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.
Establish process and procedures for overall site contract management in the organization.
Review, draft and negotiate a variety of agreements including site contracts, 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
Requirements
Graduate, postgraduate, 4-year college degree
Equivalent experience ideally in a scientific or healthcare discipline
Previous CRO experience
5+ years Oncology experience
Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements 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