Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements
Work closely with Clinical Operations study team and play a key role to ensure deliverables are in alignment with defined study timelines
Review, draft and negotiate master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts
Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues
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
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
Requirements
Graduate, postgraduate, 4-year college degree
Equivalent experience ideally in a scientific or healthcare discipline
Previous CRO experience
Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements, vendor contracts and site Budget negotiations, but no less than 5 years’ experience
Experienced leading interactions with Study Teams and Sponsor
Preferred: Bachelors in law, scientific fields, business administration or equivalent degree
Preferred: Excellent organizational and communication skills and attention to detail
Preferred: Knowledgeable on setting up Contracting Plans - Guides for CTA & Budget negotiations
Preferred: Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines
Competencies: strong organizational/written communication skills, ability to multi-task, attention to detail, professionalism, discretion, proficiency in MS Office