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Jobs/CRO Role/ClinChoice - Data Manager (Permanent role )
ClinChoice

ClinChoice - Data Manager (Permanent role )

United States1mo ago
In OfficeMidNAMedical DevicesPharmaceuticalsCROData AnalystCROTeam ManagementPerformance ReviewsReportingOracle

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Requirements

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field • 3–5 years of experience in clinical data management within CRO/pharma • clinical data management within CRO/pharma • Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle Clinical, Inform) • EDC systems • Strong understanding of GCP, ICH guidelines, and clinical trial processes • GCP, ICH guidelines • Familiarity with CDISC standards (SDTM) • CDISC standards (SDTM) • Good knowledge of data validation and query management • data validation and query management • Strong attention to detail and problem-solving skills • The Application Process • Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. • Who will you be working for? • ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. • Our Company Ethos • Our Company Ethos • Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

Responsibilities

• Manage end-to-end clinical data management activities for assigned studies • clinical data management activities • Design and review CRFs (Case Report Forms) and edit checks • CRFs (Case Report Forms) • edit checks • Oversee data collection, cleaning, and validation processes • data collection, cleaning, and validation • Perform data review and discrepancy management • data review and discrepancy management • Coordinate with cross-functional teams (Clinical, Biostatistics, Programming) • Ensure compliance with CDISC standards and regulatory guidelines • CDISC standards • Support database build, UAT testing, and database lock activities • database build, UAT testing, and database lock activities • Generate and review data listings and reports • data listings and reports • Participate in data reconciliation (e.g., SAE, lab data) • data reconciliation • Ensure timely delivery of high-quality datasets for analysis and submission

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