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    Tmf Lead Ii

    Fortrea
    4+ years
    Not Disclosed
    Bangalore
    10 Aug. 8, 2024
    Job Description
    Job Type: Full Time 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

    TMF Delivery Center Point Person at Fortrea

    Company Overview:

    Fortrea, a leading global contract research organization (CRO), is dedicated to scientific excellence with decades of experience in clinical development. We offer a broad range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 employees in more than 90 countries, Fortrea is at the forefront of transforming drug and device development for partners and patients worldwide.

    Position: TMF Delivery Center Point Person

    Key Responsibilities:

    • Project Oversight: Act as the primary TMF Delivery Center point person for assigned studies, ensuring alignment with ICH guidelines and project scope.
    • Kick-off Meetings: Conduct TMF-specific kick-off meetings with sponsors and the Labcorp project team to establish expectations, requirements, and deliverables.
    • TMF Management: Oversee the planning, setup, maintenance, quality control, and closure of the study TMF in accordance with Labcorp or sponsor SOPs, working with key study personnel.
    • Access Management: Confirm and manage internal and external system access needs in collaboration with the TMF access management team.
    • TMF Plan & Index: Create and maintain the TMF Plan and TMF Index in collaboration with the Project Manager/Project Lead and Sponsor.
    • Compliance & Training: Ensure compliance with current eTMF system training requirements and provide project team training on TMF plans and indices as needed.
    • Deviation Documentation: Document and escalate compliance issues, following up on findings until resolution or CAPA implementation.
    • Scope Management: Monitor project scope, communicate any out-of-scope activities or requests to the Project Lead.
    • Report Requests: Evaluate feasibility and ensure delivery of sponsor-specific report requests in collaboration with TMF operational services and system experts.
    • Audit Preparation: Prepare the TMF for QA or sponsor audits and inspections, participate in audits, and respond to CAPAs as required.
    • Audit Readiness: Maintain TMF in a state of audit/inspection readiness by completing initial matching of the Index with the Expected Document List (EDL) and ensuring ongoing EDL updates.
    • Milestone Reviews: Oversee the timely kickoff of TMF Review Workflows and monitor completeness at each Milestone Review.
    • Artifact Processing: Ensure the processing of essential artifacts throughout all study phases in accordance with SOPs, GCP, and ICH guidelines.
    • Governance Meetings: Lead project review/governance debrief meetings and report on key performance indicators (KPIs) and study metrics.
    • Trend Analysis: Identify trends and alert management of any issues as applicable.
    • Quality Assurance: Review and respond to TMF content quality issues and assist with TMF remediation as needed.
    • Training & Mentoring: Provide training and mentoring as required, contribute to drafting job aids and work instructions, and assist with migration if necessary.
    • Technical Support: Act as the point of contact for technical issues faced by TMF Delivery Center roles during TMF maintenance.

    Why Join Fortrea?

    At Fortrea, we are committed to revolutionizing the clinical trial process and delivering life-changing therapies to patients. Join our dynamic and collaborative team to make a meaningful global impact. For more information, visit www.fortrea.com.

    Equal Opportunity Employer:

    Fortrea is an Equal Opportunity Employer (EOE/AA) committed to diversity and inclusion. We do not tolerate harassment or discrimination of any kind. Our employment decisions are based on business needs and individual qualifications without discrimination based on race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all qualified individuals to apply.

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

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