Role overview
Lead a team responsible for keeping clinical research data accurate, complete, and timely across multiple sites. You’ll translate study and sponsor expectations into workable processes, guide day-to-day priorities, and partner with site and study teams to resolve data issues and strengthen quality.
Responsibilities
- Set expectations, assign work, coach Data Coordinators, and build team skills through feedback and training.
- Plan capacity and priorities across studies and sites, accounting for visits, sponsor timelines, monitoring, and database milestones.
- Oversee source review, EDC/CRF transcription, reconciliation, and documentation quality in line with protocols, GCP, sponsor requirements, and procedures.
- Track aging and high-risk queries, remove resolution barriers, and coordinate escalations with site teams, investigators, sponsors, CROs, and internal partners.
- Monitor quality, timeliness, workload, and recurring issues; report trends and lead practical process improvements.
- Support new study and tool rollouts, and contribute to audit and inspection readiness.
Requirements
- At least five years in clinical research, clinical data management, site coordination, or a related field, including two or more years leading, coaching, or coordinating others.
- Strong understanding of clinical research data workflows, including source documentation, EDC/CRF entry, reconciliation, and query management.
- Working knowledge of GCP, protocol compliance, sponsor expectations, and quality management.
- Experience handling confidential or regulated information with careful documentation and accuracy.
- Ability to lead a remote team, manage competing priorities, analyze trends, and communicate clearly with varied stakeholders.
- High school diploma or GED; a related bachelor’s degree is preferred.
Nice to have
- Experience with multi-site operations, sponsor-facing data work, EDC platforms, case report forms, and clinical source documentation.
- Familiaritywithqualitymanagementsystemsandelectronicdatatools.
Benefits and work setup
- Remote within the UnitedStates, with occasional planned travelunder10%.
- Listed annual pay range: $75,000–$95,000 for full‑time team members.
- Benefits for US full-time employees include paid time off and holidays, employer-paid medical, dental, and vision options, HSA and FSA plans, disability coverage, and a 401(k) with company match.