Clinical Trials Manager-B

Responsibilities

• Oversees all aspects of the department as they relate to management of Oncology and non-Oncology Clinical Trials.
• 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.
• Sets up 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 ensure 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 ensure 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 ensure 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.
• Maintain 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.