Clinical Research Manager
3 days ago
About the job
Who We Are:
For over 5 decades now, we at Bharat Serums and Vaccines Ltd. have used our scientific resources to develop a range of biological, biotech and pharmaceutical products. Advent International, a global PE firm has endorsed its faith in our commitment towards bringing life to life and is partnering with us on an ambitious growth journey.
We seek individuals who can enhance our team with their knowledge, skills, creativity and teamwork.
Key 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.
- This profile involves around 20% of travelling.
- Candidates with relevant experience and open to travel only apply.
- Candidate must have exp in Clinical Trials followed by Project management.
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