Key Accountabilities:
Site Contract Lead Tasks:
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Oversee the site contracting process for clinical trials, ensuring that contracts are executed in a timely and effective manner.
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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.
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Developing all Project set up documents for contracting, including but not limited to: Clinical Trial Agreement templates, Fallback languages, Site Contract Plan, etc.
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Advise on investigator grant budgets/parameters in collaboration with a global team of Grant Strategy and Investigator fees.
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Ensuring that all terms and conditions are clear, effectively aligned with the overall project needs.
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Participate on KOMs to provide feedback on preferable contracting strategies and beneficial tactics.
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Oversee project specific Site Contracts team, providing leadership, guidance, and necessary project/client specific training to the team members.
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Develop and implement best practices for site contract management, including specific processes, procedures, and tools.
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May support the department through shared knowledge and other defined pathways, as well as deescalate issues.
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Conscientiously control the budget from a site contracting aspect, ensuring that costs are tracked, managed, and communicated timely and effectively.
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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.
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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).
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Build and maintain strong working relationships with external and internal stakeholders and facilitate alignment of relevant parties aiming at expedited contract execution.
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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.
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Monitor data accuracy and completeness.
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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:
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Possess strong diplomacy, leadership skills and excellent organizational ability.
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Excellent interpersonal, verbal, and written communication skills.
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Ability to motivate both individuals and a team with strong influencing skills.
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Ability to successfully work in a “virtual” multicultural team environment and across different time zones different time zones.
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Must have strong analytical skills with the ability to create or interpret legal language and budgets.
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Demonstrate thought leadership and innovation.
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Maintain grace under pressure while displaying a high level of professionalism.
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Align internal and external resources to achieve objectives.
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Demonstrated attention to detail.
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Comprehend and interpret contract language.
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Identify problems independently and execute solutions.
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Quickly comprehend desired end-result, goal or objective and act to accomplish.
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Demonstrated effective decision-making.
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Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint.
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Polished presentation skills.
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Strong negotiation skills and ability to manage complex contracts.
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Good project management skills and ability to manage multiple projects simultaneously.
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Relationship-building skills.
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Familiarity with relevant legal framework and regulations related to site contracting within the CRO industry.
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Experience with relevant software tools and technologies used in site contracting, such as eTMF and contract management systems.
Knowledge and Experience:
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Senior Site Contract Lead requires 5+ years of experience in site contracting or combination with a related field within the CRO industry.
Education:
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Bachelor's degree in a related field (e.g., law, economics, business, social sciences), equivalent training or industry experience.
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