This is a fully remote position, open to applicants in United States.

📋 Description

• Develops, maintains, and revises training materials for the site contracts leadership team and site contract negotiators.

• Acts as a subject matter expert within the organization, aiding in the resolution of global site contracting challenges and serving as an escalation point for internal customers seeking assistance.

• Manages the negotiation of clinical study agreements (CTAs) at the study level, facilitating the finalization and execution of CTA documents, which includes contractual language and terms, financial attachments, and investigator grant budgets in collaboration with a global team of site contract and budget negotiators.

• Provides oversight on the status of contract and budget negotiations and handles the escalation of out-of-parameter queries regarding budgetary and contractual requests to sponsor decision-makers across all regions involved in study conduct, offering consultation during such escalations as necessary.

• Advises study teams and Sponsor stakeholders on industry trends, standards, and emerging developments related to site contract and budget negotiations. Offers consultation on potential risks and strategies for mitigating negotiation issues linked to overall study start-up requirements.

• Serves as the primary subject matter expert for all CTA elements in assigned studies for both internal and sponsor stakeholders, guiding them on issue resolution within the context of those studies. May seek additional support from internal resources when needed.

• Strategizes contract execution for assigned studies, including accurately forecasting site-specific contractual execution timelines, and collaborates with internal study team stakeholders to ensure that the CTA strategy aligns with overall study start-up plans and expectations. Manages the expectations of both internal and sponsor study teams regarding global CTA negotiations for assigned studies.

• Facilitates communication between study team stakeholders and the global team of site-facing site contract and budget negotiators, including consolidating all status updates for regular team meetings. Participates in ongoing study calls to ensure effective communication as necessary.

• Works closely with internal stakeholders and sponsors to develop site contractual templates, incorporating payment terms and study-level negotiation parameters and processes that adhere to Company standards to facilitate successful contract and budget negotiations.

• Fosters strong working relationships and collaboration with sponsors to ensure site contractual templates align with the global strategy established for the program.

• Identifies potential operational risks related to site contracts and investigator budgetary documents or processes, proactively working to implement solutions. Builds strong relationships with customers and internal project teams, escalating deviations to senior management and effectively resolving issues with Quality Assurance.

• Creates and maintains document status reports, regularly updating departmental tools and systems while ensuring proper documentation is upheld.

• Collaborates with internal and external legal, finance, and clinical operations departments, providing clear communication and explanations regarding legal and budgetary matters.

• Oversees discussions at the site and study levels with internal and sponsor team stakeholders regarding fair market value of investigator budgets and payment terms in line with corporate and industry standards during negotiations with sites.

• Identifies best practices, investigates root causes of fundamental project issues, and recommends effective solutions.

• Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs), processes, tools, and templates, ensuring the quality of teamwork outputs.

• May assist the business unit and organization via help desk support and other designated channels to resolve and de-escalate issues.

• May take the initiative to lead internal team training and/or process improvement projects.

• Participates in business development presentations as a subject matter expert in site contract and investigator budget management within the organization.

• Performs additional work-related tasks as assigned.

⛳️ Requirements