3 Study Protocol Jobs

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5.0 - 9.0 years

0 Lacs

vadodara, gujarat

On-site

As a candidate for this position, you will be responsible for working in compliance with cGMP guidelines and SOPs. Your primary focus will be aligning with the organization's goals and carrying out any additional responsibilities assigned by your reporting authority. Key Responsibilities: - Perform instrument calibration and maintain instruments/equipment according to SOPs - Follow safety precautions outlined in laboratory procedures - Conduct method development studies for Drug Substance, Drug Product & In-process Materials related to Peptides - Perform method validation studies for Drug Substance, Drug Product & In-process Materials related to Peptides - Analyze routine samples and stabili...

Posted 1 day ago

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1.0 - 4.0 years

12 - 18 Lacs

gandhinagar, ahmedabad

Work from Office

Job Summary The Medical Monitor will serve as the primary medical expert for late-phase (Phase IIIV) clinical trials, ensuring subject safety, scientific integrity, and regulatory compliance throughout the study. This role involves providing ongoing medical oversight, safety data review, protocol compliance assessment, and guidance to investigators and the clinical team. The Medical Monitor acts as the key medical contact for study teams, sites, sponsors, and regulatory authorities. Key Responsibilities Provide continuous medical and scientific oversight for late-phase clinical studies. Ensure subject safety through regular review of adverse events, SAEs, and safety signals. Conduct medical ...

Posted 1 week ago

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6.0 - 10.0 years

6 - 13 Lacs

Hyderabad

Work from Office

Role & responsibilities Support Preclinical Development Strategy Assist in devising and implementing preclinical development strategies for new drugs or generics, including literature review and assimilation of relevant scientific data. Contribute to the design and planning of in vivo and in vitro studies, ensuring alignment with regulatory and therapeutic goals. Study Management and Oversight: Coordinate and support the execution of pharmacodynamics, pharmacokinetics, and toxicological studies, often at contract research organizations (CROs). Verify test article characterization data and review preclinical study protocols, data, and reports for accuracy and compliance. Ensure timely executi...

Posted 3 months ago

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