Senior Clinical Research Associate / Associate Clinical Trial Manager

GondolaBio

. Support day-to-day management of clinical studies from start-up through enrollment, conduct, database lock, and closeout .

Posted 11/6/2026full-timeRemote • United StatesSenior💰 $110,000 - $120,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical studies from start-up to closeout, with a strong focus on regulatory compliance, project coordination, and effective communication across cross-functional teams. Proficient in utilizing clinical trial management systems and ensuring sponsor oversight of CROs and clinical sites.

Highest-signal resume keywords

Clinical Research ExperienceICH-GCP KnowledgeEDC, CTMS, eTMF, IRT, eCOA FamiliarityProject Coordination SkillsSponsor Oversight

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementStudy Timeline DevelopmentRisk Identification and MitigationData Review and CleaningRegulatory Submissions

Soft Skills

Strong Communication SkillsDetail-OrientedProactive Problem SolvingOrganizational SkillsAbility to Work Independently

Tools & Technologies

EDC SystemsCTMSETMFIRTECOA

Industry Keywords

Clinical TrialsBiotechnologyPharmaceuticalCRO EnvironmentSite Monitoring

About the role

Key responsibilities & impact

Support day-to-day management of clinical studies from start-up through enrollment, conduct, database lock, and closeout
Manage assigned studies or defined operational components under Clinical Trial Manager or Clinical Operations Lead direction
Develop, maintain, and track study timelines, milestones, risks, issues, and action items
Coordinate activities across internal functions, CROs, vendors, and clinical sites
Identify operational risks and support mitigation and escalation plans
Prepare study team meetings, status updates, and operational metrics
Serve as operational point of contact for assigned CROs, vendors, and clinical sites
Provide sponsor oversight of CROs, vendors, clinical sites, and monitoring activities
Participate in CRO and vendor selection, proposal review, RFP evaluation, and bid-defense activities
Monitor CRO/vendor performance, study metrics, risks, issues, deliverables, budgets, invoices, forecasts, and financial tracking
Support site feasibility, activation, monitoring follow-up, issue resolution, and sponsor oversight visits
Coordinate 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 review, data cleaning, and quality metrics
Support EDC, IRT, CTMS, eTMF, and eCOA systems and review study/site metrics
Support regulatory and IRB/IEC submissions and compliance with protocol, ICH-GCP, regulations, and company procedures
Maintain sponsor oversight of the Trial Master File and support audits, protocol deviation follow-up, compliance activities, and CAPAs

Requirements

What you’ll need

Bachelor's degree in life sciences, nursing, pharmacy, or a related field, or equivalent relevant experience
4+ years of clinical research experience in a biotechnology, pharmaceutical, or CRO environment, including CRA and site monitoring experience
Experience supporting clinical trials across study start-up, conduct, and closeout; sponsor-side experience preferred
Working knowledge of ICH-GCP, applicable clinical research regulations, and the clinical trial process
Experience working with clinical sites, CROs, and study vendors
Familiarity with EDC, CTMS, eTMF, IRT, and eCOA
Good organizational and project coordination skills with ability to manage multiple priorities
Strong written and verbal communication skills and ability to work effectively with cross-functional and remote teams
Detail-oriented, proactive, and able to identify and escalate study issues appropriately
Must be based in the United States
Ability to work independently in a remote environment across multiple time zones
Ability to travel approximately 10–20%

Benefits

Comp & perks

Patient Days
Learning and development resources
Robust and market-competitive compensation & benefits package (health, welfare & retirement programs)
Flexible PTO
Rapid career advancement for strong performers
Potential ability to work on multiple GondolaBio programs across multiple therapeutic areas over time
Partnerships with leading institutions
Decentralized model with decision-making power close to the science
Collaborative, fast-paced, data-driven environment