Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality disclosure agreements (CDA), initial clinical trial agreements (CTA), amendments to the clinical trial agreements (CTA-A), site budgets 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 (CDA), Clinical Trial Agreements (CTA) and Amendments (CTA-A), 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)
• Lead interactions regarding assigned agreements with the Sponsor(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 and sponsors 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:
• Bachelor’s degree, or equivalent contract management experience preferably in a clinical
research or similar industry setting
Other Required:
• 3 years of relevant experience drafting, reviewing and negotiating agreements related to clinical research i.e. Non-Disclosure Agreements, Clinical Trial Agreements, etc. as well as management, control and tracking of the contract process.
• Experience in contract research, life science, biotech or pharmaceutical industry is preferred.
• Experience interacting with European institutions.
Preferred:
• Equivalent contract management experience in a clinical research or similar industry setting
• Experience in contract research, life science, biotech or pharmaceutical industry.
Skills:
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 Mentor and/or Ambassador for new Contract and Budget Associates and PFM staff
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