Senior Site Contracts Specialist - Remote & Global Trials

ERGOMED; Raleigh (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Ergomed is seeking a Senior Specialist, Site Contracts to draft, negotiate, finalize and execute clinical site agreements and amendments during study startup or maintenance. You may act as a local SME and mentor junior staff, supporting the Site Contracts Lead on assigned studies.

You'll collaborate with project management, clinical operations and sites to ensure regulatory compliance, timely delivery and a predictable contracting process across the region or country, with a focus on accuracy

Qualifications

• 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 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

• Draft, negotiate, finalize and execute clinical site agreements, ancillary agreements and amendments at country or regional level.
• Mentor junior staff and support the Site Contract Lead as a local SME.
• Collaborate with project management, clinical management and operations to meet project goals.
• Create a predictable project delivery experience for study teams and sponsors alike.
• Maintain country/regional intelligence and ensure regulatory compliance across assigned studies.

Skills

Communication skills

Attention to detail

Project coordination

Proactive work ethic

Education

Bachelor's/Master's degree in business, law, or life sciences

Job description

Ergomed is seeking a Senior Specialist, Site Contracts to draft, negotiate, finalize and execute clinical site agreements and amendments during study startup or maintenance. You may act as a local SME and mentor junior staff, supporting the Site Contracts Lead on assigned studies.

You'll collaborate with project management, clinical operations and sites to ensure regulatory compliance, timely delivery and a predictable contracting process across the region or country, with a focus on accuracy