Job Description

We are seeking an exceptional leader to join our team with strong background in leading teams through the processes of Budget Development and Clinical Trials negotiations. The ideal candidate will have a proven ability to achieve significant reductions in activation times. Experience in early therapeutics is highly desirable.

Key Responsibilities:

• Lead and mentor teams in the development and negotiation of clinical trial budgets.
• Drive initiatives that enhance activation times and overall project efficiency.
• Collaborate with cross-functional teams to ensure successful trial execution.

Qualifications:

• Strong leadership skills with a history of successful team development.
• Demonstrated experience in clinical trial budget development and negotiation.
• Demonstrated success in improving activation timelines.

The Director, Clinical Trial Business Office is responsible for providing leadership and has general oversight of the Clinical Trial Business Office functions including Contracts, Budgets, Coverage analysis, Clinical Trial Management System calendars and post activation amendments.

The Director, Clinical Trial Business office is the signatory authority to clinical trial agreements, Letter of Indemnification, sub-sites and Master agreements. The Director is responsible for ensuring Clinical Trial Business Office efforts are in compliance with the Center's guidelines, state and federal regulations by monitoring and evaluating the quality and appropriateness of the department activities.

A successful Director, Clinical Trial Business Office promotes and supports the clinical trial infrastructure to advance clinical trial activation, study management and provides support to principal investigators, clinical research and revenue cycle personnel. The Director works proactively and collaborates with various departments across the organization to design efficient and compliant operational workflows to achieve activation and revenue targets.

Minimum Experience Required:

• Minimum of eight (8) years of healthcare or related industry experience in clinical research business functions (contracting, budgeting, negotiating, clinical trial management systems and/or Coverage Analysis development) of academic medical centers.
• Minimum of three (3) years supervisory experience.

Minimum Skills/Specialized Training Required:

• Leadership and mentoring skills necessary to provide support to department and promote employee development.
• Outstanding verbal and written communication skills to support interaction and participation in meetings. with patients, physicians, payer representatives, affiliates, oncology partners, and representatives of another internal department.
• Proven analytical ability and organizational skills necessary to organize/assess information and evaluate recommendations based on data analysis.
• Strong focus on compliance and building a complaint department including establishing working relationships with.

Internal Audit and Corporate Compliance:

• Working knowledge of federal grant management policies and regulation governing sponsored agreements, clinical trial policy and federal billing guidelines.
• Proficient in problem-solving, project management, multi-tasking and time management.
• Proficient business software skills including Microsoft Office.

Preferred Experience:

• Experience in oncology related research operations of large academic institutions and NCI designated cancer center.
• Preferred in-depth knowledge of research business operations, use of technology to improve efficiency of operations and an advocate of change leading to improved processes.

Preferred Skills/Specialized Training:

• Advarra Research System's Oncore Clinical Trials Management System knowledge.
• Cerner Millennium knowledge.
• Cerner Soarian Financials knowledge.

Minimum Education:

• Bachelor's Degree Business, Public Health, Healthcare related or similar field.

Preferred Education:

• Master's Degree MBA, MHA, scientific related.
• Master's degree.

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