and costs to ensure alignment with contract and performance targets.

  • Quality and Risk Assurance:
    Proactively lead quality control and risk assurance activities to meet regulatory, Covance, and client requirements.

Education and Experience

  • Education:
    University or college degree, or certification in a related allied health profession (e.g., nursing licensure). Equivalent experience may be considered.

  • Experience:

    • 0-4 years of experience as a CTL or an equivalent combination of education and experience.
    • Minimum 4 years of CRA experience (on-site or remote; not in-house).
    • Alternatively, candidates with 6+ years of relevant clinical research experience in pharmaceutical, CRO, or healthcare settings will be considered.

Why Join Fortrea?
At Fortrea, we are seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment is to revolutionize the development process, ensuring the swift delivery of life-changing therapies to patients in need. Join our exceptional team and enjoy a collaborative workspace that fosters personal growth and enables you to make a meaningful global impact.

Equal Opportunity Employer
Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to protected characteristics. We encourage all qualified individuals to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

Visit Fortrea's website for more details.