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Investigator Contracts Lead I

Primary Location: India, Remote Additional Locations: India, Mumbai ID de la oferta R0000034957 Categoría Clinical Trials
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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.  


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