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Executive Director, Clinical Data Management

Company: Jazz Pharma
Location: Palo Alto
Posted on: January 13, 2021

Job Description:

Overview: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. Responsibilities:The Executive Director, Clinical Data Management functions as the head of the Clinical Data Management (CDM) Department, and collaborates with the VP of Global Clinical Development Operations (GCDO) and within the GCDO Leadership Team (GCDO LT) to drive operational strategy across GCDO. Essential Functions* Be accountable for the management of all CDM staff, including hiring, training, coaching/mentoring, and performance evaluation of direct reports, and motivating, guiding, and maintain an environment in which all CDM staff can succeed and grow.* Approve department budgets and staffing requirements.* Work through the CDM Leadership Team (CDMLT) and CDM Senior Staff (CDMSS) to 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.* Collaborate with GCDO LT and CDMSS to develop department goals in support of the corporate objectives.* Collaborate with CDMLT to ensure that all aspects of the company's clinical data management processes, procedures and technology are consistent with current industry practices and meet all pertinent regulatory requirements, both domestic and international.* Approve departmental SOPs, guidelines, and technical documents. Periodically assess the need to revise these documents.* Proactively assess and make recommendations regarding the development and use of appropriate tools to further support and strengthen the company's development capabilities.* Serve as an authority in the design and implementation of clinical data management strategies.* Member of GCDO Leadership Team.* Collaborate with the VP of GCDO and within the GCDOLT to develop, drive, and where necessary implement a strategy of operational excellence across GCDO* Provide a strong cross-functional influence and leadership presence across Clinical Research & Development.* 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.* Serve as the CDM representative in the Protocol Planning Working Group (PPWG) and Protocol Review Committee (PRC), and represent GCDO where designated by the VP GCDO.* Be able to provide hands-on involvement in the planning, execution, and maintenance of major operational excellence projects, if necessary.Minimum Requirements* BA/BS or equivalent experience, preferably in the scientific/health care field * At least 15 years of experience in the CDM area of the pharmaceutical/biotechnology industry* Solid understanding of different Clinical Data Management processes, systems and technologies, Electronic Data Capture systems, and CDISC data standards* 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 leadership experience and the ability to hire and develop staff * Strong consultative, listening and analytical skills* Strong English language written and verbal communication skills* Able to travel as neededJazz 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.

Keywords: Jazz Pharma, Palo Alto , Executive Director, Clinical Data Management, Executive , Palo Alto, California

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