Clinical Data Systems Implementation Lead
Location
United States
Posted
1 day ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Clinical Data Systems Implementation Lead
Parexel
Role Description 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 - 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 Qualifications - 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 Requirements - 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 Company Description 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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• Perform database updates for client data per company procedures • Properly and timely complete all documentation • Create, edit and complete call summaries according to written procedure • Attend and participate in training sessions as scheduled • Provide timely responses to team members • Perform data entry • Maintain client files and appropriate electronic documentation • Be available for meetings as requested • Other duties may be assigned, added and/or removed with the ever-changing technology of A.I.




