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!
#J-18808-Ljbffr…