Investigator Contracts Lead I

Key Accountabilities

SCL Tasks:

• Oversee the site contracting process for clinical trials, ensuring that contracts are executed in a timely and effective manner.
• Monitor, drive, and report on site contract performance throughout the whole lifecycle, specifically metrics such as contract cycle times, contract aging time, contract quality and tracking compliance.
• Developing all Project set up documents for contracting, including but not limited to: CTA templates, Fallback languages, Site Contract Plan, etc.
• Advice on investigator grant budgets/parameters in collaboration with a global team of Grant Strategy and Investigator fees.
• Ensuring that all terms and conditions are clear, effectively aligned with the overall project needs.
• Participate on KOMs to provide feedback on preferable contracting strategies and beneficial tactics.
• Oversee project specific Site Contracts team, providing leadership, guidance, and necessary project/client specific training to the team members.
• Develop and implement best practices for site contract management, including specific processes, procedures, and tools.
• May support the department through shared knowledge and other defined pathways, as well as deescalate issues.
• Conscientiously control the budget from a site contracting aspect, ensuring that costs are tracked, managed, and communicated timely and effectively.
• Identify and mitigate risks associated with the site contracting process, including risks related to timelines, costs, effectiveness of implemented strategy, and quality. Collaborate with all relevant stakeholders until resolution.
• Maintain frequent, clear and effective communication with all stakeholders involved with or dependent upon the site contracting process, including sponsors, key internal stakeholders, vendors, collaborative CROs and sites (as applicable).
• Build and maintain strong working relationships with external and internal stakeholders, and facilitate alignment of relevant parties aiming at expedited contract execution.
• Provide necessary support to cross-functional teams including Start up, Global Clinical Operations, Investigator Payments, Business Development and Feasibility.
• Provide regular updates and reports on the site contracting process to clients, senior management and other stakeholders as needed.
• Monitor data accuracy and completeness.
• Support Project Lead with implementation of project hour forecasting for Site Contracts team to ensure accurate planning, resource allocation and budgeting throughout trial lifecycle.
  

Skills

• Possess strong diplomacy, leadership skills and excellent organizational ability.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to motivate both individuals and a team with strong influencing skills.
• Ability to successfully work in a “virtual” multicultural team environment and across different time zones different time zones.
• Must have strong analytical skills with the ability to create or interpret legal language and budgets.
• Demonstrate thought leadership and innovation.
• Maintain grace under pressure while displaying a high level of professionalism.
• Align internal and external resources to achieve objectives.
• Demonstrated attention to detail.
• Comprehend and interpret contract language.
• Identify problems independently and execute solutions.
• Quickly comprehend desired end-result, goal or objective and act to accomplish
• Demonstrated effective decision-making.
• Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint.
• Polished presentation skills.
• Strong negotiation skills and ability to manage complex contracts.
• Good project management skills and ability to manage multiple projects simultaneously.
• Relationship-building skills.
• Familiarity with relevant legal framework and regulations related to site contracting within the CRO industry.
• Experience with relevant software tools and technologies used in site contracting, such as eTMF and contract management systems.
  

Knowledge And Experience

• Site Contract Lead requires 3 to 5 years of experience in site contracting or combination with a related field within the CRO industry.
  

Education

• Bachelor's degree in a related field (e.g., law, economics, business, social sciences), equivalent training or industry experience.