Senior Clinical Data Manager

Jazz Pharmaceuticals, Inc.; Royal Borough of Greenwich; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Pension plan

Flexible vacation

Professional growth opportunities

Job summary

Jazz Pharmaceuticals, Inc. in London and globally seeks a Senior Clinical Data Manager to lead data management for Phase 1-4 studies, with a focus on healthy volunteer programs.

You will work with Clinical Pharmacology, Medical Monitoring, Biostatistics, and Phase I Unit teams to ensure timely, inspection-ready data for safety reviews and dose decisions. You will manage complex HV studies (SAD/MAD/first-in-human) and oversee CRO relationships, eCRF design, EDC systems, and data quality.

Qualifications

• Five+ years in Data Management in pharma/biotech with HV Phase I experience.
• Strong knowledge of ICH/FDA guidelines and CDISC standards.
• Excellent communication and ability to work with distributed teams.

Responsibilities

• Lead data management tasks for early and HV studies across phases.
• Represent Data Management on study teams and coordinate with CROs.
• Oversee data management activities and monitor vendor progress.
• Collaborate with cross-functional teams to review emerging safety data in real time.
• Review protocols for data capture and lead EDC/eCRF design/testing.
• Provide training on EDC/eCRF at Investigator Meetings.
• Mentor junior staff and support onboarding.
• Drive process improvements and maintain a professional environment.

Skills

Data management expertise

Project management

Regulatory knowledge (ICH/FDA/CDISC)

Attention to detail

Global collaboration

Education

BA/BS in science or healthcare

Tools

EDC systems

eCRF design

Job description

Join Our Team as a Senior Clinical Data Manager!As 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, planning, leading, and executing Data Management tasks for phase 1-4 studies, with a focus on Phase I Healthy Volunteer (HV) studies.

In this role, you will leverage your broad knowledge of the data management process to perform essential tasks with minimal guidance. You will collaborate closely with Clinical Pharmacology, Medical Monitoring, Biostatistics, Bioanalytical, and Phase I Unit personnel to ensure timely, accurate, and inspection-ready data is available to support safety reviews, dose escalation decisions, and overall study conduct.

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), Multiple Ascending Dose (MAD), and first-in-human studies.
• Represent Data Management on the study team for assigned studies.
• Manage and monitor data management activities and vendor progress, building effective relationships with CRO counterparts.
• Collaborate with various teams to support real-time review of emerging safety and clinical data.
• Review protocols for data capture requirements, ensuring appropriate electronic Case Report Form (eCRF) design.
• Lead the design and testing of Electronic Data Capture (EDC) systems and resolve any issues.
• Provide training on EDC and eCRF Completion Guidelines at Investigator Meetings.
• Mentor junior Data Management staff and assist with onboarding new team members.
• Contribute to process improvement initiatives and maintain a professional working environment.

What You Bring

• At least five years of experience in Data Management within the pharmaceutical/biotechnology industry, including two years leading Phase I (HV) 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 both independently and collaboratively.
• Excellent communication skills and experience working with globally distributed teams.
• Knowledge of reconciliation and quality review processes for clinical data.
• A solid educational background, preferably a BA/BS in a scientific or healthcare field.

Welcome to Jazz Pharmaceuticals, a global biopharma company on a mission to innovate and transform the lives of patients and their families. We are dedicated to developing life-changing medicines for individuals facing serious diseases, often with limited or no therapeutic options. Our diverse portfolio includes leading therapies for sleep disorders, epilepsy, and a growing range of cancer treatments. With a patient-focused and science-driven approach, we are pioneering advancements in oncology and neuroscience. Headquartered in Dublin, Ireland, we have research and development laboratories, manufacturing facilities, and dedicated employees across multiple countries, all committed to serving patients worldwide.

Why Join Jazz Pharmaceuticals?

• Comprehensive medical, dental, and vision insurance.
• Retirement savings plan to help you secure your future.
• Flexible paid vacation to maintain a healthy work-life balance.
• Opportunities for professional growth and development.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Ready to make a difference? Join us in our mission to transform lives!