Manager, Clinical Data Standards (hybrid)

Title Manager, Clinical Data Standards Location Basking Ridge, NJ 07920 (Hybrid) Duration Contract until Nov 2026 (Possible extension) 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 DS Therapeutic areas. This position provides expertise within Data Management by partnering with diverse cross functional stakeholders to optimize data collection services for Daiichi Sankyo 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. Responsibilities Demonstrated ability to self-start, be solution-oriented with an innovative spirit, and be accountable for results by working in a fast-paced environment is essential. 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 essential. The Manager, Clinical Data Standards should be a subject matter expert in clinical data standards as it relates to developing clinical data collection tools. Qualifications CRO/pharma working background Minimum 5 years of experience Working hands‑on knowledge of the RAVE system, library build and management, development of edit checks in RAVE and SDTM knowledge 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 #J-18808-Ljbffr