Senior TMF Associate

Thepharmadaily LLP
  • Posted On: 2025-08-22 20:57:16
  • Openings: 10
  • Applicants: 0
Job Description
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
 
The Clinical Document Management Specialist will be responsible for managing the electronic Trial Master Files (eTMF) for clinical studies, ensuring they remain in an audit-ready state and compliant with regulatory and quality standards. This role involves document classification, review, and deletion processes within the eTMF system, while maintaining close collaboration with study teams and other departments.
 
Summary of Responsibilities:
 
As a Clinical Document Management Specialist at Fortrea, you will oversee key aspects of document management throughout the lifecycle of clinical trials, ensuring the proper handling of clinical study documents in accordance with regulatory requirements and industry standards.
  • Document Classification and Review: Manage the document classification under Smart Inbox, ARC review, and deletion processes for clinical trials. This includes ensuring all clinical study documents (trial, country, and site artifacts) are uploaded, classified, and reviewed correctly in the eTMF system.
  • Audit Readiness: Ensure that the eTMF is maintained in a state of audit readiness by performing visual quality checks on e-documents before they are released, ensuring clarity and readability, and conducting audit-ready checks on each document uploaded to ensure it is contextually accurate.
  • Regulatory Compliance: Process and track essential artifacts throughout all phases of the study in alignment with company SOPs, sponsor SOPs, Good Clinical Practice (GCP), and International Council for Harmonisation (ICH) guidelines.
  • Operational Issue Resolution: Identify and resolve any operational issues related to the TMF, ensuring the proper preparation for internal and client audits. Implement corrective actions in response to audit findings.
  • Collaboration and Communication: Work closely with internal teams and external partners to ensure client satisfaction and to support the timely and efficient completion of clinical trials.
  • Training and Mentorship: Provide training and mentorship to other team members, supporting continuous improvement and knowledge sharing.
  • Business Process Improvement: Contribute to business improvement initiatives focused on driving quality, enhancing productivity, and streamlining processes.
  • Meeting Participation: Attend internal and external study team meetings as required to support the project s documentation needs.
Qualifications: Minimum Required Qualifications:
  • Education: Bachelor s Degree in Life Sciences, Business, or a related field.
  • Experience: A minimum of 3 to 6 years of experience in a clinical research environment, with a solid understanding of clinical document management and eTMF processes.
  • Knowledge: Strong understanding of GCP, ICH guidelines, and regulatory/clinical document requirements.
  • Technical Skills: Proficiency in Microsoft Office, web-based applications, Adobe Acrobat Standard, and the ability to apply software tools related to document management, scanning, and eTMF systems.
  • Communication: Excellent interpersonal and communication skills, with the ability to work collaboratively in a team environment.
Preferred Qualifications:
  • Advanced Education: Master s Degree in Life Sciences, Business, or a related field.
  • Experience: Additional experience in clinical electronic systems and eTMF platforms.
  • Knowledge: Familiarity with clinical trial processes, regulatory documents, and audit preparation.
Physical Demands / Work Environment:
  • Travel: Minimal travel required (less than 10%) for Sponsor Kick-Off Meetings, Client Meetings, or as requested
More Info
Full Time
o
Not Disclosed
English
Not Disclosed
Education
Any Graduate
Not Disclosed
Required Skills
CRO Medical billing GCP MedDRA Pharma medical coding Clinical trials clinical development

Contact Details
Thepharmadaily LLP
+91 987654567
info@pharmadaily.in
  • Experience2 years
  • Salary Above 10 LAKHS ANNUALLY
  • Location for Hiring Mumbai
  • Apply Now
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