Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Tmf Specilaist

Icon
ICON
2+ years
Not Disclosed
10 Oct. 17, 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

About the Role

As a TMF Specialist, you will be joining the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence.

Key Responsibilities:

  • Ensure the consistent receipt, analysis, classification, registration, filing, and retrieval of electronic clinical trial essential and non-essential documents, along with other clinical trial-related documents.
  • Index documents in eTMF Veeva Vault with the required metadata.
  • Perform peer reviews to ensure that documents are in their final state.
  • Send rejection notifications using Microsoft Forms and communicate updates to the sender via email.
  • Run inactivation and reclassification reports and complete necessary tasks as needed.
  • Coordinate communications regarding the progress and completion of study documentation, package creation, and data entry activities across various functional areas.
  • Run and analyze reports.
  • Maintain weekly document processing metrics, including errors, returns, and delays, using Excel spreadsheets.
  • Oversee the processing of study document requests from cross-functional team members, ensuring all urgent requests and inquiries are addressed promptly.
  • Provide process training and mentoring to new RMSs.
  • Offer QC and audit support.
  • Coordinate, lead, and execute tasks related to weekly submission error reconciliation processes and report on completion and error metrics.
  • Coordinate, lead, and execute the QC process as per sponsor QCP, reporting on quality metrics for the team and individuals while communicating error trends and QC metrics.
  • Monitor, track, and report on rework and reclassification requests.

Qualifications:

  • 2 to 4 years of experience in a pharmaceutical or contract research organization.
  • Ability to interact effectively with Clinical and Regulatory teams regarding the receipt, analysis, classification, and disposition of documents.
  • Demonstrated knowledge of essential clinical trial documentation.
  • Strong verbal and written communication skills in English and local language.
  • Exceptional attention to detail and the ability to multitask.
  • Proven problem-solving, time management, and organizational skills.