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Bharat Serums and Vaccines
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Manager - Clinical Research and Pharmacovigilance

Manager - Clinical Research and Pharmacovigilance

Bharat Serums and Vaccines

10 - 13 years

|

10 - 12 Lacs

navi mumbai airoli

Posted:4 hours ago| Platform:

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Skills Required

clinical research clinical trials patient trials project management gcp pharmacovigilance ich

Work Mode

Work from Office

Job Type

Full Time

Job Description

Must have exp in Clinical Trials followed by Project management

Role & responsibilities

Ensuring management of trials are 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 to 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 appropriate final disposition of IMP.
Ensuring clinical study site close-out in accordance with local regulations and ensure 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.

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