Clinical Trial Manager

Greetings from IT Engagements

IT Engagements is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. We have an immediate opening for the below position with one of our premium clients.

Job Summary

Job Title: Clinical Trial Manager

Work Location: Remote

Work Experience: 8 years

Position Summary

The Clinical Trial Manager (CTM) leads the day-to-day operational execution of Phase I IV clinical trials in strict compliance with FDA regulations, GCP, and ICH guidelines. This role acts as the central hub, cross-functionally coordinating internal teams, Contract Research Organizations (CROs), vendors, and clinical sites to keep studies on timeline, within budget, and inspection-ready.

Key Responsibilities

• Study Execution & Governance: Direct all operational aspects across study start-up, active conduct, and close-out. Develop core trial documents, including study protocols, Informed Consent Forms (ICFs), Clinical Monitoring Plans, and operational SOPs.

• Vendor & CRO Management: Lead the evaluation, RFP process, and performance oversight for CROs, central labs, eCOA/IRT providers, and site monitoring services. Track KPIs, review monitoring visit reports, and resolve operational bottlenecks.

• Site Management & Patient Recruitment: Oversee site feasibility assessments, selection, activation, and investigator meetings. Design patient enrollment and retention strategies to ensure recruitment targets are hit without compromising data quality.

• Financial & Resource Tracking: Manage multi-million-dollar study budgets, approve vendor invoices, track pass-through costs, and handle change orders.

• Regulatory & Quality Assurance: Ensure absolute compliance with FDA 21 CFR regulations, GCP, and local IRB requirements. Maintain Trial Master File (TMF) completeness and lead audit/inspection readiness efforts.

• Data Integrity & Cross-Functional Alignment: Partner with Data Management, Safety/Pharmacovigilance, Biostatistics, and Medical Writing to facilitate timely database locks and Clinical Study Reports (CSRs).

Required Qualifications & Education

• Education: Bachelor's degree in Life Sciences, Nursing, or related health discipline (Master's or PharmD preferred).

• Experience: 5+ years in clinical research operations, including at least 2 3 years of direct study management experience within a sponsor company or CRO.

• Regulatory Expertise: In-depth knowledge of FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), ICH-GCP guidelines, and ClinicalTrials.gov registry maintenance.

• Technical Skills: Proficiency with EDC (e.g., Medidata Rave), CTMS, eTMF systems, IRT/IxRS, and Microsoft Office / Project.

• Certifications (Preferred): SOCRA (CCRP) or ACRP (CP/CTM) certification.

Regards,
Satya
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