Senior Clinical Study Manager – Global Medical Affairs

Job Description Summary

We are seeking a Senior Clinical Study Manager to lead the operational delivery of medium to high complexity Global Medical Affairs studies, including Non-Interventional Studies, Research Collaborations, and Investigator-Initiated Trials. This role ensures excellence in planning, execution, and reporting, while maintaining compliance with quality standards and fostering cross-functional collaboration.

 

Job Description

Key Responsibilities

• Lead cross-functional study teams and lead study execution operations from concept to reporting.
• Oversee study documentation, systems, and vendor/Third Party activities activities and deliverables.
• Track progress, manage budgets, risks, and ensure timely reporting and disclosures.
• Drive process improvements and operational excellence.
• Ensure compliance with process standards for quality and systems, ensure audit readiness.
• Mentor junior team members and contribute to training initiatives.

Qualifications

• Bachelor’s degree or higher in Life Sciences or Healthcare.
• 6+ years in clinical operations or project management (pharma/CRO).
• Strong knowledge of GCP and global clinical development.
• Proven leadership in matrixed environments.
• Excellent communication, strategic thinking, and stakeholder engagement skills.
• Fluent in English.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

 

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, Job Description, Medical Information, Organization Skills, Patient Care, Stakeholder Engagement, Tcp/Ip Protocols, Utilization Management (Um)