3.0 - 5.0 years

0 Lacs

india

On-site

JOB DESCRIPTION About The Role: The Trial Master File (TMF) Specialist will serve as a subject matter expert and primary point of The Trial Master File (TMF) Specialist will serve as a subject matter expert and primary point of contact for activities associated with ensuring the TMFs meet all applicable Good Clinical Practice (GCP) guidelines, regulatory requirements and Standard Operating Procedures (SOPs). Oversee end to end TMF management and support cross functional TMF users including driving innovative solutions related to trial master file management and TMF system usage. Collaborate with internal stakeholders to manage study specific TMF structure, system integrations and upgrading n...

Posted 1 day ago

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Associate Director, TMF Compliance Lead Bristol-Myers Squibb

10.0 - 14.0 years

0 Lacs

hyderabad, telangana

On-site

As a Senior Manager, Trial Master File (TMF) Operations at Bristol Myers Squibb, you will play a crucial role in leading and providing strategic direction across R&D functions to ensure high-quality TMF end-to-end processes for in-house and outsourced studies. Your responsibilities will include: - Leading and providing strategic direction across R&D functions for high-quality TMF end-to-end processes - Managing TMF Process Leads and TMF System and Business Lead - Defining TMF migration strategies in collaboration with business stakeholders - Ensuring document management and archival processes are of high quality and in line with industry standards - Leading global, cross-functional projects ...

Posted 1 month ago

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Senior Manager - TMF Team Lead AstraZeneca

5.0 - 7.0 years

0 Lacs

bengaluru, karnataka, india

Remote

Title - Senior Manager - TMF Team Lead Work Location: Manyata Tech Park, Bangalore, India Work Schedule: Three days on-site, two days remote (3/2) Work Hours: 9 am to 6 pm IST or 2 pm to 11 pm IST basis business needs (Transport available as per company policy) Career Level: E - Team Lead About Role The GBS TMF Team Lead is responsible for the strategic oversight, coordination, and leadership of the GBS TMF Services, ensuring high standards in Trial Master File management and inspection readiness for all assigned clinical trials. This role supervises TMF Managers, and Coordinators, fosters cross-functional collaboration, implements process improvements, and ensures compliance with global reg...

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Associate Director, TMF Process, Systems and Training Premier Research

15.0 - 19.0 years

0 Lacs

karnataka

On-site

Premier Research is seeking an Associate Director, TMF Process, Systems, and Training to join the Pharmacovigilance and Records Management team. In this role, you will play a pivotal part in assisting biotech, medtech, and specialty pharma companies in translating groundbreaking ideas and scientific advancements into new treatments. Your work will directly impact saving and enhancing lives, highlighting the invaluable contribution of our team members towards achieving success. As an essential member of our team, you will be instrumental in driving the improvement of TMF processes, systems, and training within Global Records Management (GRM). Collaborating with Departmental Leadership, you wi...

Posted 3 months ago

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TMF Study Owner Phlex Recruit

2.0 - 6.0 years

0 Lacs

delhi

On-site

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Posted 4 months ago

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Manager, Clinical Operations Kenvue

7.0 - 11.0 years

0 Lacs

karnataka

On-site

As the Manager, Clinical Operations at Kenvue, you will be responsible for coordinating the operational aspects of Higher complexity clinical studies for Consumer Health products in India, APAC, or EMEA. Your role will involve collaborating with key stakeholders within the Clinical Operations global organization, local India leadership, Study directors, Clinical IT, and Bioresearch Quality & compliance (BRQC). Your primary responsibilities will include leading operational aspects of clinical studies, ensuring compliance with ICH GCP guidelines, company SOPs, and local regulations. You will serve as the point of contact for local projects funded by India R&D, participate in pipeline planning,...

Posted 4 months ago

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