Data Management Contractor

Our client is looking to fill the role of Data Management Contractor. This position will be fully remote.Responsibilities:Management and oversight of all aspects of Data Management for development projects as well as management of Data Management vendors globally.Strong understand of regulatory requirements (ex.ICH/GCP) and connection to data quality and data integrity.Strong working knowledge of coding (MedDRA and WHO drug dictionaries).Strong familiarity with CDISC (CDASH/SDTM).Strong knowledge of EDC systems, specifically Medidata RAVE.Good understanding of SAS programming.Knowledge of BI Tools, e.g. Tableau.Work with global counterparts on Data Management processes and standards.Support Regulatory Submissions and Regulatory Audits from a Data Management perspective.Oversight for Data Management vendor include - CRF review, database and dataset structure, Data Management Plan, Data Review Guidelines and edit specifications; Assure dictionary versions are correct; Request specific project tracking reports; Qualify vendor personnel; Review queries; Oversee change order activities; Perform internal activities associated with database lock at vendor (e.g. SAE reconciliation, dictionary term reconciliation, external vendor’s data reconciliation and document collection).Interface closely with other project teams and provide insights for protocols, statistical analysis plans, monitoring guidelines and Clinical Study Reports.Collaborate closely with Medical Monitor staff to review CRF coding for logic, consistency and medical appropriateness.Assure all gathered clinical data is complete and accurate to be included into reports and regulatory submissions.Work closely with vendors to ensure timelines are met for KPI reporting.Responsible for TLF creation for data quality review and risk-based monitoring.Required Qualifications:Master’s Degree preferred (Technology, Engineering, or Mathematics preferred)6+ years of relevant clinical Data Management experience.Proficient in clinical trial focused systems and tools (EDC, BI tools).Demonstrated MS Office proficiency.If you meet the required qualifications and are interested in this role, please apply today.Clinical Resource Network DistinctionCRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.About CRNFounded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.Opportunity Awaits.