Overview
Review, draft, negotiate, and track a variety of legal agreements, including confidentiality agreements, master confidentiality agreements, clinical study agreements, and amendments. Work closely with Clinical Operations study teams to ensure deliverables align with defined study timelines. Serve as a subject matter expert for site contract management within the department.
Responsibilities
- Establish process and procedures for overall site contract management across the organization.
- Review, draft, and negotiate a range of agreements, including:
- Master services agreements
- Site contracts
- Consulting agreements
- Vendor agreements
- Confidentiality agreements
- Other client contracts
- Escalate and resolve complex issues with clients and internal stakeholders.
- Negotiate site budgets.
- Provide guidance to business teams on operational implications of contract terms.
- Ensure adherence to company policies, procedures, and contracting standards.
- Provide updates to relevant study team members regarding the status of contract negotiations and execution.
- Establish, track, report, and manage site contract metrics.
- Coordinate agreement execution and track agreement expirations and other contractual obligations.
- Support maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to enable timely contract execution.
- Identify opportunities to improve processes and take corrective action.
- Mentor and/or ambassador new SCMs and other staff.
- Perform other tasks as assigned.
Requirements
- 4-year college degree (graduate/postgraduate degree preferred/acceptable as equivalent), ideally in a scientific or healthcare discipline.
- At least 7 years of experience drafting, reviewing, and negotiating site Clinical Trial Agreements, vendor contracts, and site budget negotiations.
- Experience leading interactions with US/European/APAC or other regions’ institutions.
- Experience leading interactions with Study Teams and Sponsor.
- Demonstrated ability to manage time-sensitive work while maintaining accuracy and attention to detail.
- Proficiency with MS Office software and computer applications.
Preferred Qualifications
- Bachelor’s degree in law, scientific fields, business administration, or equivalent.
- Excellent organizational and communication skills with strong attention to detail.
- Experience setting up Contracting Plans for CTA and budget negotiations.
- Experience participating in Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM).
- Proven success partnering with study teams and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines.
Compensation & Benefits
- Reasonable estimate of current compensation range: $110,700—$166,100 USD
- Discretionary annual bonus eligibility
- Health insurance
- Retirement savings benefits
- Life insurance and disability benefits
- Parental leave
- Paid time off for sick leave and vacation, among other benefits
Location
No location was specified in the provided job description.
Work Authorization
Candidates must be legally authorized to work in the country of employment without employer sponsorship.