Clinical Data Systems Implementation Lead
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AI Summary
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
Oversight of activities
Program moderately complex data review listings, exception reports, and metrics reports in a fast-paced environment for clinical trial data review and management purposes
Contribute to the development of software systems and related infrastructure to generate displays of clinical study data and metrics reports that are efficient and user-friendly
Create and document archives of software and deliverables
Support company’s CDF and other platforms, including software updates and patch fixes Collaborative relationships
Provide time and resource estimates for project planning as well as accurately record time spent on multiple deliverables
Responsible for training options, user access and technical support in relation to the company’s CDF and other CDM information systems
Cultivate and disseminate knowledge of application-usage best practices
Responsible for maintaining system and end user requirements documentation
Responsible for implementing solutions to ensure GxP compliance
Support company’s CDF and other platforms, including software updates and patch fixes
Collaborative relationships
Liaise with Clinical Data Management staff to understand the needs of the end users of the listings, reports, and metrics
Compliance with Parexel standards
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
Skills:
Ability to work in a cross-functional team environment
Adept in end-to-end administration emphasis on analysis, development, design, testing and implementation of various projects.
Knowledge and Experience:
Thorough knowledge of clinical trial study design, data collection and the drug development processes
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]
Knowledge of ICH E6 (R2) Risk Based Monitoring a plus
Experience with SAS, T-SQL, and Qlik (preferred)
Minimum of 5 years of relevant experience
Education:
Bachelor’s Degree is required; degree in life science or related discipline preferred.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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