Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management.
Essential functions of the job include but are not limited to:
- Establish process and procedures for overall site contract management in the organization.
- Review, draft and negotiate a variety of agreements including master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts.
- Escalate and resolve complex issues with clients and internal stakeholders.
- Negotiate site budget.
- Provide guidance to business teams regarding operational implications of contract terms.
- Ensure adherence to company policies, procedures and contracting standards.
- Update relevant study team members regarding the status of contract negotiations and execution.
- Establish, track, report and manage site contract metrics.
- Coordinate execution of agreements and track agreement expirations and other obligations
- Support the maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
- Recognize where processes can be improved and take corrective action.
- Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
- Other tasks, as assigned.
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree
- Equivalent experience ideally in a scientific or healthcare discipline
- Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements, vendor contracts and site Budget negotiations, but no less than 7 years’ experience.
- Experienced leading interactions with US/European/APAC or other regions institutions
- Experienced leading interactions with Study Teams and Sponsor
Preferred:
- Bachelors in law, scientific fields, business administration or equivalent degree