Clinical Trial Manager - Site & Risk Leader

Syneos Health/ inVentiv Health Commercial LLC; Sioux Falls (SD); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Company car

Health benefits

401k match

Stock Purchase Plan

Bonus eligibility

PTO & sick time

Job summary

Syneos Health in Sioux Falls, SD is seeking a Clinical Trial Manager for full service operations. You will lead site management, monitoring activities, and data integrity efforts to ensure patient safety and regulatory compliance.

You will drive risk assessments, coordinate with functional teams, and oversee CTMS/EDC/TMF systems across studies. The role emphasizes leadership, collaboration, and delivering milestones in a fast paced biopharma environment.

Qualifications

• Bachelor's degree or RN in related field or equivalent combination of education, training, and experience.
• Ability to lead and align teams to milestones in global studies.
• Strong knowledge of GCP/ICH guidelines and regulatory requirements.

Responsibilities

• Oversee site management, clinical monitoring, and central monitoring with focus on patient safety and data integrity.
• Review scope, budget, and protocol content; identify risks to deliverables and escalate as needed.
• Develop and implement risk mitigations; participate in Kick Off Meetings and key study reviews.
• Serve as escalation point for investigator/site communications and coordinate with PI staff as needed.
• Coordinate with Study Start Up, Patient Recruitment, and Data Management to meet milestones like site activation and database lock timelines.
• Develop and maintain clinical study tools and templates, ensure CTMS/EDC/TMF systems are ready and auditable.
• Coordinate training for the study team on protocol specifics, CRF completion, dashboards, SOPs, and timelines.
• Oversee resourcing for CRAs and Central Monitors and ensure progress visibility via tracking tools.
• Provide status updates to clients and leadership on deliverables and risks; suggest solutions for obstacles.

Skills

Team leadership

Risk management

Regulatory compliance

Problem solving

Clinical monitoring

Data integrity

Education

Bachelor's degree or RN in related field

Tools

CTMS

EDC

TMF

Job description

Syneos Health in Sioux Falls, SD is seeking a Clinical Trial Manager for full service operations. You will lead site management, monitoring activities, and data integrity efforts to ensure patient safety and regulatory compliance.

You will drive risk assessments, coordinate with functional teams, and oversee CTMS/EDC/TMF systems across studies. The role emphasizes leadership, collaboration, and delivering milestones in a fast paced biopharma environment.