Senior Site Contracts Specialist

Ergomed • Raleigh, NC

2d • Remote

About The Position

The Senior Specialist, Site Contracts will manage the site contracting process locally or across a region in support of assigned projects by drafting, negotiating, finalizing and execution clinical site agreements, ancillary agreements or amendments during study startup or maintenance. The Senior Specialist, Site Contracts will also support the Site Contract Lead as a local subject matter expert in all matters related to Site contracts in countries or region of assignment and may act as a mentor to more junior staff within the Study Start Up and Regulatory Department. The Senior Specialist, Site Contracts may also lead Site Contracting activities on a study level.

Requirements

• Undergraduate or graduate degree in business, law, or life sciences or equivalent combination of education and experience.
• Extensive experience in 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/ 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 judgement and to make decisions independently

Responsibilities

• Responsible for drafting, negotiating, finalizing, and executing clinical site agreements, ancillary agreements as well as amendments at country or regional level, in accordance with project requirements and country regulations, and within the projected delivery timelines
• Tracks in a timely manner progress of Site contracting activities during Study Start Up or Maintenance and provides clear rational for delays, as well as a contingency plan to mitigate their impact, and escalates any issues as soon as identified.
• Collaborates with the Site Contracts Lead, project management, clinical management, and clinical operations personnel to achieve project goals.
• Responsible for creating a predictable project delivery experience for both study teams and clients alike.
• Acts as country or regional subject matter expert for all such CSA elements on assigned studies for internal and sponsor stakeholders alike and ensures country intelligence is up to date in country intelligence repositories.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior