As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 15,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.
What will you do?
Supports and leads the clinical data review activities that contribute to delivery of an analyzable database.
Serves as lead clinical data coordinator for one or more projects.
• Reviews clinical and external data for subjects enrolled in clinical research protocols based on edit specifications / data validation programs to facilitate data review.
• Maintains data management study documentation as appropriate.
• Performs proficient reviews of study datasets prior to client transfer.
• Manages the data review and external data reconciliation process.
• Mentors and trains other team members in data management skills and processes for individual studies.
• Utilizes internal systems to optimize and communicate resourcing issues and needs.
• Ensures study and task metrics are tracked and communicated to the project team and functional management.
• May participate in sponsor and/or third-party audits.
What you need to have?
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities.