Centralized Monitoring Lead

Project Role: Centralized Monitoring Lead

Work Experience: 4 plus years of CRA and Clinical trials and monitoring.

Work location: Bangalore/Thane/Pune/Ahmedabad/Kochi/Hyderabad

Work Mode: Hybrid/Office Based

Shift: 2.00pm to 11.00pm

Must Have Skills: Onsite / Remote / Risk Based Monitoring, Clinical Research, Clinical trials.

Job Responsibility:

• Oversight of clinical deliverables across all trial phases (start-up to close-out).
• Development and review of study management plans, risk assessments, and analytics strategies. • Monitoring of site performance, key risk indicators (KRIs), and operational triggers. Financial oversight including budget tracking and investigator payments.
• Coordination of cross-functional teams to meet project milestones.
• Quality assurance through regular audits, documentation, and compliance checks.
• Leading data review processes and ensuring audit readiness at all times.
• May require taking up Clinical lead activities, Manage Finance related information (budget, CO etc.),
• Manage project resources (CRAs/CTAs/Centralized monitoring team), Conduct periodic review of site activities

Technical Skills:

• Requires minimum of 5 years of relevant experience or Medical degree with a minimum 4 years of clinical trial experience or equivalent combination of education, training and experience.
• Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements. i.e., International Conference on Harmonisation - Good Clinical Practice (ICH GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.
• Good Clinical system expertise