Principal Data Scientist (Clinical Data Management) - Remote

Data Management United States


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Principal Data Scientist to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

At Premier Research, we are science-minded and heart-centered. Join us.

As a Principal Data Scientist with Premier Research, your primary responsibility is to independently serve as a member of the project or program oversight team, taking on the role of Lead Data Scientist. You ensure quality data collection, receipt, processing, and review within study scope and in alignment with department operating procedures. This includes creation, management, execution and storage of data plans, specifications, guidelines, listings, and reports. Mentors and develops junior staff. You will participate in business development activities, including capabilities and proposal defense meetings, and cost estimates for new opportunities.

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.

  • Creates, maintains, executes and stores data and related documentation as outlined in department operation procedures and as required by study.

  • Responsible for functional area eTMF filing and quality control activities or equivalent as per study. Participates in internally and externally managed study audits as required.

  • 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 the generation, review and reporting of study metrics and financials.

  • 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.

  • Coaches, supports and mentors less experienced data coordinator or scientist staff, including new hires

  • Participates in new project cost estimates, proposal review, proposal defense and capabilities presentations with minimal oversight

You’ll need this to be considered:

  • 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 7 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

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