Note: The job is a remote job and is open to candidates in USA. GSD Health Research is a clinical research strategy and delivery organization focused on participant-centered studies, digital health, and women's health. The Clinical Research Operations Manager will lead defined workstreams across digital, hybrid, direct-to-participant, and FDA-regulated studies, coordinating study delivery, participant-facing platform operations, quality control, change management, and communications with sponsors, sites, and technology partners.
Responsibilities
- Own defined clinical operations workstreams and track key milestones, risks, decisions, and deliverables across active studies
- Translate protocols and sponsor decisions into practical workflows, timelines, operating plans, and accurate study documentation
- Support feasibility, resourcing, and launch planning, coordinating follow-up across GSD and external collaborators
- Configure, review, or coordinate surveys, digital patient-reported outcomes, notifications, schedules, and participant communications within participant-facing research platforms
- Evaluate the full participant journey and identify unclear language, avoidable burden, accessibility concerns, workflow gaps, and points requiring additional support
- Monitor enrollment and study activity; triage participant and site questions; and identify issues involving data flow, scheduling, devices, incentives, or study procedures
- Develop, execute, and document user-acceptance and quality-control testing for participant journeys, surveys, notifications, schedules, and other study workflows
- Maintain clear issue and change-control logs; assess operational and regulatory implications; and ensure approved changes are tested, documented, and communicated
- Use study metrics, participant or site feedback, and recurring support issues to identify practical improvements to study design and execution, and fold those lessons into the SOPs, playbooks, templates, and training materials that strengthen consistency and audit readiness as GSD grows
- Prepare concise status updates, meeting notes, decision summaries, and recommendations for GSD leadership and external partners
- Communicate clearly with sponsors, research sites, technology teams, and other collaborators, including when an issue requires clarification, escalation, or a decision
- Synthesize operational lessons, research findings, or emerging practices for internal discussions, presentations, reports, or scientific communications
Skills
- A bachelor's degree in public health, life sciences, health sciences, clinical research, or a related field, or equivalent relevant experience
- At least four years of hands-on experience in prospective clinical research or clinical trial operations, with meaningful responsibility across multiple studies. The depth and relevance of experience matter more than a precise number of years
- Working knowledge of Good Clinical Practice, IRB requirements, research documentation, participant privacy, and the operational expectations of sponsor-facing research
- Demonstrated ability to manage a defined workstream independently, anticipate next steps, make sound operational judgments, and escalate appropriately
- Experience serving as a day-to-day operational point of contact for sponsors, research partners, sites, or technology vendors, with the judgment to resolve routine issues independently and escalate appropriately
- Strong organizational skills and the ability to maintain accuracy while managing multiple timelines, dependencies, and stakeholders
- Clear, credible written and verbal communication with research participants, investigators, sponsors, sites, and technical partners
- Comfort working in a small, collaborative environment where priorities can evolve as studies move from design through launch and active execution
- A genuine interest in participant-first research, digital health, and improving the evidence base for women's health
- Experience with digital, decentralized, direct-to-participant, or hybrid clinical studies
- Experience configuring or operating participant-facing research platforms, including eConsent, ePROs, surveys, schedules, notifications, or participant communications
- Experience incorporating wearable devices, sensors, connected medical devices, electronic health records, digital measures, or remote biosample collection into research
- Experience supporting participant recruitment, remote follow-up, site coordination, active study operations, or participant support
- Experience developing test plans, conducting user-acceptance testing, managing change control, or improving clinical research workflows
- Comfort working in technology-enabled research environments and troubleshooting unfamiliar digital workflows: for example, querying data exports or tracing how a configuration change ripples into downstream schedules or notifications. Coding is not required
- Academic, professional, volunteer, or personal interest in women's health research
Benefits
- Paid time off and paid company holidays, subject to company policy and applicable law.
- Employer-funded ICHRA allowance toward eligible individual health insurance costs, subject to plan terms and eligibility.
- Participation in GSD's 401(k) retirement plan, subject to plan eligibility.
- A remote work environment with flexibility, balanced with availability for scheduled meetings and meaningful overlap with U.S. business hours.
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