Clinical Research TMF Document Specialist

Biorasi
Posted

Post Expires

Type

Researcher / analyst

Mumbai, MH Position Summary :

  • Position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), ICH Guidelines and other regulatory guidance documents, relevant regulations  and company's Standard Operating Procedures (SOPs) as appropriate
  • Clinical Document Specialist will provide support to the TMF content owners on one or more clinical programs. This position will work closely with the Study Management Teams (SMT) to ensure that the TMF is kept both current and inspection ready according to company SOPs and applicable regulations.

The core duties and responsibilities of the Clinical Document Specialist include, but are not limited to: Responsibilities:

  • Work directly with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMF
  • Review and classify documents collected from internal and external sources
  • Create, maintain, review, and archive hardcopy TMF
  • Reconcile essential documents in both hard/soft copies to avoid duplication
  • Perform QC and maintenance ofeTMF/TMF for assigned studies
  • Perform data entry and reconciliation in various clinical systems and tracking tools
  • Provide direct TMF support to clinical trial activities conducted by company
  • Follow up on quality findings

Requirements:

  • TMF Clinical Documentation experience highly preferred
  • Demonstrated experience or knowledge with sponsor or CRO clinical research process, including collection of documents at study start-up, during study conduct and close-out
  • Familiarity with international clinical trials, clinical trial documents and document QC process highly desirable
  • Previous experience working independently and efficiently after training/onboarding
  • Strong computer skills (MS Office) including exposure to data/document management systems
  • Must be able to work quickly, prioritize effectively, and show attention to detail
  • Very Good communication and interpersonal skills

More Information

Posted

Post Expires

Type

Researcher / analyst

Mumbai%2C%20India

Mumbai , India