Clinical Data Systems Lead (Onsite or Remote)

Posted 14 days agoViewed

💎 Seniority level: Lead, 4+ years

📍 Location: United States

🔍 Industry: Pharmaceutical

⏳ Experience: 4+ years

🪄 Skills: Project ManagementSQLSAS EGCommunication SkillsAnalytical SkillsStakeholder managementTechnical supportData modelingData management

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