Senior Clinical Data Manager

Jazz Pharmaceuticals, Inc.; United States; Remote; USD 110,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Retirement savings plan

Flexible paid vacation

Professional growth opportunities

Job summary

Jazz Pharmaceuticals, Inc. is seeking a Senior Clinical Data Manager to drive data management for Phase 1–4 studies across global programs. The role focuses on Healthy Volunteer (HV) studies and collaboration with cross-functional teams.

You will design, implement, and review EDC solutions, mentor junior staff, oversee vendor relationships, and ensure data quality and regulatory compliance. Remote work flexibility is available, enabling contribution to development and commercial projects

Qualifications

• 5+ years in Data Management, incl leading Phase I studies.
• Strong understanding of regulatory guidelines & industry standards (ICH/FDA, CDISC).
• Excellent communication in English, written & verbal.
• Experience with Electronic Data Capture (EDC) systems and clinical pharmacology data.

Responsibilities

• Lead complex clinical studies or related series with minimal guidance.
• Oversee data management activities for early phase HV studies (SAD/MAD).
• Represent Data Management on study teams and manage vendor relationships.
• Collaborate with Medical Monitors, Clinical Pharmacologists, and stakeholders for data reviews.
• Review protocols for data capture requirements and data collection.
• Design and test EDC systems and resolve issues.
• Lead development of data management documents and training on EDC/eCRF guidelines.
• Participate in database upgrades and manage data queries/reconciliation.
• Mentor junior DM staff and drive process improvements.

Skills

PM skills

Attention to detail

English (written)

Data management

Regulatory knowledge

Tools

EDC systems

CDISC standards

Regulatory guidelines

Job description

Position Overview

Senior Clinical Data ManagerAs a Senior Clinical Data Manager, you will play a crucial role in supporting Jazz Pharmaceuticals' commercial and development projects globally. You will be an integral part of a multi-disciplinary team, leading and executing data management tasks for Phase 1-4 studies, particularly focusing on Phase I Healthy Volunteer (HV) studies.

Key Responsibilities

• Lead complex clinical studies or a series of related studies with minimal guidance.
• Oversee data management activities for early phase HV clinical pharmacology studies, including Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies.
• Represent Data Management on study teams and manage vendor relationships effectively.
• Collaborate with Medical Monitors, Clinical Pharmacologists, and other stakeholders for real-time data reviews.
• Review protocols for data capture requirements and ensure appropriate data collection.
• Design and test Electronic Data Capture (EDC) systems, resolving any issues that arise.
• Lead the development of data management documents and provide training on EDC and eCRF guidelines.
• Participate in database upgrades and manage data queries and reconciliation activities.
• Mentor junior Data Management staff and contribute to process improvement initiatives.

What We’re Looking For

• At least five years of experience in Data Management within the pharmaceutical/biotechnology industry, including leading Phase I studies.
• A comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards).
• Strong project management skills with the ability to prioritize multiple tasks effectively.
• Attention to detail and the ability to work collaboratively within a multi-disciplinary team.
• Excellent communication skills, both written and verbal, in English.
• Experience with Electronic Data Capture systems and a solid understanding of clinical pharmacology data.

Working Conditions

This position offers the flexibility of remote work, allowing you to balance your professional and personal life while contributing to meaningful projects.

Why Jazz Pharmaceuticals?

We believe in fostering a supportive and inclusive work environment. As a member of our team, you will have access to:

• Comprehensive benefits, including medical, dental, and vision insurance.
• A retirement savings plan to help you secure your future.
• Flexible paid vacation to recharge and maintain work-life balance.
• Opportunities for professional growth and development.

About Jazz Pharmaceuticals

At Jazz Pharmaceuticals, we are more than just a global biopharma company; we are innovators dedicated to transforming the lives of patients and their families. Our mission is to develop life-changing medicines for those facing serious diseases, often with limited or no therapeutic options. With a diverse portfolio that includes leading therapies for sleep disorders, epilepsy, and a growing range of cancer treatments, we are committed to pioneering research and development in oncology and neuroscience. Headquartered in Dublin, Ireland, our team spans multiple countries, all united in our goal to serve patients worldwide. Ready to make a difference? Read on!

Equal Opportunity Employer

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer. We welcome all qualified applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.