Senior Clinical Research Associate / Associate Clinical Trial Manager

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, conduct, and closeout; sponsor-side experience is preferred.

• Working knowledge of ICH-GCP, applicable clinical research regulations, and the clinical trial process.

• Experience working with clinical sites, CROs, and external study vendors.

• Familiarity with common clinical trial systems, including EDC, CTMS, eTMF, IRT, and eCOA.

• Strong organizational and project coordination skills, with the ability to manage multiple priorities and study deliverables.

• Excellent written and verbal communication skills and the ability to collaborate effectively with cross-functional and geographically distributed teams.

• Detail-oriented and proactive approach, with the ability to identify, assess, and escalate study issues appropriately.

• Ability to work independently in a remote environment and maintain effective communication with study teams, CROs, vendors, investigators, and clinical sites across multiple time zones.

• Availability to participate regularly in virtual study-team, CRO/vendor, and site meetings.

• Willingness to travel approximately 10–20% for sponsor oversight visits, investigator meetings, critical site visits, internal meetings, and other study-related activities.

Professional qualities:

• Patient-focused approach and commitment to high ethical standards.

• Ownership mindset, practical problem-solving ability, and sound judgment.

• Intellectual curiosity, attention to detail, and a commitment to excellence.

• Ability to work collaboratively and deliver against goals and milestones with quality, precision, and efficiency.

Benefits:

• Annual base salary of $110,000–$120,000. Actual compensation depends on relevant experience, skills, qualifications, and location.

• Market-competitive compensation and benefits package, including health, welfare, and retirement programs.

• Flexible paid time off.

• Patient Days offering opportunities to hear directly from individuals living with the conditions being addressed through clinical programs.

• Learning and development resources to support professional growth.

• Opportunities for career advancement based on performance.

• Potential to contribute to multiple programs across different therapeutic areas over time.

• Opportunities to collaborate with leading institutions.

• Decentralized team structure designed to support ownership, autonomy, and efficient decision-making.

• Collaborative, fast-paced, and data-driven working environment.

• Commitment to diversity, equity, and inclusion.

• Remote work arrangement within the United States.