Clinical Study Data Manager
- Experience Level
At PRA, we know that our people are our greatest strength, so we work hard to hire the very best.
If you join our team, you can expected to be challenged, rewarded and nurtured.
We have a dynamic and loyal workforce, a culture that values individuality and innovation and an ongoing commitment to employee growth and development.
The result? A dynamic and loyal workforce who take pride in the their work on clinical development which changes lives.
PRA are looking to expand our European Clinical Data Management team; the Clinical Data Scientist Lead is responsible for end-to-end data review activities performed on a clinical trial and for achieving clinical data management deliverables on-time, with high quality and to agreed financial metrics.
Main responsibilities include:
• Serving as the primary contact for internal and external team members regarding clinical data management data review activities
and leads these review activities to ensure the delivery of data fit for analysis.
• Providing input into clinical system development activities, to ensure systems support the data review needs of the study, focusing
on critical data and processes, and identified risks.
• Ensuring clinical data management review requirements are put into production per the study’s protocol risk evaluation and
integrated data review plan (IDRP), and that ongoing data review activities are compliant with study plan requirements.
Contributing to the development and maintenance of study plans documents specifying data review strategy and applicable
procedures on assigned protocols/projects, including but not limited to data management plan.
• Centrally reviewing clinical data at aggregate level, using analytic reporting tool(s) to support the identification of risks and data
patterns/trends. Mitigates risks by using signal detection and quality indicators.
• Proactively identifiying out-of-scope clinical data management activities to the study project managers to be implemented in required
• Leading and hosting the data monitoring meetings, communicating issues to the internal and external stakeholders in a meaningful
way such as summarizing the data and representing the information visually.
This role is home-based and can be located anywhere in Europe.
Technically capable, a strong communicator, highly organized and possess first class project management skills! The ideal applicant will have an understanding of data science, analytics or management, with an understanding of biometrics, mobile health platforms, machine learning, risk indicators or risk control.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- Bachelors Degree or higher/equivalent in a Scientific or Healthcare related field
- Strong Clinical Data Management experience at oversight level
- Data Science and Central Monitoring knowledge highly advantageous
- Knowledge of EDC systems e.g. Medidata Rave
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.