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 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)
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