Senior Clinical Study Manager – Global Medical Affairs

5 days ago

Dublin, Ireland Healthcare Businesswomen’s Association Full time

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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