Senior Site Contracts Manager - FSP

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 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
• Other tasks, as assigned.

Qualifications

Minimum Required

• 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

Preferred

• Bachelors in law, scientific fields, business administration or equivalent degree
• Excellent organizational and communication skills and attention to detail
• Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations
• Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
• Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines

Skills

Competencies

• Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
• Executes time-sensitive matters while maintaining accuracy and attention to detail.
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
• Demonstrates a high degree of professionalism, as evidenced by clear and concise written and verbal communication.