- A SaaS solution (elluminate) used for centralized data cleaning, medical/safety reviews, RBQM, and operational oversight of clinical trials, and
- The clinical trial operational data component of an enterprise business intelligence application that utilizes AWS and Tableau
- Develop and lead the execution of strategic roadmap and objectives for the clinical data platform(s)
- Partner cross-functionally to optimize Jazz's use of the clinical data platform(s) and develop/implement change management strategies to maximize adoption
- Provide vision, motivation, leadership, and mentoring to the Clinical Data Innovation team. Plan, hire and adapt resources as needed to ensure key goals are met on time. Provide the team with reliable guidance to succeed and grow.
- Drive strong cross-functional relationships at senior leadership level (particularly with Clinical Operations, Clinical Development, Biostatistics & Statistical Programming, Quality, Finance, IT, and Medical Affairs) through frequent interactions and solid strategic thinking and communication skills; interact effectively with senior leadership when required
- Serve as the primary strategic interface with clinical data platform technology vendor, including but not limited to membership of Steering / Governance committees established with such vendors.
- Maintain and expand current professional knowledge in technology as applied to clinical trials.
- Resolve complex strategic issues in creative and effective ways, within GCDO but also across the broader Clinical Development space
- Determine business needs across the R&D group and translate this into system and end user requirements
- Create and review technology requests for proposals (RFP) for new data and analytics solutions and engage in the vendor selection process
- Coordinate with external vendors to manage or support the development of the data platforms
- Collaborate with IT partners to plan, prepare, and implement testing processes to ensure that deliverables adhere to system user requirements and GxP requirements
- Thorough knowledge of clinical trial study design, data collection and the drug development process
- Ability to manage multiple complex projects and assess resource needs
- Excellent verbal and written communication skills
- Background in designing visualization tools in a clinical trial data visualization environment
- Experience with CDASH standards
- In-depth knowledge of clinical trial planning, start-up, and conduct concepts and challenges that can be supported using data visualizations
- Familiarity with clinical trial data collection systems including CTMS, IRT, EDC and data structures/transfers from those systems
- Experience managing a portfolio of multiple simultaneous projects
- Strong problem-solving skills with an emphasis on solving technical and data problems
- Ability to communicate effectively with technical and non-technical stakeholders at various levels up through senior leadership
- Understanding of clinical data structures, relational database structures, and data exchange
- In depth understanding of regulatory, industry (GCP), and technology standards and requirements [ICH E6 and Regulatory Guidelines and SDLC]
- Strong project management skills and ability to work in a cross-functional team environment
- Knowledge of ICH E6 (R2) a plus
- Experience with Tableau, AWS, T-SQL, and elluminate is a plus
- Bachelor or Master's Degree in Biology, Mathematics, Computer Science or related fields
- 10 years in a clinical trial role including 3 years of line management and leadership responsibilities.
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Manager, GCDO Business
3 weeks ago
Jazz Pharmaceuticals California, United States Full timeBrief Description: · The Manager, GCDO Business & Technology Capabilities demonstrates broad knowledge of the Clinical Development process and the technologies, systems, and applications that support this. The role is responsible for the design, development, production, delivery ...
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Manager, GCDO Business
4 weeks ago
Jazz Pharmaceuticals california, United Statesp>If you are a Jazz employee please apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing med ...
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Jazz Pharmaceuticals california, United Statesp>If you are a Jazz employee please apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing med ...
Associate Director, Clinical Data Innovation, GCDO Business - California, United States - Jazz Pharmaceuticals
Description
Brief Description:
The Associate Director, Clinical Data Innovation is responsible for overseeing all personnel, processes, and technologies that comprise the data and analytics platforms used by the Jazz Global Clinical Development Operations (GCDO) department. The two platforms currently are:
The Associate Director, Clinical Data Innovation will lead a team of professionals that manage, configure, and program on these platforms, and will be expected to provide vision, leadership, and mentoring to that team. S/he will facilitate effective internal cross-functional and external vendor and industry relationships. S/he will be expected to contribute extensively to the development and growth of the group within the GCDO structure. S/he will fulfil the following essential functions, and may also be assigned to other duties as assigned by the Head of Business & Technology Capabilities.
Essential Functions/Responsibilities
Required Knowledge, Skills, and Abilities
Required/Preferred Education and Licenses
FOR US-BASED CANDIDATES ONLY