Education Minimum Requirement:
B.A. or B.S. degree, preferably in life sciences, computer science or related field
Required Experience and Skills:
- 8+ years’ work experience which includes 4 years of data management experience and a minimum of 2 years clinical data standards development; or advanced degree with 6+ years’ work experience of which 2 years need to be in clinical data standards development
- A broad comprehensive knowledge of the clinical trial process including data management (data collection, processing, storage, and retrieval) and worldwide regulatory data management and reporting requirements.
- Advanced knowledge and leading-edge skills in clinical data standards (e.g., CDISC)
- CDISC Study Data Tabulation Model (SDTM) expertise
- Electronic Data Capture expertise (e.g. InForm)
- Analysis and Reporting experience
- Ability to effectively organize and manage multiple assignments with challenging timelines.
- Experience in defining, implementing, and managing process improvement projects and documentation
- Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines
- Exceptional communication skills (oral and written), with the ability to communicate with both the technical and business areas
- Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects.
Preferred Experience and Skills:
- Extensive program and/or project management experience managing and governing clinical information standards activities
- Exceptional people and thought leadership skills, with the ability to think strategically and to influence others.
- In-depth knowledge of and direct experience implementing industry standards (e.g. Controlled Terminologies, CDISC CDASH, SDTM, ADaM, & HL7) and requirements for submission deliverables (e.g., SDRG, ADRG, Define.xml)
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.