Sr Manager - Medical Data Review

Job description

### Job Summary Senior Manager - Medical Data Review Company - Global Business Services, India Department - Central Monitoring Unit Location - Bangalore, India Are you ready to shape the future of clinical trial oversight and drive medical data quality at a global scale? Join us in Bangalore to lead a team of expert medical reviewers, advance Risk-Based Quality Management (RBQM), and ensure that the data behind life-changing therapies is robust, reliable and patient-focused. ### Your new role As Senior Manager of CMU-BLR Medical Data Review, you will plan and oversee the medical monitoring aspect of clinical trials while leading a team of dedicated professionals. You will hold operational leadership responsibility across clinical development programs, ensuring data integrity, patient safety and regulatory compliance through a quality-by-design approach. Day-to-day your tasks will include: - Driving and overseeing clinical trial medical monitoring planning and execution in line with RBQM principles, GCP and SOPs and also ensuring medical data consistency and laboratory data surveillance - Leading, coaching and developing your team setting clear competency and behavioural expectations, conducting performance reviews, and using IDPs to support individual growth - Managing line budgets, allocating resources across trials and projects, and coordinating with peer Managers, Senior Managers and Directors within the RBQM Centralised Monitoring Area - Representing RBQM and Medical Monitoring in cross-functional fora, working groups and steering committees, including Medical Science, Clinical Operations, Data Management and Global Safety - Building strong collaboration with stakeholders across RD internally with CMU GBS, Biostats, Trial Management, RBQM and RD Quality, and externally with CROs, professional associations and regulatory authorities during inspections - Driving strategic initiatives and continuous improvement, identifying process enhancements and keeping the organisation at the forefront of RBQM practice - Ensuring audit and inspection readiness at all times and upholding compliance with local GBS HR, Finance, Legal, Procurement and Quality policies ### Your new department In Research Development, you'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs. ### Your skills qualifications We are looking for an experienced people leader with deep clinical development expertise and a passion for driving quality and innovation. You will bring with you: - An MD degree in science or similar, supported by equivalent professional experience - Minimum 5+ years of management experience both for Senior Manager and 8+ years for Associate Director within the pharmaceutical industry, with strong people leadership skills and the ability to build, develop and inspire diverse teams - In-depth understanding of the global drug development value chain, GxP requirements and external regulatory expectations around risk-based monitoring of clinical data - Proven ability to network and collaborate across functions, cultures and organisational levels, both internally and with external stakeholders such as CROs and regulatory authorities - A proactive, action- and result-oriented mindset, combined with flexibility, cross-cultural awareness and the ability to lead through uncertainty and change - Excellent communication, interpersonal and decision-making skills, with fluency in written and spoken English #### Experience Level Senior Level Disclaimer : This job posting & Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.