Job Title:Clinical Project Manager
Duration: 6 months 
Location: Minneapolis Minnesota 55111 - remote role 
Open to remote candidates based in Eastern Standard Time Zone

JOB SUMMARY

The Clinical Project Manager is responsible for planning, managing, and executing medical device clinical studies from start to finish. This includes study design support, site activation, study oversight, compliance management, and study closeout. The role ensures studies are completed on time, within budget, inspection-ready, and compliant with regulatory and quality standards. The CPM works cross-functionally and manages CROs, vendors, and clinical sites to support both pre-market and post-market clinical evidence needs.

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JOB DESCRIPTION

The Clinical Project Manager leads end-to-end execution of clinical trials, ensuring operational excellence, regulatory compliance, and high-quality data delivery. This role manages timelines, budgets, vendors, risk mitigation, and cross-functional communication throughout the study lifecycle.

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Key Responsibilities

Study Planning and Start-Up

• Lead site feasibility, selection, and investigator qualification activities.

• Support development and review of study documents (protocols, informed consent forms, monitoring plans, CRFs, EDC input, study manuals).

• Coordinate study start-up activities including vendor selection, contracts, IRB/EC submissions, site activation, and study training.

• Partner with Medical Affairs and Regulatory teams to support U.S. and global regulatory submissions.

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Study Execution and Oversight

• Provide full operational oversight of clinical studies across sites and vendors.

• Track enrollment, timelines, milestones, and study metrics.

• Manage CRO/vendor performance and lead governance meetings.

• Identify risks early and implement mitigation strategies.

• Deliver executive-ready study updates, dashboards, and status reports.

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Quality, Compliance, and Inspection Readiness

• Ensure compliance with GCP, regulatory requirements, and internal SOPs.

• Oversee TMF/eTMF documentation to maintain audit readiness.

• Manage protocol deviations and support CAPA activities.

• Coordinate with Quality and Safety teams on adverse event reporting and reconciliation processes.

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Data Review and Clinical Evidence Support

• Support clinical data review, cleaning, and interpretation.

• Contribute to clinical study reports and regulatory documentation.

• Compile post-market clinical data to support lifecycle management.

• Assist with documentation for Design History File (DHF) and regulatory filings.

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Additional Responsibilities

• Support other company-sponsored clinical initiatives as needed.

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Education and Experience

• Bachelor’s degree (Life Sciences preferred) or equivalent experience.

• 5+ years of clinical research experience (medical device or pharmaceutical).

• 2+ years of direct project management experience preferred.

• Experience managing CROs, vendors, and multi-site studies preferred.

• Experience with device trials and IRB/EC processes required (IDE experience a plus).

• Endocrinology or diabetes experience highly preferred.

• Strong analytical, organizational, and interpersonal skills.

• Knowledge of regulatory guidelines and compliance requirements.

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Skills and Competencies

• Strong project management and execution skills.

• Excellent written and verbal communication abilities.

• Risk identification and problem-solving mindset.

• Proficient in Microsoft Office and clinical trial systems (EDC, eTMF).

• Able to work in fast-paced, cross-functional environments.

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Travel Requirements

• Approximately 10% domestic and international travel.

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Work Arrangement

Hybrid role – may require occasional work from company office, clinical trial sites, or remote locations.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 70.00/hr.