Senior Clinical Data Manager

About the role

eClinical Solutions is dedicated to accelerating clinical development initiatives through expert data services and the elluminate Clinical Data Cloud. The elluminate platform and digital data services offer clients self-service access to all their data and advanced analytics for informed decision-making.

Responsibilities

• Independently act as a study lead and oversee clinical trial database(s) through the full data management process life cycle.
• Create and oversee database design specifications, validation, maintenance/data cleaning, and closeout activities.
• Delegate tasks/responsibilities to multiple team members in multiple projects.
• Ensure efficient and consistent data management tasks across programs.
• Communicate with global study teams and participate in client study kickoff and closeout/lessons learned meetings.
• Create and present materials for Investigator Meetings and conduct Sponsor CRA and/or site training.
• Develop and maintain data management documents such as DMPs, eCRF Completion Guidelines, CRFs, and Help Text.
• Oversee and develop internal system testing plans and IST on the database/user roles/edit check specifications.
• Utilize centralized data management platforms including graphical patient profiles and operational analytics.
• Compile sponsor UAT packages and oversee data review, manual review/QC checks, and vendor data reconciliation.
• Provide ongoing data management reports and metrics, track data management issues, and assist with process improvements.
• Mentor junior level staff and peers on all associated tasks within a study.
• Participate in proposal defenses and perform other duties as requested by management.

Qualifications

• Bachelor’s degree in Pharmaceutical/Biotechnology or higher in health-related field preferred.
• 8+ years in Clinical Data Management experience preferred.
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology.
• Strong project management experience and project team leadership skills, including work planning and work delegation.
• Experience with EDC and performing data management activities.
• Excellent verbal and written communication skills.
• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel.
• Experience with EDC and Clinical Data Management Systems.