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Validation/Quality Manager I - Clinical

4-6 years
Not Disclosed
10 Nov. 22, 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

Company Description

Katalyst Healthcares & Life Sciences is hiring entry-level candidates for multiple positions in clinical research involving drugs, biologics, and medical devices. We offer immediate opportunities in Drug Safety, Pharmacovigilance, and Clinical Research, collaborating with university hospitals, pharmaceutical companies, and recruiting partners.


Job Description

Position: TMF Quality Control Specialist

As a TMF Quality Control Specialist, you will serve as the Single Point of Contact (SPOC) for Therapeutic Areas (TA) and Clinical Trial Teams (CTT), ensuring high-quality management of Trial Master Files (TMFs) and compliance with regulatory guidelines.


Key Responsibilities

  • Act as the Subject Matter Expert (SME) on TMF Quality Control (QC) for therapeutic areas and clinical trial teams.
  • Oversee external partners' document management work specific to TMF processes and ensure documentation compliance.
  • Develop, optimize, and deliver TMF QC training materials and mechanisms.
  • Translate trial information, processes, and regulations into TMF documentation.
  • Perform specified quality checks on essential clinical documents per established processes.
  • Track progress on Key Quality Indicators (KQIs) and overall compliance with TMF regulations and processes.
  • Supervise TMF QC Specialists, monitor their work, and provide training/mentoring on reconciliation, QC, and TMF processes.
  • Generate TMF QC reports and assist CTT members with TMF-related queries and compliance.
  • Lead TMF filing plan development and monitor compliance during trial setup, execution, and closeout phases.
  • Serve as a point of contact for system access and technical support for tools like eTRAC and Clinical Document Management Systems.
  • Participate in global initiatives to improve clinical development processes and TMF compliance.
  • Train and mentor new staff while maintaining high operational standards and adherence to timelines.

Skills and Experience Required

  • Education:
    • Bachelor’s degree in life sciences/healthcare with 4+ years of experience in clinical operations or clinical systems management.
    • Associate degree with 6+ years of relevant experience.
  • Strong knowledge of the clinical development process, regulatory requirements, and Good Clinical Practice (GCP).
  • Proficiency in Clinical Document Management Systems and tools like eTRAC.
  • Advanced skills in Microsoft Excel and Word.
  • Exceptional attention to detail, communication, organization, and tracking skills.
  • Proven ability to lead globally distributed, multicultural teams.
  • Networking skills and experience training colleagues.

Additional Information

All your information will be kept confidential in compliance with EEO guidelines.