Apply📍 United States
🔍 Pharmaceutical
- Bachelor’s degree in business, management information systems, computer science, life sciences, engineering or equivalent. Master’s preferred.
- 4+ years of pharmaceutical, clinical research, data management, health care technology experience or 6+ years of broader technology experience.
- Familiar with clinical trial process and clinical technology.
- Demonstrated knowledge of SAS and/or SQL programming skills and knowledge of database concepts.
- Familiar with CDASH and SDTM Standards.
- Demonstrated leadership traits and ability to influence without authority.
- Demonstrated effective communication skills.
- Demonstrated effective problem-solving and analytical skills.
- Develop a deep understanding of the capabilities and data flow for clinical technologies
- Support the delivery of clinical technologies for a given program or therapeutic area
- Track and analyze system timelines and metrics to ensure adherence to project plans, identify and mitigate potential risks and assess performance
- Develop actionable reports and presentations for stakeholders and senior leadership to inform decision-making and project adjustments
- Collaborate with internal and external stakeholders, including system leads, data management team, clinical teams and vendors
- Contribute the strategic development of clinical technology initiatives and lead the implementation as the tech project manager
- Maintain technical knowledge of the clinical data systems (EDC, IRT, eCOA, CDR and Imaging) and understand how the capability contributes to the submission data flow and overall DSS technology strategy
- Mentor Clinical Data Strategy and Operations Associates
- Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards
- Act as the clinical data systems SME during regulatory inspections and internal quality audits
Project ManagementSQLSAS EGCommunication SkillsAnalytical SkillsStakeholder managementTechnical supportData modelingData management
Posted 12 days ago
Apply