Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality disclosure
agreements (CDA), amendments to the clinical trial agreements (ACTA) and other various types of
documents. Will work closely with the Clinical Operations study team and play an administrative role to
ensure deliverables are in alignment with defined project timelines and expectations.
Essential functions of the job include but are not limited to:
• Prepare and negotiate Agreements/Amendments such as Confidentiality Disclosure
Agreements, Amendments to Clinical Trial Agreements, vendor contracts and site budgets
• Lead interactions with the North American and European internal study teams, as applicable
• Lead interactions regarding the various agreements with the Site(s)
• Work with supervisor and various internal/external stakeholders to resolve contractual issues
• Ensure adhered to company policies, procedures, and contracting standards
• Update relevant study team members regarding the status of contract negotiations and
execution
• Coordinate execution of the agreements
- Support the maintenance of contract files and databases, including email and document
archiving
• Other duties as assigned
Qualifications:
Minimum Required: 4-year college degree, or equivalent contract management experience
Other Required: Minimum 1 year of experience or relevant experience in drafting, reviewing, and
negotiating site agreements such as CDAs and Amendments to CTAs
Preferred:
• Equivalent contract management experience in a clinical research or similar industry setting
• Experience in contract research, life science, biotech or pharmaceutical industry.
Competencies
- Excellent organizational and communication skills and attention to detail
• Experience in tracking status for site contracts and budget, filing and distribution
• Executes time-sensitive matters while maintaining accuracy and attention to detail
• Exhibits high self-motivation and is able to work and plan independently or with limited
supervision
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to
deliver on commitments and understanding of the service culture and positive interactions
with customers
• Proficient in MS Office Software programs and computer applications
• Works well independently and cooperatively with others to achieve common goals in a
virtual environment
• Develops, maintains and strengthens relationships with others inside or outside of the
organization who can provide information, assistance and support
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