Senior Site Contracts Specialist

Overview

This role manages the site contracting process locally or across a region in support of assigned clinical projects. Responsibilities include drafting, negotiating, finalizing, and executing clinical site agreements, ancillary agreements, and amendments during study startup or maintenance. The position also supports the Site Contract Lead as a local subject matter expert and may mentor more junior staff within the Study Start Up and Regulatory Department. On some studies, the role may lead site contracting activities at the study level.

Responsibilities

• Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments at country or regional level in accordance with project requirements and country regulations, and within projected delivery timelines.
• Track site contracting progress in a timely manner during Study Start Up or maintenance, providing clear rationale for delays, along with contingency plans to mitigate impact; escalate issues as soon as identified.
• Collaborate with the Site Contracts Lead, project management, clinical management, and clinical operations personnel to achieve project goals.
• Ensure a predictable project delivery experience for both study teams and clients.
• Serve as a country or regional subject matter expert for site contract agreement (CSA) elements for assigned studies for internal and sponsor stakeholders.
• Keep country intelligence up to date in country intelligence repositories.
• Provide mentorship to more junior staff within the Study Start Up and Regulatory Department.

Qualifications

• Undergraduate or graduate degree in business, law, or life sciences, or equivalent combination of education and experience.
• Extensive experience negotiating CSAs and Investigator grants (preferably above 4 years).
• Good knowledge of applicable regulations, drug development, and clinical project management procedures.
• Good understanding of specific country requirements pertaining to Site Contracts delivery in the Americas.
• Remarkable attention to details.
• Effective oral and written communication skills.
• Ability to work proactively and effectively to meet project deadlines.
• Good interpersonal skills.
• Resilience and ability to manage multiple tasks, set priorities, and adapt in changing work assignments.
• Ability to exercise sound judgment and make decisions independently.

Location

U.S. Hiring Locations: Florida, Georgia, South Carolina, North Carolina, Virginia, New York, Tennessee, Texas, Ohio, remote