.Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Clinical Data Scientist/Data Manager who shares our vision of providing clinical research excellence.
Joining Pivotal as a Clinical Data Scientist/Data Manager, means that you will enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation.
This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company.
You'll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.
Why Pivotal: We are passionate and fully committed with medical science while using technology, to make a positive impact We provide an exceptional experience.
We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong Your responsibilities will include: You will oversee data management and clinical surveillance activities, including: Support the design and management of CRFsand the study database (DB), including design, setup, validation, data entry oversight and training.
Developing and maintaining the Data Management Plan, Data Quality Plan, and Edit check specifications.
Creating CRF guidelines, annotated CRFs, and managing data discrepancies.
Providing analytical support for clinical trial data, including analysis, interpretation, and preliminary recommendations.
Monitoring data review issues, ensuring timely query resolution, and performing QA/QC for the study database.
Managing database lock processes and applying a risk-based approach to assess trials and proactively address issues.
Communicating data review findings to internal and external stakeholders.
Supporting study committee activities (e.G., DMC).
Maintaining the DMBS file system.
Identifying, monitoring, and tracking potential study risks.
Assisting in the development of predictive models, machine learning algorithms, and visualization techniques to identify trends and propose solutions in collaboration with data architects, software engineers, and product development teams.
Performing other assigned duties as needed.
Required profile: Education : University degree highly recommended; Experience: 4 years in Data Management Systems at a CRO or pharmaceutical company.
Hands-on experience with CDM systems: Medidata Rave Zelta, Medrio, Oracle u others.
Familiarity with GCDMP, ICH and CDISC standards (specially CDASH) and applicable data privacy regulations.