Manager Clinical Research | Bharat Serums | Mumbai
Job Overview
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Date PostedAugust 5, 2023
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Location (State / UT)
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Expiration dateFebruary 6, 2025
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Experience7 Years, 10 Years
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GenderAny
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Desired QualificationMaster’s Degree
Job Description
Roles and Responsibilities:
- Ensuring management of trials is done in compliance with ICH, GCP, BSV standards, local laws, and regulations.
- Providing guidance and oversight to CROs.
- Ensuring clinical trials are effectively executed and completed within budget, timelines, and meeting enrolment commitments. Pro-active trial management to identify challenges, develop effective mitigation plans and appropriately escalate and inform all relevant parties.
- Oversee drug and clinical supplies management to ensure sites have timely availability of required materials to avoid disruption of protocol deliverables and to oversee the appropriate final disposition of IMP.
- Ensuring clinical study site close-out in accordance with local regulations and ensuring dissemination of clinical trial results to the participating study investigators. Oversee appropriate file archiving of all relevant study materials in accordance with local laws and guidelines.
This profile involves around 20% of traveling
Candidates with relevant experience and open to travel only apply
Qualification: MS/M.Sc(Science), M.Pharma
Location: Navi Mumbai
