Clinical Study Manager

Foresight Diagnostics Inc. • Boulder, CO

1d • $150,000 - $170,000 • Hybrid

About The Position

The Clinical Study Manager, under the Director of Clinical Operations, will oversee, execute, and report on clinical study operations for Foresight Diagnostics’ research projects (to include companion diagnostic studies, Investigator Initiated studies, and internally sponsored studies). The Clinical Study Manager works to ensure that assigned studies are executed with quality and efficiency, in accordance with timelines and budget to support broader company strategic objectives. They will be responsible for study start-up planning, study conduct, and site/partner management according to partnership agreements and investigational plans. The Clinical Study Manager will collaborate closely with biopharmaceutical companies and research institutions seeking precision oncology assays to evaluate minimal residual disease (MRD) and a partner to execute diagnostic projects. They will also provide support to members of Foresight’s multidisciplinary project team, including the clinical laboratory team, bioinformatics, regulatory, medical affairs, and operations support. Activities will include proactive, clear and customer-centric communication, day to day project management, and operational excellence.

Requirements

• Bachelor’s degree or equivalent in scientific field or equivalent combination of education, training and experience
• 5+ years clinical trial experience in the biopharmaceutical or diagnostic industry or an academic medical center
• 3+ years of experience leading project operational teams through the start-up, study conduct, data management, and report writing/review of clinical studies.
• Experience working at or with Clinical Research Organization (CRO) or lab vendor environment or biopharmaceutical companies
• Good knowledge of Good Clinical Practices and all applicable U.S. regulations governing clinical research with documentation of GCP training.
• Working knowledge of the FDA submission process including IDE, PMA, and 510(k).
• International Study experience and GDPR implementation.
• Experience handling complex clinical data sets including genomic data
• Confident, self-starter capable of taking ownership of tasks
• Attention to detail with pride in delivering an excellent work product
• Strong organizational and planning skills; ability to complete assignments in a timely manner
• Demonstrated evidence of success working in a cross-functional environment
• Excellent verbal and written communication skills; including email responsiveness and strong customer service skills
• Proficient in MS Office suite

Responsibilities

• Implement and assume primary accountability for clinical study protocols and operational plans, which are consistent with strategic corporate objectives.
• Manage and lead the day-to-day operations of assigned studies to ensure compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Coordinate clinical study timelines with cross-functional teams to meet critical milestones; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
• Provide oversight and direction to study team members (Clinical Research Associate, Project Coordinator) for study deliverables.
• Train partners, sites, and internal study team members to the study protocol, study plans, and applicable guidelines and regulations.
• Co-develop and manage (review, revision, tracking and filing) of study materials, including study plans, protocols, informed consents, training materials, and data collection forms/guidelines.
• Oversee eTMF to ensure compliance/inspection readiness.
• Lead assigned meetings (cross-functional (internal) and/or partner) e.g., agenda development, minutes curation and filing; effectively track and communicate project progress to partners with the ability to create and update detailed dashboards and trackers.
• Support process improvement initiatives or serve as a subject matter expert and/or mentor.

Benefits

• Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level