This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Clinical Research Associate / Associate Clinical Trial Manager based in the United States.
The Senior Clinical Research Associate / Associate Clinical Trial Manager will support the planning, execution, oversight, and delivery of clinical trials from study start-up through closeout. This sponsor-side role combines hands-on clinical monitoring and site management with growing responsibility for study-level operational leadership. You will coordinate activities across internal teams, CROs, vendors, investigators, and clinical sites to keep trials on schedule and aligned with quality and regulatory expectations. Working across multiple therapeutic programs and functions, you will help identify operational risks, maintain study readiness, and support high-quality clinical data and documentation. This is an opportunity to contribute directly to the development of innovative treatments for patients with genetic diseases in a collaborative, patient-focused, and fast-paced environment.
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Accountabilities:
Study management: Support day-to-day clinical study activities from start-up and enrollment through study conduct, database lock, and closeout. Manage assigned studies or defined operational components under the guidance of a Clinical Trial Manager or Clinical Operations Lead.
Study planning and coordination: Develop, maintain, and track study timelines, milestones, risks, issues, and action items. Coordinate internal functions, CROs, vendors, and clinical sites to ensure timely delivery of study activities and escalate operational risks with appropriate mitigation recommendations.
CRO and vendor oversight: Provide sponsor oversight of CROs and external vendors. Participate in vendor selection, proposal reviews, RFP evaluations, and bid-defense activities. Monitor performance against timelines, quality expectations, contracts, and deliverables, and support the resolution of issues.
Financial and operational tracking: Assist with vendor budgets, change orders, invoices, forecasts, and financial tracking. Prepare and contribute to study team meetings, status updates, and operational metrics.
Site management and monitoring: Support site feasibility, activation, monitoring follow-up, and resolution of site issues. Review monitoring reports, track findings and protocol deviations, and participate in remote or on-site sponsor oversight activities as needed.
Clinical supplies and sample logistics: Collaborate with Clinical Supply/CMC teams, CROs, vendors, central laboratories, and sites to support investigational product distribution and accountability, study supplies, biological sample logistics, and tracking of laboratory samples and study-specific endpoints.
Study documentation: Contribute to the development, review, and maintenance of clinical study documents, plans, tools, site-facing materials, and operational workflows.
Clinical data and systems: Work with Data Management to support timely, high-quality clinical data, including CRF review, data review, data cleaning, and study-specific quality metrics. Support the use of EDC, IRT, CTMS, eTMF, and eCOA systems and review metrics to identify operational issues and trends.
Regulatory, quality, and TMF oversight: Support regulatory and IRB/IEC submissions and help ensure compliance with protocols, ICH-GCP, applicable regulations, and internal procedures. Maintain Trial Master File (TMF) completeness, perform quality checks, support inspection readiness, and assist with audits, deviation follow-up, and CAPAs.
Requirements:
Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field, or equivalent relevant experience.
At least 4 years of clinical research experience in a biotechnology, pharmaceutical, or CRO environment, including CRA and clinical site monitoring experience.
Experience supporting clinical trials through study start-up,…