Clinical Study Manager

Summary

Join Foresight Diagnostics, a venture-backed molecular diagnostics company, as their Clinical Study Manager. You will oversee clinical study operations for research projects, ensuring quality and efficiency in accordance with timelines and budget. Responsibilities include study start-up planning, conduct, and site/partner management. Collaboration with biopharmaceutical companies and research institutions is key, as is support for Foresight's multidisciplinary project team. The role demands proactive communication, project management, and operational excellence. This position offers a competitive salary and benefits package, including paid time off, parental leave, health insurance, and a 401k with company match. Professional development and upward mobility are encouraged.

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

• Paid vacation
• Sick time
• Parental leave (if applicable)
• Medical, dental, vision, life, disability coverage
• Flexible spending accounts
• A 401k with company match