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Medpace · 2 days ago

Experienced Contract Specialist (Dallas)

Irving, TX

Full-time, Contract

Onsite

Mid, Senior Level

3+ years exp

Medpace is a full-service clinical contract research organization (CRO) that provides clinical development services to the biotechnology, pharmaceutical, and medical device industries. They are seeking a Lead Contract Specialist to play a key role in the study start-up and clinical trial management processes, focusing on preparing, negotiating, and finalizing various contractual agreements.

BiotechnologyPharmaceutical

Responsibilities

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

Qualification

CRO experienceInvestigator site contract experienceNegotiation skillsTime managementCommunication skillsOrganizational skillsFlexibility

Required

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

Organization-- Ability to handle time and project requirements based on study deliverable