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TMF Lead

Chennai, TN
Job Code:
  • Biotechnology & Science
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Job Details

Overview of the RoleYou will be responsible to ensure a complete and accurate Trial Master File through documentation quality and consistency across programs.You will determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress.Role RequirementsYou will possess a Bachelor s Degree or equivalent degree/experience.You must have clinical documentation management and industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations.You must have project management, resource management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.You must have experience supporting regulatory submissions and inspections preferred. Strong skills in negotiation and conflict resolution essential too.You will assess impact of potential changes to TMF specifications prior to implementation and collaborating with CPM if modifications are necessary. You will review audit reports and document metrics for trends and to ensure that program document management deliverables are on target.You will serve as a point of contact for providing responses to regulatory authorities with regard to documentation management activities for audits, regulatory submission issues and product defense.
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 3-8


Clinical Research | Documentation/ Medical Writing
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