Associate Director - Clinical Data Management

Associate Director – Clinical Data Management

Bachelor’s degree in science, Technology, Engineering, or Mathematics, and/or equivalent knowledge and experience
Minimum 10 years’ Clinical DM experience
Minimum 5 years’ pharmaceutical company experience
Minimum 2 years’ people management experience
Multi Regional Clinical Trial experiences
Strong understanding of regulatory guidelines (and the related issues) (e.g. ICH/GCP) and the connection to DM deliverables (e.g. data quality and data integrity)
Strong understanding of Risk Based Quality Management
Good understanding of Medical coding (MedDRA and WHO Drug dictionaries) to check consistency codes and upgrade
Strong familiarity with CDISC (CDASH/SDTM)
Good understanding of Computerized System Validation
Proficient in systems and tools used in clinical trials (EDC, BI tools)
Proficient in Microsoft tools (Excel, Word, PowerPoint, etc.)
Basic knowledge of Decentralized Clinical Trials(DCT) and AI(Artificial Intelligence)

Managing and overseeing all aspects of data management (DM) for assigned projects
Managing staff and selecting and overseeing DM vendors
Supervising tasks performed by vendors and assuring data quality
Interfacing with in-house staff in establishing and maintaining global data standards and department procedures
Conducting risk assessments related to data and designing data quality by mitigating risks
Overseeing all aspects of data management tasks performed by vendor
Collaborating with an external vendor to create a Data Transfer Agreement
Assuring all clinical data is properly collected, cleaned and formatted
Working closely with DM vendors to ensure timelines are met
Responsible for budget planning for DM-related tasks
Supervising DM staff and managing DM resources
Participating as a subject matter expert in Regulatory Submissions and Regulatory Audits
Meeting and discussing with Japanese HQ regarding global Data Management procedures