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Associate Director, Clinical Data Management Systems Integration

Company: Jazz Pharma
Location: Palo Alto
Posted on: October 16, 2020

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 Associate Director of CDM Systems Integration will be the CDM lead for all Jazz Clinical Data Factory (CDF) activities as well as future system selection and onboarding. In this position, the person will work closely with R&D team members within CDM, Clinical Operations, R&D IT Analytics, Clinical Development and Biometrics to develop, implement, standardize, and maintain solutions for the operationalization of clinical trials. This individual may lead 1-2 direct reports. The Associate Director of CDM Systems Integration will report into the Director of Clinical Data Innovation.

Essential Functions

* Manage Jazz CDF and other information systems within CDM and provide architectural, technical, and strategic inputs to multiple projects

* Collaborate with technology teams, System Owners (SO), Business Process Owners (BPO), business end users, and functional leaders to manage implementation of clinical studies within the Jazz CDF and other platforms, training requirements and training content

* Lead, manage, develop, coach and support individuals responsible for training options, user access and technical support in relation to the Jazz CDF and other CDM information systems

* Work with the BPOs and SOs to resolve complex operational problems provide solutions to facilitate the comprehensive adoption and effectiveness of the Jazz CDF

* Cultivate and disseminate knowledge of application-usage best practices

* Determine business needs across the R&D group and translate this into system and end user requirements

* Work with the BPOs and SOs to solve complex problems and analyze potential solutions to ensure GxP compliance and determine and document future needs

* Create and review technology requests for proposals (RFP) and engage in the vendor selection process

* Coordinate with external vendors (in particular eClinical Solutions), SOs and BPOs to manage or support the development of the Jazz CDF and other platforms, including software updates and patch fixes

* Plan, prepare, and implement validation testing processes to ensure that deliverables adhere to system user requirements and GxP requirements

* Maintain CDM's repository of software applications and their integrations through best practices and the appropriate staffing and management of a technical team to support this effort

* Develop and/or implement change management strategies to enhance system adoption across the R&D function

* Perform/assess time and resource estimates for project planning, managing timelines for studies/projects

Required Knowledge, Skills, and Abilities

* 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

* Familiarity with clinical data sets from major EDC systems (e.g., Medidata Rave, InForm, TrialMaster), safety systems (Argus), and CTMS systems.

* 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) Risk Based Monitoring a plus

* Experience with SAS, T-SQL, and Qlik is a plus

Required/ Preferred Education and Licenses

* Required: Bachelor or Master's Degree in Biology, Mathematics, or related fields

* Preferred: 10 years in a clinical trial role including 3 years minimum of line management and leadership responsibilities.

Description of Physical Demands

* Occasional mobility within office environment.

* Routinely sitting for extended periods of time.

* Constantly operating a computer, printer, telephone and other similar office machinery.

Description of Work Environment

* Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.

* Frequent computer use at workstation.

* May move from one work location to another occasionally.

* Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.

* Occasional public contact requiring appropriate business apparel.

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.

Keywords: Jazz Pharma, Palo Alto , Associate Director, Clinical Data Management Systems Integration, Other , Palo Alto, California

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