Job Description

Summary #LI-Hybrid Location: Hyderabad, India
Are you passionate about driving excellence in clinical study management? As Manager, GMA Study Management Excellence, you'll play a vital role in shaping the future of global medical affairs by ensuring robust demand forecasting, resource planning, and budget management for all studies. You'll collaborate across teams to streamline processes, enhance performance, and uphold the highest standards of compliance, directly impacting the success of medical programmes and patient outcomes worldwide.

Responsibilities:
Set up and maintain demand forecasting and management processes for all studies based on the GMA EG Book of Work.
Ensure all planned, ongoing, and completed studies are accurately tracked in the GMA EG Book of Work.
Develop and improve processes and tools for capacity algorithms, demand, and supply management for study lead capacity.
Collaborate with Study Management associates to consolidate study budgets and forecasts for all GMA studies.
Provide timely and accurate budget and capacity reports to relevant stakeholders, including GMA Portfolio and Programme Management.
Identify capacity and budget risks early and support the development of mitigation strategies.
Report progress and mitigation plans to leadership, ensuring transparency and accountability.
Support internal audits and Health Authority inspections, ensuring no critical findings in assigned functions.
Ensure Corrective and Preventive Action (CAPA) plans are implemented and closed on time.
Drive process simplification, performance improvement, and a sustainable compliance mindset across teams.
Essential for the role:
Bachelor's or master's degree, preferably in life sciences.
Approximately 5 years' experience in capacity planning or resource management, ideally in clinical research within pharma or CRO.
Experience in Medical Affairs is preferred.
Strong understanding of clinical development activities, functions, and responsibilities.
Advanced knowledge of business processes, relevant regulations.
Experience in budget management and forecasting of clinical studies.
Demonstrated innovation in operational processes and issue resolution.
Strong interpersonal, problem-solving, negotiation, and conflict resolution skills, with experience working cross-functionally in global teams.
Desirable for the role:
Experience in Medical Affairs within a global pharmaceutical company or contract research organisation.
Demonstrated ability to innovate and improve operational processes in a cross-functional, multicultural environment.
Skills Desired Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Internal Medicine, , Medical Information, Organization Skills, Patient Care, Stakeholder Engagement, Tcp/Ip Protocols, Utilization Management (Um)

Skills Required