The Contract & Budget Manager will work closely with our various study sponsors, physicians, hospitals, legal counsel and MCRA’s clinical team to develop, draft and negotiate clinical trial agreements and clinical research budgets on behalf of the applicable sponsor client. Requires 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 Reimbursement, Health Economics and Market Access and will work closely with the Senior 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.
Communicate regularly with physicians, site coordinators, billing staff, hospital personnel, legal department, study sponsor executive leadership and MCRA CRO team.
Work across multiple studies of varying design and therapeutic areas to support MCRA’s 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.
Knowledgeable of and ensures compliance with HIPAA regulations and requirements.
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.
Stay abreast of current trends in compliance, coding and reimbursement and their impact on clinical trial budgets through continuing education and coding forum reviews.
Other Projects and duties as assigned
Remote opportunity possible for well-qualified candidate
3-5 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. MCRA 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 for 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
Ability to travel Up to 10%.
Internal Number: 3001
About MCRA, LLC
Founded in 2004, MCRA is a leading medical device advisory firm and clinical research organization (CRO). MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. MCRA's integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves more than 600 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, dental, general healthcare, digital health, neurology, robotics, and in vitro diagnostic (IVD) devices.