What are the responsibilities and job description for the Manager, Clinical Data Standards (Hybrid) position at Aequor?
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 Daiichi Sankyo 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.
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
MINAKSHI SANGWAN
Recruiting Lead - US Recruitment
O 732-339-3518
E Minakshi.sangwan@aequor.com
W http://www.aequor.com/