Posted:1 week ago|
Platform:
Hybrid
Full Time
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
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