MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner, IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together, we support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and post-market optimization. Our teams combine deep therapeutic knowledge with advanced data and technology to help clients make smarter decisions and thrive in the market. Join our team to help shape the future of MedTech.
The Associate, Clinical Contracts and Budgets will be a critical team member supporting the negotiation of clinical trial agreements and site budgets on behalf of MCRA, an IQVIA Business sponsor clients engaged in clinical research of varying design and therapeutic areas.
Responsibilities and Duties
Work 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.
Collaborate with sponsor management and sponsor legal teams, as well as physicians, hospitals, institution legal counsel and MCRA, an IQVIA Business clinical team, to finalize contracts and budgets for clinical research on a daily basis across multiple studies of varying design, scope and therapeutic area.
Monitor the business, financial and legal risk in contracts and related documents and communicate these risks to clinical trial study sponsors.
Collaborate with compliance division to ensure budgets are aligned with fair market value. Ensure compliance with HIPAA regulations and requirements.
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).
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.
Research salient regulatory issues impacting the conduct of clinical research, including Anti-Kickback, Sunshine Act, Medicare Secondary Payer statutes, etc.
Work collaboratively with other MCRA , an IQVIA Business departments, including clinical, regulatory and compliance.
Required Knowledge, Skills, and Experience
Education: Bachelor’s degree in a scientific discipline or health policy; JD preferred.
Experience: 1-5 years’ experience in contract negotiations or health law policy.
Strong attention to detail and the ability to work both individually and collaboratively within a multi-disciplinary team, as well as with external partners and vendors.
Possesses strong written and verbal communication and presentation skills.
Ability to comprehend technical medical language and dissect clinical research protocols.
Strong research, analytical and problem-solving skills.
Strong legal drafting skills.
Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.
PC/Technical skills- MS Office, Excel, Word, PowerPoint.
Must be punctual, polished, and professional.
Effective interpersonal skills: shows confidence with subject matter and “calm under pressure” approach and style.
Strong professionalism with client and site relations and managing client relationships.
Travel required
Travel (10%) is required for this role.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $54,800.00 - $136,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.