Senior Clinical Trial Manager

TalentCraft; Deerfield (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

TalentCraft is seeking an experienced clinical operations professional to oversee the practical delivery of active studies and coordinate with CROs and sites across trials. This onsite role requires frequent site visits, collaboration with investigators, and proactive risk mitigation to keep timelines and budgets on track.

The ideal candidate has 5+ years in clinical research, hands-on trial management experience, and strong knowledge of CTMS, eTMF, and EDC.

Qualifications

• Bachelor's degree in life sciences, nursing, healthcare, or a comparable field.
• At least five years in clinical research with ownership of trial management activities.
• Experience directing CROs or external vendors with sponsor oversight.
• Exposure to site activation, trial conduct, amendments, and closeout.
• Experience visiting research sites and collaborating with investigators and coordinators.
• Understanding of site workflows, participant logistics, and nursing background beneficial.
• Ability to manage schedules, costs, and risks while driving problem resolution.
• Working knowledge of GCP and platforms CTMS, eTMF, EDC.
• Strong communication and project coordination skills.
• Experience in obesity, cachexia, metabolic disorders, oncology, or multinational studies advantageous.
• Willingness to travel to study locations.

Responsibilities

• Coordinate trial activity at participating research centers, including activation and enrollment.
• Oversee daily work of CROs and service providers; address missed commitments.
• Guide site initiation and protocol rollout; update needed documents and budgets.
• Use study indicators to recognize trends and mitigate risk.
• Visit clinical sites with CROs to review patient pathways and remove obstacles.
• Partner with site-engagement teams to run location-specific recruitment initiatives.
• Review study financial activity; work with finance and legal on discrepancies.
• Monitor trial master file completeness and support audit readiness.
• Facilitate cross-functional discussions and track unresolved issues.
• Contribute to feasibility assessments and planning for new protocols.

Education

Bachelor's degree in life sciences, nursing, healthcare, or a comparable field

Tools

CTMS

eTMF

EDC

Job description

**This role is 100% onsite Monday-Friday with domestic and international travel required**

The Opportunity

A growing biotechnology organization is seeking an experienced clinical operations professional to oversee the practical delivery of active studies and help prepare upcoming trials. This individual will connect internal stakeholders with outsourced research partners, maintain accountability for execution, and keep study activities aligned with schedule and financial expectations.

This is a highly engaged, site-facing position rather than a purely desk-based oversight role. The successful candidate will be comfortable visiting research centers, working directly with investigators and coordinators, identifying bottlenecks, and driving workable solutions.

What You Will Do

• Coordinate trial activity at participating research centers, including activation, enrollment, ongoing operations, site milestones, and site-level spending.
• Oversee the daily work of contract research organizations and other service providers; evaluate deliverables, address missed commitments, and elevate significant concerns with recommended next steps.
• Guide site initiation and the operational rollout of protocol revisions, ensuring associated documents, agreements, training, technology, and budgets are updated.
• Use study indicators covering start-up, patient screening, accrual, trial conduct, and data delivery to recognize trends and organize risk mitigation.
• Conduct visits to clinical sites, sometimes with CRO representatives, to assess patient pathways, meet study personnel, and remove obstacles to performance.
• Partner with clinical operations and site-engagement teams to carry out location-specific participant recruitment initiatives and measure their effectiveness.
• Review study-related financial activity, including vendor billing, projections, scope changes, and site agreement adjustments; collaborate with finance and legal on discrepancies.
• Monitor completeness of essential records and electronic trial master files; partner with quality and external teams to address deficiencies and support audit preparedness.
• Facilitate cross-functional operating discussions, communicate decisions and action items, and maintain visibility into unresolved site and partner issues.
• Contribute to feasibility assessments, selection of outside providers, planning for new protocols, and scalable clinical operations practices.

What You Bring

• Bachelor's degree in life sciences, nursing, healthcare, or a comparable field; graduate education is a plus.
• At least five years in clinical research, with demonstrated ownership of trial management activities and study execution.
• Experience directing CROs or external vendors, either in a sponsor environment or in a CRO leadership capacity, and familiarity with sponsor oversight.
• Exposure to site activation, trial conduct, amendment implementation, and study closeout.
• Firsthand experience visiting research sites and collaborating with investigators and study coordinators; a background as a CRA or site coordinator is desirable.
• Understanding of clinical site workflows and participant logistics, with confidence engaging physicians and site personnel; nursing experience is beneficial.
• Ability to manage study schedules, costs, and risks while personally following operational problems through resolution.
• Working knowledge of Good Clinical Practice and clinical platforms including CTMS, eTMF, and EDC.
• A resourceful, detail-oriented approach suited to a smaller biotechnology setting, with strong communication and project coordination skills.
• Experience in obesity, cachexia, metabolic disorders, oncology, or multinational studies is advantageous.
• Availability to travel to study locations and attend investigator and external-partner meetings.