- Is responsible for preparing, negotiating, tracking and finalizing the Confidentiality Agreements (CDA), Clinical Trial Agreements (CTA), Budgets and Letters of Indemnification (LOI) as well as Amendments to these documents, as needed.
- Negotiates final CDA and CTA templates with clients, and the internal project team.
- Manages all required contractual agreements with investigator sites. This includes distribution, negotiation of budget and language, tracking and finalization.
- Proactively identifies site contract related risks and potential roadblocks.
- Prepares contract approval timelines with investigators and leads efforts to obtain contract approval to meet study deliverables.
- Maintains consistent communication with client, project team and sites regarding status of all contractual requirements to ensure client deliverables and expectations are achieved.
- Liaises with internal customers to review contract or budget areas that impact final execution of site contracts.
- Maintains tracking regarding site contracts and budgets and provides regular updates to the project team and client regarding status and efforts to ensure timelines are maintained.
- Provides training on clinical site contractual requirements and negotiation.
- Participates in corporate initiatives and actions that ensure the continued success of the company.
- Bachelors degree in Business Administration, Supply Chain/Vendor Management, Legal Studies, or Life Sciences;
- CRO experience required;
- 3+ years of investigator site contract experience negotiating site agreements;
- Ability to work with internal and external customers/vendors to meet project-specific goals;
- Time-management-- Ability to manage high volume work and meet rigorous deadlines;
- Flexibility to strategically manage negotiations with minimal oversight;
- Exceptional communication skills-- Ability to interact with site, clients, and other functional areas as secondary project contact for contracting issues and questions; and
- Organization-- Ability to handle time and project requirements based on study deliverable.
- Dallas Campus Overview
- Hybrid work-from-home options (dependent upon position and level)
- Competitive PTO packages, starting at 20+ days
- Competitive compensation and benefits package
- Flexible work schedule
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
- Community involvement with nonprofit organizations
- Structured career paths with opportunities for professional growth
- Discounts on local sports games, fitness gyms and attractions
- Modern, ecofriendly campus with an on-site fitness center
- Free on-site parking
- Outdoor seating and workspace?
- Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
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Experienced Contract Specialist - Irving, United States - Medpace
Description
Job Summary:Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, Lead Contract Specialist to join our Clinical Operations team. This position plays a key role in the study start-up and clinical trial management processes at Medpace. The Contract Specialist will play a key role in advancing the start-up of our projects. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
Responsibilities :Travel: None
Medpace Overview :Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?:People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work weve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Dallas Perks
Awards
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
