Centralized Monitoring Lead

Project role

Work experiences

Work locations available

Mode of work

Shift

Must have skills

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 standard. 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.