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 Distinction
CRN, 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 CRN
Founded 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.
