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Job Title: 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 Overview: Provides leadership of the centralized monitoring team, in partnership with project and clinical lead, and in collaboration with other functional teams, to achieve the delivery of the project’s overall objectives to the sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our standard operating procedures, policies and practices. Facilitate efficient and effective review of Site Visit Reports and assure consistent standards of implementation for quality to meet or exceed quality standards. To provide expertise support in the Centralized monitoring studies from Applications, Analytics and Therapeutics or Quality perspective. 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. Act as lead for the reviewers performing Subject Level Data Review, create plans and Act as Subject Matter Expert to support the CMS department in delivering trainings, perform periodic review of Centralized monitoring trainings. Act as mentor or coach for Technical solution Specialist (TSS).; Monitor site performance and make recommendations for timely corrective actions. 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. Strong written and verbal communication skills including good command of English language. Results and detail-oriented approach to work delivery and output. Understanding of clinical/medical data. Good motivational, influencing, negotiating, and coaching skills. Ability to work on multiple projects and manage competing priorities. In depth therapeutic and protocol knowledge. Demonstrated ability to deliver results to the appropriate quality and timeline metrics. Ability to work across cultures and geographies with a high awareness and understanding of cultural differences and maintain effective working relationships with coworkers, managers, and clients. Educational Qualification: Bachelor's Degree bachelor’s degree in clinical, life sciences, mathematical sciences, or related field, nursing qualification or allied medical degree. Show more Show less
