Clinical Trial Manager

Overview

The Clinical Trial Manager leads planning, execution, oversight, and delivery of early phase clinical trials, serving as the operational leader for assigned studies.

What you'll do

• Lead operational execution of assigned domestic or global early phase clinical trials and oversee selected vendors/CROs.
• Develop and manage study timelines, contract/budget negotiations, and risk mitigation plans to meet delivery and financial goals.
• Initiate and manage request for proposal activities for clinical development vendors (including CROs and specialty labs/bioanalytical vendors).
• Oversee a cross-functional execution team and manage vendors according to vendor oversight plans.
• Oversee study-level data monitoring activities, including review of monitoring visit reports and sponsor oversight monitoring visits as required.
• Perform monthly protocol deviation (PD) review, including CRA documentation oversight and collaboration with a Medical Monitor.

What you'll need

• Bachelor’s degree in Life Sciences, Data Science, Computer Science, or related field.
• Minimum 10 years’ experience in pharmaceutical/biotechnology (including CRO, pharma/biotech, or clinical research environment).
• At least 5+ years of clinical project/trial management (PM) or equivalent clinical operations experience.
• Knowledge of international regulatory requirements including FDA, EMA, GCP, GMP, and GDPR.
• Ability to ensure trials are executed in compliance with ICH/GCP guidelines, regulations, and applicable SOPs.
• Experience and responsibility for audit/inspection readiness for clinical trial documentation (e.g., central clinical files, TMF, registry submissions).

Nice to have

• 5+ years’ experience in early phase clinical trial management conducted in the US and India.
• Broad understanding of regulatory GMP requirements for IMP product packaging and supply.

Details

• Location: Hyderabad, IN.