Clinical Data Standards Manager | Pharma | CDISC | SDTM | RAVE | CRO Experience

Job Title Manager, Clinical Data Standards Location Basking Ridge, NJ 07920 Duration Contract till Nov 2026 with possibility to extend Checklist This opening is to cover for someone on maternity leave We're looking for someone local and able to come onsite as needed (hybrid) RAVE system (library build and management, development of edit checks) SDTM clinical data standards Job Schedule Local and able to come onsite as needed - maximum of 2 hours commute round trip. Job Summary The Manager, Clinical Data Standards, is responsible for the development and sustainability of the Global Clinical Data Standards for quality submissions and success of the client R&D pipeline by managing activities associated with standards development, management, and implementations for client Therapeutic areas. This position provides expertise within Data Management by partnering with diverse cross functional stakeholders to optimize data collection services for client Programs. The position will also help in defining standards collection and mapping data definitions thereby ensuring alignment with industry (CDISC) standards for Health Authority regulations. Working knowledge of various data types, data collection methods (EDC & Non-EDC), and direct experience implementing industry standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, etc.) for data submissions and relative processes is a must. Demonstrated ability to self-start, be solution-oriented with an innovative spirit, and be accountable for results by working in a fast-paced environment are some of the requirements of this role. Leading-edge skills in clinical data standards, expertise in Study Data Tabulation Model (SDTM), excellent verbal/written skills, analytical, and interpersonal skills for working effectively with people at different levels are also some of the requirements of this role. The Manager, Clinical Data Standards should be a subject matter expert in clinical data standards as it relates to developing clinical data collection tools. Skills CRO/pharma working background Minimum 5 years of experience Working hands on knowledge of RAVE system, library build and management. Development of edit checks in RAVE SDTM knowledge and working experience Team player who can interact and operate with a cross functional team. Strong communication and presentation skills required. Education Bachelor's Degree or higher in life sciences or related field required #J-18808-Ljbffr Aequor