Premier Research is looking for a Principal Data Scientist (Lead Data Manager) to join our Clinical Data Sciences team.
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 Built for You. 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.
We are Built by You. Your ideas influence the way we work, and your voice matters here.
We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for Biotech™. Join us and build your future here.
What you'll be doing:
- Lead Data Strategy & Execution: Drive clinical database development, including eCRF design, edit check implementation, UAT, and external data source integration. Contribute to data risk assessment and mitigation strategies throughout the study lifecycle.
- Collaborate & Communicate Effectively: Partner with internal and external project teams (including data vendors) to ensure seamless data collection, review, and reporting. Facilitate study team discussions, manage meeting agendas and documentation, and communicate effectively with data team members to ensure coordinated task execution and adherence to study timelines.
- Ensure Data Quality & Compliance: Create, maintain, and store study data and documentation according to SOPs, department guidelines, and regulatory requirements. Oversee eTMF filing and quality control activities, and participate in internal and external audits.
- Manage Budgets & Metrics: Oversee functional area study budgets, identify and communicate potential out-of-scope activities, and contribute to re-scoping efforts. Generate, review, and report on key study metrics and financials.
- Drive Process Improvement & Innovation: Execute all tasks in alignment with SOPs, department guidelines, and data standards. Contribute to the evaluation, development, and implementation of SOPs and process improvements, and potentially lead departmental initiatives.
- Mentor & Develop Team Members: Coach, support, and mentor less experienced data coordinator or scientist staff, including new hires. Participate in new project cost estimates, proposal review, proposal defense, and capabilities presentations.
What we are searching 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 7 years’ experience leading studies
- Experience working within several clinical data management systems and in-depth knowledge of at least 2, preferably Medidata Rave or Ennov DataLabs EDC
- Knowledge of data standards and data modeling
- Knowledge of statistical principles and analysis considerations
Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $133,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.
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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