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Tmf Lead Ii

7-10 years
Not Disclosed
10 Aug. 23, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

Fortrea is a leading global Contract Research Organization (CRO) renowned for its scientific rigor and extensive clinical development expertise. We offer a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff members operating in more than 90 countries, Fortrea is dedicated to transforming drug and device development for partners and patients worldwide.

Position Overview:

As the primary point of contact for the TMF Delivery Center for assigned studies, you will:

  • Lead TMF Kick-off Meetings: Conduct meetings with sponsors and the LabCorp project team to align expectations, requirements, and deliverables in line with ICH guidelines.
  • Oversee TMF Management: Manage the planning, setup, maintenance, quality control, and closure of the study TMF according to agreed processes (Labcorp or sponsor SOPs), working closely with key study personnel.
  • Ensure System Access: Confirm and manage internal and external system access requirements.
  • Maintain TMF Documentation: Develop and maintain the TMF Plan and TMF Index in collaboration with the Project Manager/Project Lead and Sponsor.
  • Compliance and Training: Ensure compliance with current LabCorp eTMF system training requirements and provide necessary training to the project team on the TMF plan and Index.
  • Document Deviations: Record and escalate deviations from standard processes, documenting them in the TMF Plan or other relevant documents.
  • Handle Compliance Issues: Document and escalate compliance issues, following up until resolution or CAPA implementation.
  • Manage Scope and Requests: Monitor project scope, communicate out-of-scope activities, and handle sponsor-specific report requests.
  • Prepare for Audits: Oversee the preparation of the TMF for QA or sponsor audits and inspections, participating as required and addressing any CAPAs issued.
  • Maintain Audit Readiness: Ensure the TMF is always audit-ready by managing document lists and maintaining "real-time" updates.
  • Review and Monitoring: Oversee the timely kickoff of TMF review workflows, monitor completeness at each milestone, and escalate issues as necessary.
  • Process Artifacts: Manage the processing of essential artifacts throughout all study phases per SOPs and guidelines.
  • Lead Governance Meetings: Conduct project review and governance meetings and report on key performance indicators (KPIs).
  • Identify Trends: Detect and report trends per study and across programs, providing insights to management.
  • Assist in Remediation: Support the TMF Remediation team as needed and contribute to business development opportunities.
  • Handle Technical Issues: Act as the point of contact for technical issues encountered by other TMF DC roles during TMF maintenance.

Qualifications:

  • 7 to 10 years of relevant experience in eTMF management.

Why Join Us:

Fortrea is seeking motivated problem-solvers and creative thinkers who are passionate about overcoming challenges in clinical trials. We are committed to revolutionizing the development process and ensuring the swift delivery of life-changing therapies to patients. Join our dynamic team and thrive in a collaborative environment where personal growth is fostered, and you can make a meaningful global impact.

Fortrea is an Equal Opportunity Employer:

We are committed to diversity and inclusion and do not tolerate harassment or discrimination of any kind. Employment decisions are made based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender (including pregnancy or medical conditions), family status, marital status, sexual orientation, gender identity, gender expression, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all qualified individuals to apply.

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For more information about Fortrea, visit www.fortrea.com.