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United States
Remote only
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
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
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status