Project Manager

About Signant Health & Ametris

Signant Health is a global leader in clinical trial technology, trusted by the world's leading CROs and biopharmaceutical companies to deliver smarter, more connected research. As the parent company of Ametris — a pioneer in digital health with over 20 years of expertise in clinical research — Signant combines advanced wearable sensor technology, expert scientific consultation, and regulatory-aligned analytics to support every phase of a trial, from study design through regulatory submission. At the intersection of artificial intelligence and clinical innovation, Signant Health is actively integrating AI-driven capabilities across its platform to accelerate trial design, enhance data quality, and unlock deeper insights from complex clinical datasets.

Ametris is the thought and market share leader in wearable-based solutions supporting academic research and biopharmaceutical clinical trials. Its FDA-cleared wearable monitors and robust analytics platform have been widely adopted to quantify human movement in academic and population health research for nearly two decades — and are now the most widely used research-grade activity monitoring system in the world, with clients at more than 1,500 university and scientific institutions across 100+ countries.

About the Role

Ametris – a Signant Health Company is seeking a Project Manager who can drive the successful execution of clinical trial implementations while ensuring rigorous compliance, superior data quality, and exceptional customer outcomes. This operational leader will translate Ametris' scientific expertise and innovative wearable technology into seamless project delivery that strengthens our position as the trusted partner for digital biomarkers and clinical research.

Reporting to the Director of Project Operations, the Project Manager will own end-to-end project delivery for clinical trial implementations and ongoing project management, ensuring alignment across cross-functional teams while maintaining the highest standards of regulatory compliance and quality. This role offers the opportunity to partner with leading pharmaceutical companies, CROs, and research institutions while advancing the adoption of wearable-based clinical solutions globally.

What You Will Own

• 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.

What We're Looking For

• 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

Nice to Have

• 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.

Why Join Signant Health & Ametris

Joining Signant Health and Ametris means stepping into a company where your work directly shapes the future of clinical research. You'll be part of a global team that partners with the world's most innovative CROs, biopharmaceutical companies, and research institutions — not to support the status quo, but to challenge it. With Ametris wearable sensor technology and Signant's AI-driven clinical platform, you'll have industry-leading tools behind you and the opportunity to advance how clinical trials are executed globally. This is a company that invests in people who think critically, move with purpose, and are energized by regulatory complexity and clinical science. If you are passionate about the intersection of science, technology, and human health — and want to translate that into operational excellence at a global scale — Signant Health and Ametris offer a rare opportunity to make a lasting impact.

At Signant Health, accepting difference isn't enough — we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients, and our community. We are proud to be an equal opportunity workplace and an affirmative action employer, committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or veteran status. Prior to their start date, all candidates are required to be verified through a thorough background check and identity verification to confirm eligibility for employment.