Clinical Trials Manager-B at Stamford Health in Stamford, CT

Under the direction of the Director, Office of Research, the Clinical Trials Manger manages staff including clinical trials coordinators, data specialists, finance analysts, regulatory coordinators and research assistants, and any other staff deemed necessary for the successful operation of clinical trials.

This role directs and oversees all areas of Clinical Trials.

As a Certified Great Place to Work organization, Stamford Health understands what it takes to attract talent to improve our workforce and support our mission, to that end we offer: • Competitive salary • Comprehensive, low-cost health insurance plans (including GLP-1 coverage options) available day one • Wellness programs • Paid Time Off accruals • Tax deferred annuity and (403b) pension plan • Tuition reimbursement • Free on-site parking and train station shuttle • Childcare partnership with Children’s Learning Center

Regular, Full Time Schedule (Monday-Friday, 37.5 Hours per week)

Responsibilities:
Under the direction of the Director of the Office of Research, the manager oversees all aspects of the department as they relate to management of Oncology and non-Oncology Clinical Trials. The department manager manages staff including clinical trials coordinators, data specialists, finance analysts, regulatory coordinators and research assistants, and any other staff deemed necessary for the successful operation of clinical trials • Seeks trial opportunities and/or receives, reviews and presents protocols for consideration by physicians. Reviews CDA and manages CDA process. • Reviews contract, consent, budget, amendments, and other modifications to documentation for appropriateness. • Acts as liaison between SH legal, clinical trials program and CRO/Sponsor to insure consistency of documents and compliance with department/institution's operating procedures. • Negotiates budgets and affiliated scope of work. Also negotiates incidentals not covered under contract as necessary. • Establishes study milestones within each protocol for collection purposes. • Works closely with department's billing supervisor and department administrator to insure that research billing meets government and institutional guidelines, is billed timely and correctly. • Trains staff to correctly report billing activity and monitors compliance with rules. • Interfaces with billing department to prevent duplicate or missed billing. • Maintains accurate and detailed accounting of inflow and outflow of funds through invoicing, client bill and income due from contractual agreements. Provides reporting as requested. • Receive payments, identify appropriate disbursement of funds and work with Patient Access Supervisor to insure client bills are offset by funds received. • Establish client bill parameters with other departments and properly instruct departments on billing of their services. Also give clear instruction to outside providers billing for services related to research. • Monitor compliance of both service provider types. • Analyzes and presents financial status.

Qualifications: • Bachelor’s degree required (Masters Preferred) • Five years of prior relevant experience in an equivalent healthcare setting involving clinical trials. • Exceptional computer literacy in a PC environment is required with strong organizational, interpersonal and communication skills.