Site Contracts Lead – Sponsor Dedicated

• Establish, maintain and update training material for the site contracts lead team and site contract negotiators
• Serve as a subject matter expert and escalation point for global site contracting issues
• Oversee negotiation and finalization of clinical study agreements, including contractual language, terms, financial attachments and investigator grant budgets
• Provide oversight of contract and budget negotiation status and escalat…
• Advise study teams and Sponsor stakeholders on industry trends, norms, developments, risks and mitigation tactics
• Plan contract execution strategy and forecast site-specific contractual execution timelines
• Coordinate communications between study stakeholders and global site contract and budget negotiators
• Prepare site contractual templates, payment terms, study-level negotiation parameters and processes
• Build working relationships with Sponsors and internal project teams
• Identify contractual, budgetary and process risks and develop solutions
• Create and maintain document status reports and update department tools, systems and team members
• Collaborate with legal, finance and clinical operations departments on legal and budgetary issues
• Manage discussions regarding fair market value of investigator budgets and payment terms
• Identify best practices, investigate root causes and recommend solutions
• Train and mentor less experienced staff on SOPs, processes, tools and templates
• Support help desk and other issue-resolution pathways
• Lead internal training and process improvement initiatives
• Participate in business development presentations as a site contracts and investigator budget management subject matter expert
• Perform other assigned work-related duties

Requirements

• BS degree in life sciences, a health related field, or equivalent combination of education and experience
• Strong experience in a CRO/pharmaceutical industry and related clinical trial expertise (Study Coordinator, CRA, Pharmacy, Nursing, Healthcare Administration) or site start-up experience
• Thorough knowledge of applicable regulations, drug development and clinical project management procedures
• Strong presentation, documentation and interpersonal skills
• Proficient in MS Office (Word, Excel and PowerPoint), MS Project, Outlook and Internet
• Ability to handle multiple tasks to meet deadlines and deliver high quality work in a dynamic environment
• Above-average attention to detail
• Effective oral/written communication skills
• Ability to work independently to meet deadlines
• Strong leadership skills
• Ability to teach and mentor team members
• Ability to coach employees to reach performance objectives
• Strong background in issue resolution, meeting customer deliverables and driving best practices at organization or customer portfolio level
• Equivalent experience, skills, and/or education will also be considered

Core Competencies

Demonstrates expertise in clinical study agreement negotiation, contract management, and budget oversight while effectively collaborating with stakeholders and mentoring team members. Proficient in navigating regulatory requirements and industry trends to ensure successful project execution.

Highest-signal resume keywords

• Clinical Study Agreement Negotiation
• Contract Management
• Budget Oversight
• Regulatory Knowledge
• Leadership and Mentoring

Hard Skills

• Contractual Language
• Financial Attachments
• Investigator Grant Budgets
• Clinical Trial Expertise
• Project Management Procedures
• Attention to Detail
• Issue Resolution
• Best Practices Development

Soft Skills

• Interpersonal Skills
• Effective Communication
• Presentation Skills
• Team Collaboration
• Mentoring

Industry Keywords

• CRO
• Pharmaceutical Industry
• Clinical Trials
• Site Start-Up
• Healthcare Administration

Tools & Technologies

• MS Office
• MS Project
• Outlook
• Internet