Trial Master File (TMF) Lead

Dr. Reddy's Laboratories Ltd

Lead TMF setup, maintenance, and close-out of various studies eTMF system as per CDISC TMF reference model, SOPs, study-specific processes and applicable regulations.
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Primary point of contact for TMF related activities of assigned studies and responsible for developing successful cross-functional relationships with internal and external stakeholders.
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Own end to end responsibility to completeness, Quality and Timeliness of TMF content for all assigned studies until archival.
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Effectively monitor and report on progress of the TMF to Internal and external customers.
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Oversee TMF document flow within projected timelines.
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Accomplish TMF activities in accordance with the contracted budget for TMF Management (As applicable for insourced or outsourced studies).
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Develop and cultivate CRO relationships through effective communication.Apply lessons learned to continuous improvement of documentation management practices across study teams.
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Provide feedback and guide Study Teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials.
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Assess impact of potential changes to TMF specifications prior to implementation; collaborate with Project Leads and/or designee if modifications are necessary.
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Maintain Study Document Lists at the study, country and site levels by collaborating with all relevant Functional heads to ensure the placeholders are correctly and accurately in place for the study and all versions of documents are filed in a timely manner.
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Conduct periodic quality review of Study Document Lists at all levels and liaise with the Document Owners to ensure that all findings are addressed and remediated in a timely manner
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Primary point of contact for internal and external audits of study TMF-related queries and support the preparation of appropriate audit and inspection responses.

Post Graduate in Science, Pharmacy or Medical Degree