Senior Clinical Trial Manager

Summary

Join DELFI Diagnostics, a company developing next-generation cancer detection tests, as a Senior Clinical Trial Manager (CTM). You will oversee all aspects of clinical trials, from early development to publication. Responsibilities include managing study operations, vendor relationships, and regulatory compliance. You will collaborate with cross-functional teams and ensure trials are executed according to GCP and ICH guidelines. The ideal candidate possesses a Bachelor's degree in a science-related field and 8+ years of relevant clinical development experience. DELFI offers a competitive compensation package including full medical, dental, and vision coverage, 4 months of paid parental leave, flexible time off, and a 5-day winter break.

Requirements

• Bachelor’s degree (or higher) in science or health-related discipline
• 8 years of relevant clinical development experience in a sponsor (Pharmaceutical or Biotech) or CRO role and bachelor’s degree; or 6 years with a Master’s degree; or 3 years experience with a PhD; or equivalent experience
• Demonstrated experience in the development, implementation, management, and completion of more than one major clinical trial
• Ability to assist in preparation of a clinical development plan, clinical trial design, protocol writing, and essential documents
• Strong understanding of GCPs, ICH, and knowledge of regulatory requirements
• Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization
• Ability and willingness to travel 10%-15% of the time

Responsibilities

• Manage all clinical aspects of study: budget and metrics; operations; study document development and review (study specific plans, eCRF Guidelines, lab manuals, etc.)
• Assess and recommend CROs and preferred vendors for implementation of clinical studies, and subsequently manage CRO relationships and contracts for study execution, where applicable
• Manage the study submission to IRB in coordination with CRO, as appropriate
• Oversee the execution of site training, either performed by DELFI or CRO partners, and ongoing educational interventions to assure compliance with study protocols
• Ensure clinical trials are executed in compliance with the protocol and ICH/GCP guidelines/regulations: participate in the planning of quality assurance activities and coordinate resolution of audit findings of vendors and CROs; ensure audit-ready condition of clinical trial documentation
• Consult with cross-functional teams on data collection, regulatory questions, and protocol execution as it pertains to the DELFI assay
• Establish and maintain effective communication and collaboration with functional area peers, including research, clinical lab operations team, regulatory, quality assurance, and commercial, as well as thought leaders to meet program objectives

Preferred Qualifications

• Industry experience within in vitro diagnostics (IVD) strongly preferred
• Oncology experience in clinical research
• Clinical experience (oncology, cancer center, inpatient or outpatient or physician office setting) a plus

Benefits

• 100% paid medical, dental and vision premiums for employees and dependents
• 4 months fully paid parental leave
• Flexible Time Off
• 5 day winter break in December
• A meaningful mission and strong company culture
• $130,000 - $185,000 a year