Support planning, execution, and closeout of trials
Ensure trial activities are conducted in accordance with protocols, SOPs, and GCP
Assigned clinical trials are executed according to plan, timeline, and quality expectations
Study documentation and systems remain accurate and up to date
Identify and escalate potential impacts to timeline, cost, or quality
Support development of mitigation plans in partnership with study leadership
Communicate effectively with Clinical Operations, Data Management, Regulatory, CMC, and external partners
Support alignment across stakeholders on study priorities and expectations
Assist with vendor and site budgets, supporting invoice and budget activities
Assist with site management activities, including review of monitoring reports and tracking site visits
Maintain Trial Master File completeness and accuracy
Support compliance activities, quality issue identification, and resolution
Ensure timely updates to CTMS, clinical trial registries, and internal systems
Communicate study status, metrics, and emerging issues with clarity and urgency
Maintain trial inspection-readiness
Support development of study tools, templates, and training materials
Contribute to process improvements, SOPs, and departmental initiatives

Requirements

BA/BS degree in life sciences or related discipline
8+ years of experience in biotech or pharmaceutical clinical drug development
Hands‑on experience supporting Phase 1–3 clinical trials
Working knowledge of GCP, clinical trial systems, and regulatory requirements
Experience working with CROs, vendors, and investigative sites
Strong organizational skills with the ability to manage multiple priorities
Proficiency with Microsoft Office and clinical data systems (e.g., CTMS, eTMF)
Experience in rare disease, specialty indications, and/or gene or cell therapy preferred

Benefits

Blue Cross Blue Shield PPO Medical Plan
Company-funded Health Savings Account
Dental and Vision Insurance
Life and Disability Insurance
Dependent Care Account
Tuition Reimbursement
401(k) plan with company match
Employee Assistance Plan
Wellness Programs
Flexible Paid Time Off policy

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial managementGCPclinical data systemsPhase 1 clinical trialsPhase 2 clinical trialsPhase 3 clinical trialsSOPscompliance activitiesprocess improvementsbudget management

Soft Skills

organizational skillscommunicationstakeholder alignmentproblem-solvingtime managementcollaborationattention to detailadaptabilityleadershipclarity in communication