Clinical Trials Manager-B

Stamford Health; Stamford (CT); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Comprehensive health insurance

Wellness programs

Paid time off accruals

Tax deferred annuity and 403b pension

Free on-site parking and train station

Childcare partnership with Children’s 

Job summary

Stamford Health is seeking a Manager of the Office of Research to lead oncology and non-oncology clinical trials, overseeing staff and ensuring compliant, efficient operations. You will manage budgets, contracts, and billing, coordinating with legal, CROs, and sponsors.

The role requires strong organizational and communication skills, a bachelor’s degree (masters preferred) and at least five years in healthcare clinical trials.

Qualifications

• Bachelor’s degree required; Masters preferred.
• Minimum five years of relevant clinical trials experience in a healthcare setting.
• Excellent PC literacy with strong organizational and communication skills.

Responsibilities

• Oversee all aspects of the department related to Oncology and non-Oncology Clinical Trials.
• Manage staff including coordinators, data specialists, finance analysts, regulatory coordinators and research assistants.
• Review trial protocols, contracts, consent forms, budgets, amendments and other documentation for appropriateness.
• Liaise between Stamford Health legal, clinical trials program and CRO/Sponsor to ensure document consistency and compliance.
• Negotiate budgets and scope of work; handle incidental expenses not covered under contracts.
• Establish study milestones within each protocol for data collection.
• Coordinate with billing to ensure timely, accurate research-related billing and reporting.
• Instruct and train staff on billing processes and ensure compliance with regulations.
• Oversee invoicing, client billing, and revenue tracking; provide requested financial reporting.
• Receive payments and coordinate with Patient Access to offset client bills with funds received.
• Set client bill parameters and guide departments on billing for research services.
• Monitor compliance of service providers and present financial status.

Skills

Organizational skills

Interpersonal skills

Communication skills

PC literacy

Education

Bachelor’s degree

Masters preferred

Job description

Job Description

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:

• 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


• Free on-site parking and train station shuttle


• Childcare partnership with Children’s Learning Center

Job Description

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.