Clinical Trials Manager-B

Stamford Health; Stamford (CT); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Wellness programs

Paid Time Off

Retirement plan (403b)

Tuition reimbursement

Free on-site parking

Childcare partnership

Job summary

Stamford Health is seeking a Clinical Trials Manager to oversee oncology and non-oncology trials and lead a team of coordinators, data specialists, and analysts. The role focuses on protocol review, budgeting, and ensuring regulatory and billing compliance across research operations.

The manager collaborates with legal, CROs, and internal departments to maintain study milestones and accurate financial reporting, while driving process improvements and staff training.

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 with strong organizational, interpersonal and communication skills.

Responsibilities

• Oversee Oncology and non-Oncology clinical trials department and staff.
• Review contracts, consent forms, budgets, amendments, and related documentation for appropriateness.
• Coordinate with SH legal, CRO/Sponsor, and billing to ensure compliance and proper billing practices.
• Negotiate budgets and scope of work; manage study milestones and reporting.
• Monitor compliance and provide reports on financial status and inflow/outflow of funds.

Skills

Interpersonal skills

Organizational skills

Communication skills

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Benefits

• 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.