Clinical Data Systems Implementation Lead

Parexel • United States-Kentucky-Remote, KY

20h

About The Position

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.

Requirements

• 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.
• 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]
• Minimum of 5 years of relevant experience
• Bachelor’s Degree is required

Nice To Haves

• Knowledge of ICH E6 (R2) Risk Based Monitoring a plus
• Experience with SAS, T-SQL, and Qlik (preferred)
• degree in life science or related discipline preferred

Responsibilities

• 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
• 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
• Liaise with Clinical Data Management staff to understand the needs of the end users of the listings, reports, and metrics
• 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

Benefits

• Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry.
• Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere.
• Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process.
• Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level