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Associate Director Clinical Data Management Systems Integration

ixoop Technologies Palo Alto, CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Associate Director, Clinical Data Management Systems Integration

Work location: remote starting, it would be onsite later (local candidate or available to relo required)

Palo Alto, CA, US - MUST be willing to work onsite. Relocation expenses will be paid for the right candidate.

Phone and Video interview required

Direct Hire: $160K to $195K

Fee: 8 to 10% of Annual Salary

Is relocation available? Yes, nationwide;

Is there additional variable compensation? 20-25% Target Bonus;

There is a possibility for sponsorship. Yes;

Is this a new position, or a backfill? New Position;

There is equity in this position. Yes;

This position has direct reports. Yes;

Describe how this position fits in your organization.

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;

What are the 3-4 non-negotiable requirements of this position?

Must be able to work on site when our offices reopen. Required: Bachelor or Master's Degree in Biology, Mathematics, or related fields 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;

What are the nice-to-have skills?

Knowledge of ICH E6 (R2) Risk Based Monitoring a plus Experience with SAS, T-SQL, and Qlik is a plus;

What is exciting about this opportunity? Please include team and company culture.

* Jazz was literally created to be a great place to work. Our culture is inclusive and dynamic *Two successful launches during an Pandemic and we are one of a few companies that continue to grow during Covid;

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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
  • 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
  • Ability to manage multiple complex projects and assess resource needs
  • Excellent verbal and written communication skills

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.

ixoop Technologies

Address

Palo Alto, CA
94301 USA