Associate Principal Data Scientist (Data Manager)

What You’ll Be Doing

• Interacts with internal and external project team members (including external data vendors) for multiple projects, as appropriate.
• Actively contributes to study team discussions, standing meeting agendas, meeting attendance and review and/or documentation of minutes.
• Facilitates clinical database development to execute collection, receipt, reporting, review and archiving of quality clinical trial data.
• Includes eCRF planning discussions, coordination of eCRF review, planning and identification of system and protocol-specific edit checks, coordination and proper execution of User Acceptance Testing, and coordination, planning and development for external data sources as required.
• Participates in early study team planning of data risk assessment and continuous evaluation of risks throughout course of study.
• Offers insight and mitigates risks of data loss.
• Communicates with assigned data team members to ensure tasks are coordinated and executed as per study plans and timelines as appropriate.
• Ensures training of study-specific protocol requirements as appropriate.
• Identifies and communicates gaps in training and supports training of data reviewers.
• Responsible for oversight of study budget applicable to functional area.
• Identifies and communicates potential out of scope activities to project team.
• Works with study team to provide needed information for re-scoping when applicable.
• Responsible for execution of all tasks as aligned with SOPs, department guidelines and data standards.
• Reviews and contributes to evaluation, development and implementation of SOPs and department guidelines.
• May assist in leading departmental initiatives and process improvements when required with support.

What We Are Looking For

• Bachelor’s Degree preferably in Life Science required and Post Graduate preferred
• 8-12 years mastery in Data Management or relevant industry experience, with at least 5 years’ experience leading studies
• Experience working within several clinical data management systems and in-depth knowledge of at least two, preferably Medidata Rave or DataLabs EDC
• Knowledge of data standards and data modeling
• Knowledge of statistical principles and analysis considerations