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Associate Director Gma Study Management

8 years
Not Disclosed
10 Nov. 26, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Director – GMA Study Management
Job ID: REQ-10063471
Location: Hyderabad, India | Hybrid
Employment Type: Full-time | Regular

About the Role:
Novartis is seeking an experienced Associate Director – GMA Study Management to lead the strategic planning and execution of Global Medical Affairs (GMA) studies within a designated Disease Area. This pivotal role offers the opportunity to shape evidence generation through non-interventional studies, investigator-initiated trials, and collaborative research initiatives. The Associate Director will drive operational excellence, oversee cross-functional teams, and build strategic partnerships with key stakeholders and institutions worldwide.

This position is ideal for a professional passionate about advancing medical science, with proven expertise in study management within a global, matrixed environment.

Key Responsibilities:

  • Lead the planning, execution, and reporting of all GMA studies within the assigned Disease Area.

  • Ensure timely, budget-compliant, and high-quality delivery of non-interventional and collaborative studies.

  • Collaborate with the Study Management Director on resource allocation, prioritization, and strategic planning.

  • Manage internal and external teams to ensure alignment of capacity and capabilities.

  • Identify potential risks early and implement mitigation strategies, providing updates to leadership.

  • Represent GMA Study Management in PMAT and provide support to TAMAT as required.

  • Oversee CRO selection, contracting, and performance management in coordination with vendor management.

  • Coordinate study communications and prepare materials for review meetings.

  • Foster strategic partnerships with key opinion leaders (KOLs), institutions, and external collaborators.

  • Promote compliance, process simplification, and operational excellence across study operations.

Essential Qualifications & Experience:

  • Master’s degree in Science; PhD or PharmD preferred.

  • Minimum 8 years of experience in clinical trial operations within pharmaceutical or CRO settings.

  • Proven ability to lead international, cross-functional teams in a matrixed environment.

  • Strong knowledge of clinical development, GCP, and global medical affairs processes.

  • Demonstrated expertise in project management, stakeholder collaboration, and strategic planning.

  • Excellent communication, problem-solving, and conflict resolution skills.

Desirable Qualifications:

  • Experience in Medical Affairs and non-interventional study design.

  • Prior involvement in Health Authority inspections or audit readiness activities.

Why Novartis:
At Novartis, advancing patient care requires more than innovative science—it demands a community of dedicated and passionate professionals. Join our global network to collaborate, inspire, and contribute to breakthroughs that change patients’ lives.

Benefits and Rewards:

  • Comprehensive learning and professional development programs

  • Competitive compensation and recognition frameworks

  • Inclusive and supportive global work environment

Accessibility & Accommodations:
Novartis is committed to providing reasonable accommodations for individuals with disabilities. If you require assistance during the recruitment process, contact diversityandincl.india@novartis.com and reference Job ID REQ-10063471.