Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
The Senior Director, Clinical Data Management (CDM) Operations is responsible for the operational performance of the CDM Department. S/he will report to the Head of CDM, and collaborate closely with the Director of Clinical Data Innovation, and fulfil the following job functions:
- Responsible for the supervision and management of all CDM operational staff, including hiring, motivating, training, coaching/mentoring, and performance evaluation; provide CDM staff with reliable guidance to succeed and grow.
- Develop department budgets and staffing requirements in collaboration with the Head of CDM and the Director of Clinical Data Innovation
- Accountable for CDM timelines, deliverables, quality, and budget adherence across the portfolio.
- Plan and adapt resources as needed to ensure key goals are met on time.
- Communicate corporate and project objectives to CDM staff in a clear and timely manner.
- In collaboration with the Head of CDM and the Director of Clinical Data Innovation, develop department goals and ensure connection to personal goals of CDM staff in support of the corporate objectives.
- Ensure all aspects of the company's clinical data management processes and procedures are consistent with current industry practices and meet all pertinent regulatory requirements, both domestic and international.
- Develop departmental SOPs, Work Instructions, Best Practice Documents and guidelines; periodically assess the need to revise these documents.
- Serve as an authority in the design and implementation of clinical data management strategies.
- Ensure appropriate input from the operational CDM perspective to the selection of Contract Research Organizations (CROs) and other vendors in the clinical trials space
- Serve as primary interface with vendors and other departments in the area of clinical data management; provide guidance and monitor the progress of CDM activities with CROs and other vendors.
- Contribute to strong cross-functional relationships through frequent interactions and solid communication skills.
- Maintain current professional knowledge in fields of information management, computer science, quality assurance, regulatory affairs, and applicable areas of medical sciences.
- Be able to provide hands-on involvement in the planning, execution, and maintenance of major projects as necessary.
- Serve as a member of the GCDO Leadership team
- BA/BS or equivalent experience, preferably in the scientific/health care field
- At least 15 years of experience in CDM for the pharmaceutical/biotechnology industry with demonstrated ability and experience in all aspects of CDM processes and their relationship to Clinical Research & Development
- Solid leadership experience and the ability to hire and develop staff
- Experience managing CROs
- In-depth knowledge of regulatory guidelines (e.g. ICH, GCDMP, 21 CFR Part 11), industry trends, and their application to DM practice
- Solid understanding of different Data Management systems and technologies, Electronic Data Capture systems, and CDISC data standards
- Strong consultative, listening and analytical skills
- Strong English language written and verbal communication skills
- Able to travel as needed. Up to 20%
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and 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.