Sr. Associate/Manager of Budgets and Contracts
Sr. Associate/Manager of Budgets and Contracts
We are the leading industry-specialized, multi-service, employee-based, integrated business that assists clients in the entire technology life cycle, from research and development, through commercialization. Our team provides services to a wide range of organizations in the healthcare industry, including start-ups to the world's leading healthcare organizations, as well as all types of financial investors, global manufacturers, and individuals
The Contract & Budget Sr. Associate/Manager will work with the study sponsor, physicians, hospitals, legal counsel and our clinical team to draft, develop and negotiate clinical trial agreements and clinical research budgets on behalf of the sponsor client. Collaboration with sponsor management and legal teams to finalize contracts and budgets for clinical research on a daily basis across multiple studies of varying design, scope and therapeutic area. Extensive experience interacting effectively and efficiently with investigators, counsel, executive leadership, and cross-functional teams is a must. The position will report to the Director of Health Economics, Reimbursement & Public Policy and will work closely with the Director of Clinical Affairs and the Vice President of Healthcare Compliance.
- Works with outside counsel and sponsor counsel to develop clinical trial agreement templates and study budget templates for clinical trials of varying design and therapeutic areas.
- Streamline clinical trial agreement negotiation between investigative sites and study sponsors.
- Coordinate regularly with sponsor legal/management teams and monitors the business and legal risk in contracts and related documents. Communicates these risks to clinical trial study sponsor.
- Work with study teams to develop clinical trial investigator budgets and overall administrative budget. Collaborate with compliance division to ensure budgets are aligned with fair market value.
- Work with sponsor legal team and site legal team to identify acceptable alternative/fallback language for clinical trial agreements and relative sections of the subject informed consent form (ICF).
- Manage budget negotiations with investigator sites. Escalate site requests as needed to the study CRO team and Sponsor management for decision-making.
- Work across multiple studies of varying design and therapeutic areas to support our CRO team.
- Track status of clinical trial agreements, clinical trial investigator budgets, and ICF approvals across multiple clinical studies.
- Maintain documentation of all contract and budget correspondence and status.
- Manage changes to contracts/budgets and ICFs throughout the duration of multiple clinical studies.
- Ensure final documents are filed, maintained and archived in the appropriate location.
- Knowledgeable of and ensures compliance with HIPAA regulations and requirements.
- Communicate regularly with physicians, site coordinators, billing staff, hospital personnel, legal department, study sponsor executive leadership and our clinical research team.
- Stay abreast of current trends in compliance, coding and reimbursement and their impact on clinical trial budgets through continuing education and coding forum reviews.
- Contribute to the development of ad hoc clinical trial reimbursement resources and site training on billing/reimbursement processes during clinical research.
- Assist clinical research sites with understanding the appropriate reimbursement pathways and processes during clinical research.
- J.D. preferred.
- 2-5 years' experience managing and negotiating clinical trial contracts and budgets at either the sponsor, CRO, or provider (physician, practice, hospital or academic university) level.
- Ability to read, analyze, and interpret complex legal contracts and communicate key issues to sponsor clients.
- Strong understanding of legal issues and risks pertaining to clinical research contract drafting and administration.
- Knowledge of medical terminology and coding methodologies preferred.
- Familiarity with family of medical code systems, HCPCS, CPT, RBRVS, ICD-10CM/PCS, DRGs preferred. We will incorporate basic training into position responsibilities when required.
- Knowledge of clinical trial management, billing code systems and claims processing.
- Proficiency with MS Office Suite and Internet applications.
- Ability to work on activities 3-5 studies at any given time.
- Understanding of medical terminology and confidence when speaking with investigators and medical staff.
- Excellent quantitative and analytical skills.
- Ability to work independently and handle confidential information.
- Excellent oral and written communication skills with experience in presenting analysis to clients.
- Travel up to 10%
- Health Benefits (Medical, Dental and Vision)
- AD&D Insurance
- Short and Long-Term Disability
- 401(k) Retirement Plan
- 12.5 Paid Holidays
- Commuter Benefits
- Supplement Insurance at discounted rates through MetLife and Aflac
Depending on experience
Please email your resume to firstname.lastname@example.org
NRI is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.