Overview
This role involves reviewing, drafting, negotiating, and tracking a range of legal agreements, including confidentiality disclosure agreements (CDAs), initial clinical trial agreements (CTAs), amendments to clinical trial agreements (CTA-A), site budgets, and other related documents. You will work closely with the Clinical Operations study team and provide administrative support to ensure contract deliverables align with defined project timelines and expectations.
Responsibilities
- Prepare and negotiate agreements and amendments, including:
- Confidentiality Disclosure Agreements (CDAs)
- Clinical Trial Agreements (CTAs) and amendments (CTA-A)
- Vendor contracts and site budgets
- Lead interactions with internal study teams in North America and Europe, as applicable
- Lead communications with study sites regarding assigned agreements
- Lead communications with sponsors regarding assigned agreements
- Work with the supervisor and internal/external stakeholders to resolve contractual issues
- Ensure adherence to organizational policies, procedures, and contracting standards
- Provide updates to study team members and sponsors on the status of contract negotiations and execution
- Coordinate execution of agreements
- Maintain contract files and databases, including email and document archiving
- Perform other duties as assigned
Requirements
- Bachelor’s degree, or equivalent contract management experience, preferably in a clinical research or similar industry setting
- 3 years of relevant experience drafting, reviewing, and negotiating agreements related to clinical research (e.g., non-disclosure agreements, clinical trial agreements), including management, control, and tracking of the contract process
- Experience interacting with European institutions
- Experience in contract research, life science, biotech, or pharmaceutical industry is preferred
Preferred Qualifications
- 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 with strong attention to detail
- Experience tracking status for site contracts and budgets, including filing and distribution
- Ability to execute time-sensitive tasks while maintaining accuracy
- High self-motivation and ability to work independently or with limited supervision
- Professionalism demonstrated through punctuality, ability to deliver commitments, and positive customer interactions
- Proficiency in MS Office and other computer applications
- Ability to work independently and collaboratively in a virtual environment
- Ability to develop, maintain, and strengthen relationships with internal and external partners who can provide information, assistance, and support
- Ability to mentor and/or serve as an ambassador for new Contract and Budget Associates and other staff
Compensation & Benefits
- Estimated compensation range: $68,700—$103,700 USD
- Discretionary annual bonus eligibility
- Health insurance
- Retirement savings benefits
- Life insurance and disability benefits
- Parental leave
- Paid time off for sick leave and vacation
- Other benefits as applicable
Location
- Remote (US-based legal authorization required)
Additional Notes
- Candidates must be legally authorized to work in the country of employment without employer sponsorship.