Senior Clinical Research Associate / Associate Clinical Trial Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the daily management of clinical studies from start-up through enrollment, execution, database locking, and closeout.

• Oversee assigned studies or specific operational components under the guidance of the Clinical Trial Manager or Clinical Operations Lead.

• Create, maintain, and track study timelines, milestones, risks, issues, and action items.

• Facilitate activities across internal teams, CROs, vendors, and clinical sites.

• Recognize operational risks and assist in developing mitigation and escalation strategies.

• Organize study team meetings, status reports, and operational metrics.

• Act as the operational liaison for assigned CROs, vendors, and clinical sites.

• Provide oversight for sponsors regarding CROs, vendors, clinical sites, and monitoring activities.

• Engage in the selection of CROs and vendors, proposal assessments, RFP evaluations, and bid-defense efforts.

• Track CRO/vendor performance, study metrics, risks, issues, deliverables, budgets, invoices, forecasts, and financial monitoring.

• Assist with site feasibility, activation, monitoring follow-up, issue resolution, and sponsor oversight visits.

• Manage investigational product distribution, study supplies, biological sample logistics, and laboratory sample tracking.

• Develop, review, and maintain clinical study documents, plans, tools, workflows, and site-facing materials.

• Collaborate with Data Management on CRF review, data assessment, data cleaning, and quality metrics.

• Support EDC, IRT, CTMS, eTMF, and eCOA systems and review study/site metrics.

• Assist with regulatory and IRB/IEC submissions and ensure compliance with protocols, ICH-GCP, regulations, and company procedures.

• Maintain sponsor oversight of the Trial Master File and assist with audits, protocol deviation follow-ups, compliance activities, and CAPAs.

⛳️ Requirements

• Bachelor's degree in life sciences, nursing, pharmacy, or a related field, or equivalent relevant experience.

• Minimum of 4 years of clinical research experience in a biotechnology, pharmaceutical, or CRO setting, including CRA and site monitoring experience.

• Experience in supporting clinical trials throughout study start-up, execution, and closeout; sponsor-side experience is preferred.

• Proficient understanding of ICH-GCP, relevant clinical research regulations, and the clinical trial process.

• Experience collaborating with clinical sites, CROs, and study vendors.

• Familiarity with EDC, CTMS, eTMF, IRT, and eCOA systems.

• Strong organizational and project coordination abilities with the capability to manage multiple priorities.

• Excellent written and verbal communication skills, with the ability to work effectively with cross-functional and remote teams.

• Detail-oriented, proactive, and capable of appropriately identifying and escalating study issues.

• Must be located in the United States.

• Ability to work independently in a remote setting across various time zones.

• Willingness to travel approximately 10–20%.

🏝️ Benefits

• Patient Days.

• Access to learning and development resources.

• Comprehensive and competitive compensation & benefits package (health, welfare & retirement programs).

• Flexible PTO.

• Opportunities for rapid career advancement for high achievers.

• Potential to work on multiple GondolaBio programs across various therapeutic areas over time.

• Collaborations with leading institutions.

• Decentralized structure with decision-making authority close to the science.

• Fast-paced, collaborative, and data-driven work environment.