Senior Clinical Study Manager – Global Medical Affairs

Resumeset; Dublin; On-site; EUR 70,000 - 90,000; Full time

Job summary

A pharmaceutical company is seeking a Senior Clinical Study Manager in Dublin to lead the operational delivery of medical affairs studies. Responsibilities include managing study execution from concept to reporting, overseeing documentation, and ensuring compliance with quality standards. Ideal candidates should have over 6 years of clinical operations experience, strong GCP knowledge, and demonstrate effective leadership. This full-time role focuses on fostering collaboration and driving process improvements within the team.

Qualifications

• 6+ years in clinical operations or project management (pharma/CRO).
• Strong knowledge of Good Clinical Practice (GCP) and global clinical development.
• Proven leadership in matrixed environments.

Responsibilities

• Lead cross‑functional study teams and study execution operations from concept to reporting.
• Oversee study documentation, systems, and vendor/Third Party activities and deliverables.
• Drive process improvements and ensure compliance with quality standards.

Skills

Leadership

Project management

Stakeholder engagement skills

Communication

Strategic thinking

GCP knowledge

Education

Bachelor's degree or higher in Life Sciences or Healthcare

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.

About the Role

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.

Details

Division: Development

Business Unit: Innovative Medicines

Location: Ireland

Site: Dublin (NOCC)

Company / Legal Entity: IE02 (FCRS = IE002) Novartis Ireland Ltd

Alternative Location 1: Barcelona Gran Vía, Spain

Alternative Location 2: London (The Westworks), United Kingdom

Functional Area: Research & Development

Job Type: Full time

Employment Type: Regular

Shift Work: No