Oncology Principal Data Scientist (Clinical Data Management) - Remote
At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.
We’re looking for a Principal Data Scientist to join our Clinical Data Sciences team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.
What you’ll be doing:
- Interact with internal and external project team members (including external data vendors) for multiple projects, as appropriate. Actively contribute to study team discussions, standing meeting agendas, meeting attendance and review and/or documentation of minutes.
- Facilitate 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.
- Participate in early study team planning of data risk assessment and continuous evaluation of risks throughout course of study. Offer insight and mitigate risks of data loss.
- Communicate with assigned data team members to ensure tasks are coordinated and executed as per study plans and timelines as appropriate. Ensure training of study-specific protocol requirements as appropriate. Identify and communicate gaps in training and supports training of data reviewers.
- Responsible for oversight of study budget applicable to functional area. Identify and communicate potential out of scope activities to project team. Work with study team to provide needed information for re-scoping when applicable.
- Review and contribute 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 Searching For:
- Minimum of a Bachelor's Degree, preferably in Science, Engineering, or Math, or RN, RPh, or LPN certification preferred along with a minimum of 8 years of mastery in data management/science/analytics/informatics and at least 7 years leading studies
- Proven expertise in ICH/GCP and/or ISO14155 requirements; knowledge of site and institution specific contract requirements; clinical trials support or pharmaceutical industry experience; working knowledge of medical terminology and experience with clinical research; working knowledge of FDA Guidance Documents and clinical monitoring procedures; working knowledge of data standards and data modeling, statistical principles and analysis considerations.
- Understanding and experience at least one Database Management System (e.g., Medidata Rave, Calyx/DataLabs EDC, Oracle Inform, etc.), working knowledge of IVRS/IRT, CTMS, and other platforms relevant to the role.
- Known for being customer-focused in approach to work and communications with the ability to professionally Interact with site, clients, vendors and other functional areas; strong verbal and written communication and negotiation skills.
- Ability to cultivate and thrive in a positive, results-oriented work environment; collaborative; able to build and coordinate efforts of an effective project team.
- Excellent organizational and time-management skills, able to prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strongly committed.
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly.
Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.
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.