Note: The job is a remote job and is open to candidates in USA. Signant Health is a global leader in clinical trial technology, seeking a Project Manager to drive successful execution of clinical trial implementations. The role involves managing the full project lifecycle while ensuring compliance, data quality, and exceptional customer outcomes.
Responsibilities
- Own the full project lifecycle for clinical trial implementations and ongoing project management, from initiation through closeout, ensuring scope, timeline, budget, and quality objectives are met or exceeded
- Serve as the primary point of contact for sponsor and client stakeholders, proactively communicating project status, risks, and decisions while building trust and demonstrating deep understanding of their trial requirements and regulatory obligations
- Develop detailed project plans aligned with clinical trial protocols and regulatory requirements (ICH E6(R3), FDA, EMA), establishing clear milestones, dependencies, and risk mitigation strategies
- Coordinate with internal teams across Product, Support, Engineering, Sales, Quality, Regulatory Affairs, and IT to resolve project issues, escalate blockers, and drive timely decision-making
- Partner with Quality and Regulatory Affairs to ensure compliance with GxP frameworks and client audit requirements, proactively identifying and escalating compliance risks
- Demonstrate deep understanding of eClinical system data integrity and audit trail requirements—RTSM, eCOA, eConsent, EDC, and wearable integrations—and their impact on project execution and client confidence
- Lead or support inspection readiness activities, mock audits, and quality documentation reviews in preparation for sponsor, client audits, and regulatory inspections
- Manage project documentation, audit trails, and regulatory compliance artifacts with precision, ensuring systems and records meet data integrity expectations (21 CFR Part 11, EU Annex 11, GAMP 5)
- Synthesize project data and lessons learned into actionable insights for executive reporting, Quality Management Reviews, and continuous improvement initiatives
Skills
- 3–5 years of project management experience in clinical research, medical device, or healthcare technology, with at least 7+ years total experience in GxP-regulated environments
- Strong working knowledge of global GxP frameworks applicable to clinical trial technology: ICH E6(R3), 21 CFR Parts 11 and 820, EU Annex 11, GAMP 5, and data integrity principles (ALCOA+)
- Demonstrated experience managing clinical trial projects from setup through closeout, including regulatory submissions, compliance documentation, and audit/inspection readiness
- Direct hands-on experience with eClinical technology systems such as RTSM, eCOA, eConsent, EDC, and wearables, with deep understanding of their configuration, validation, and data integrity audit trail requirements
- Excellent written and verbal communication skills — ability to author project status reports, regulatory compliance documentation, inspection readiness briefs, and executive summaries with clarity and precision
- Proven ability to influence cross-functionally without direct authority, building collaboration across Product, Engineering, Quality, Regulatory, and Commercial teams to drive project success
- Ability to operate with authority and composure in high-stakes environments — sponsor audits, regulatory pressures, multi-site complexity — synthesizing project data into clear risk narratives for executive audiences
- Strong organizational problem-solver who can manage multiple concurrent projects while maintaining meticulous attention to detail and regulatory compliance
- Must be based in CST or EST time zone
- Project Management Professional (PMP) or Certified Associate Project Manager (CAPM) certification
- Certified Quality Auditor (CQA) or equivalent quality/audit certification
- Experience in a SaaS clinical technology organization with exposure to Computer Systems Validation (CSV) and release management
- Familiarity with wearable device integration, FDA-cleared digital biomarker products, and their regulatory context
- Experience with decentralized clinical trial (DCT) or remote patient monitoring platforms
Company Overview
Company H1B Sponsorship