Clinical Contracts Administrator

Role Overview & Key Functions:

• Responsible for drafting, reviewing and negotiating Confidential Disclosure Agreements (CDAs) with US and ex-US healthcare institutions.
• Support legal team with preparation, management and negotiation of routine U.S. and ex-U.S. clinical contract templates (e.g., drafting amendments, extensions and terminations, interpreting contractual language in response to issues or questions that arise)
• Serve in an administrative capacity for all clinical contract matters within the legal department (responsible for QC final drafts, execution process, distributing fully executed contracts, monitoring expiration dates of contracts, and contracts filing in accordance with appropriate records retention procedures)
• Timely tracking, maintenance and updating of company contract management systems to ensure accuracy and compliance with internal procedures and guidelines.
• Responsible for submitting and maintaining all clinical contract related agreements into eTMF systems. Manage the process for uploading, tracking, and managing department documents in eTMF
• Work closely with members of the Clinical Operations, Medical, Finance, Compliance and Site Payment teams and other internal clients, as well as external vendors with respect to specific contract request inquiries
• Ability to follow internal company processes with specific to contracting process guidelines related to contract management systems and department processes; offer and contribute to existing or new department process guidelines to ensure consistencies and improvements
• Other tasks that may be assigned from time to time to support overall function of legal team

*This position will be based in our Newton, MA office and is available for a hybrid work arrangement

Candidate Profile & Requirements:

• B.A. or B.S. degree required
• This role requires a minimum of 2-3 years strong administrative and project management skills as well as the ability to interact with a variety of stakeholders.
• Solid background as a contracts administrator, ideally in a pharmaceutical and/or biotech industry, with experience working cross functionally with business clients.
• Experience working with electronic Trial Master File (eTMF) systems for managing clinical trial documents.
• Ability to prioritize in a fast paced environment on multiple projects with changing priorities.
• Possess an understanding of global clinical development process and clinical operations – an advantage
• Ability to work independently with minimal supervision in a team-oriented environment
• Highly proficient with MS Word, Excel, and Adobe Acrobat.