Clinical Project Manager (1160064)

The Judge Group; Rockville (MD); On-site; USD 135,000 - 160,000; Full time

Benefits offered by this job

401k

Dental

Vision

Bonus potential

Job summary

The Judge Group in Rockville, MD is seeking a Clinical Project Manager to own the day-to-day operations of oncology trials. You will build and track timelines, budgets, and enrollment plans, coordinate CROs and vendors, and keep sites, data, and documentation inspection-ready.

This full-time role requires a life science degree and 5+ years of clinical operations experience, including 2+ years leading trials.

Qualifications

• Bachelor's degree in life sciences, nursing, or related field.
• 5+ years of clinical operations experience, incl. 2+ years leading trials.
• Oncology trial experience.
• Hands-on CRO/vendor management including budgets & timelines.
• Strong ICH-GCP and FDA regulation knowledge.
• Proven project management skills with timelines and risk logs.
• Experience with eTMF, EDC, and CTMS systems.

Responsibilities

• Lead operational planning for oncology studies from startup to close-out.
• Build and maintain integrated study timelines, enrollment projections, and milestone plans.
• Manage study budgets, forecasts, and accruals with Finance, including CRO and site payments.
• Run cross-functional study team meetings and report status, risks, and decisions to leadership.
• Serve as primary sponsor contact for CROs and specialty vendors.
• Set and track KPIs, review deliverables, and resolve performance issues.
• Review and support scopes of work, change orders, and vendor contracts.
• Oversee site feasibility, activation, and performance across US and international sites.
• Drive enrollment and retention strategies; identify underperforming sites.
• Support investigator meetings and maintain relationships with academic oncology centers.
• Ensure studies run in compliance with ICH-GCP, FDA regulations, protocols, and SOPs.
• Oversee the Trial Master File for completeness and inspection readiness.
• Contribute to protocols, informed consent forms, monitoring plans, and study manuals.
• Partner with Data Management, Biostatistics, Drug Safety, and Regulatory on data quality and submissions.
• Support audits, inspections, deviations, and CAPAs.

Skills

Project management

Clinical operations

Oncology trials

Vendor management

ICH-GCP knowledge

FDA regulations knowledge

Education

Bachelor's degree in life sciences, nursing, or related field

Tools

eTMF

EDC

CTMS

Job description

Location: Rockville, MD

Salary: $135,000.00 USD Annually - $160,000.00 USD Annually

Description: Our client is currently seeking a Clinical Project Manager to own the day-to-day operational execution of its oncology clinical trials. This person runs studies as projects: building and tracking timelines, budgets, and enrollment plans; directing CROs and vendors; and keeping sites, data, and documentation on track and inspection ready. This is a full-time role in Rockville, MD with competitive salary + bonus + benefits like 401k, dental, vision, etc.

This Job Will Have The Following Responsibilities

Study planning and project management

• Lead operational planning for assigned oncology studies from startup through database lock and close-out.
• Build and maintain integrated study timelines, enrollment projections, and milestone plans.
• Manage study budgets, forecasts, and accruals with Finance, including CRO and site payments.
• Run cross-functional study team meetings and report status, risks, and decisions to leadership.

CRO and vendor oversight

• Serve as the primary sponsor contact for CROs and specialty vendors (central labs, IRT, imaging, biomarker labs).
• Set and track KPIs, review deliverables, and escape and resolve performance issues.
• Review and support scopes of work, change orders, and vendor contracts.

Site management and enrollment

• Oversee site feasibility, selection, activation, and ongoing site performance across US and international sites.
• Drive enrollment and retention strategies; identify and fix underperforming sites.
• Support investigator meetings and maintain strong relationships with key academic oncology centers.

Quality, compliance, and documentation

• Ensure studies run in compliance with ICH-GCP, FDA regulations, protocols, and SOPs.
• Oversee the Trial Master File for completeness and inspection readiness.
• Contribute to protocols, informed consent forms, monitoring plans, and study manuals.
• Partner with Data Management, Biostatistics, Drug Safety, and Regulatory on data quality, SAE reconciliation, and submissions.
• Support audits, inspections, deviations, and CAPAs.

Qualifications

Required

• Bachelor's degree in a life science, nursing, or related field.
• 5+ years of clinical operations experience, including 2+ years managing trials as a CTM or study lead.
• Oncology trial experience.
• Hands-on management of CROs and vendors, including budgets and timelines.
• Strong working knowledge of ICH-GCP and FDA regulations.
• Proven project management skills: timelines, risk logs, and clear status reporting.
• Experience with eTMF, EDC, and CTMS systems.