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Principal Data Scientist
hace 2 semanas
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 (Lead Data Manager)** 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**:
- 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 mínimal oversight
**What We Are Searching For**:
- Bachelor’s Degree preferably in Life Science required and Post Graduate preferred
- Previous experience in Data Management or relevant industry experience, with at least 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
**Why Choose Premier Research?**
- 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.
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