Reports to: Contracts Manager
Position Summary
The Clinical Contracts Temp will support our Clinical Operations and Legal teams by managing contract amendments and ensuring documentation accuracy. This role requires someone who is proactive, efficient, and capable of working independently under guidance. This is a hybrid role requiring 2-3 days in the office in Burlington, MA, with the remainder remote.
Primary Responsibilities
- Draft, review, and process amendments to clinical trial agreements, including updating and finalizing clinical budgets.
- Ensure accuracy and compliance with company policies and legal standards.
- Maintain organized records and track the status of agreements.
- Communicate effectively with internal stakeholders and external parties as needed.
- Follow detailed instructions and complete tasks within set deadlines.
- Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.
- Bring a “can do” spirit to work and deliver on other responsibilities as assigned.
Education or Certification Requirements
- Associate’s or Bachelor’s degree preferred.
Professional Work Experience
- 2-3 years minimum relevant experience required
- Experience with regulatory and clinical submission associated paperwork preferred.
- Applicable experience in biotech, pharmaceutical and/or medical device industries preferred.
- Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
Qualifications and Skills
- Strong attention to detail and excellent organizational skills.
- Ability to work independently while taking and implementing instructions effectively.
- Prior experience in one or more of the following roles is preferred:
- Legal Secretary
- Paralegal
- Clinical Contracts Specialist (within a Clinical Operations team)
- Familiarity with clinical trial documentation is a plus.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
Other Essentials and Key Success Factors
- Successful track record of working in high-growth and dynamic organizations
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Proven and successful track record as a team-player and collaborator in small working environments
- Highly organized and detail oriented with a passion to deliver quality results
- Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
- Highest levels of professionalism, confidence, personal values and ethical standards
Travel
This position requires no regular travel.
The description and requirements outlined above are general; additional requirements may apply.
