Trial Master File (TMF) Lead

• 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.
• Primary point of contact for TMF related activities of assigned studies and responsible for developing successful cross-functional relationships with internal and external stakeholders.
• Own end to end responsibility to completeness Quality and Timeliness of TMF content for all assigned studies until archival.
• Effectively monitor and report on progress of the TMF to Internal and external customers.
• Oversee TMF document flow within projected timelines.
• Accomplish TMF activities in accordance with the contracted budget for TMF Management (As applicable for insourced or outsourced studies).
• Develop and cultivate CRO relationships through effective lessons learned to continuous improvement of documentation management practices across study teams.
• Provide feedback and guide Study Teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials.
• Assess impact of potential changes to TMF specifications prior to implementation; collaborate with Project Leads and/or designee if modifications are necessary.
• 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.
• 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
• Primary point of contact for internal and external audits of study TMF-related queries and support the preparation of appropriate audit and inspection responses.

Qualifications :

Post Graduate in Science Pharmacy or Medical Degree

Additional Information :

About the Department
Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 1015-year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas covering US$80 Bn in innovator sales future business pipeline covers a variety of product classes and therapy areas and new modalities. Fully integrated organization with over two decades of experience in developing manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities in-house clone development upstream and downstream process development bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900000 patients having benefited from our products till date.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at  Work :

No

Employment Type :

Full-time