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Worldwide Clinical Trials

Senior Specialist, Site Contracts - Spain

Posted 3 days ago
2-5 years experience
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AI Summary

The Senior Specialist will act as a subject matter expert to prepare, negotiate, and finalize clinical trial agreements and investigator budgets. They will also collaborate with internal and external stakeholders to resolve negotiation issues and ensure process improvements.

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world. 


With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research. 


What the Site Contract department does at Worldwide 


Site Contracting is an essential function within any CRO, and our seasoned team spans decades of experience within the industry and possesses robust legal experience as well. The department is responsible for reviewing, analyzing, and drafting clinical research site contracts, investigator contracts and other project-related contracts. Our global team is familiar with the specific laws for the countries and sites we occupy. We negotiate and finalize clinical trial contracts and services contracts with the Worldwide Legal Department, study teams, Sponsors, investigators, and/or clinical sites. 


What you will do 

  • Act as a Subject Matter Expert (SME) on Clinical Trial Agreement processes at country and site level 
  • Preparation, negotiation and finalization of site contracts and budgets 
  • Manage the Investigator Budget and act as a key liason for contract related communications  
  • Resolve negotiation issues and escalating risks, drive process for improvements, contribute to SOP develoment and keep templates updated  
  • Liaising and collaborating with Worldwide stakeholders as well as external stakeholders (such as sites, investigators etc.) 
  • Review and finalize Clinical Trial Agreements and/or any document associated including site budget, for completeness and accuracy 

 

What you will bring to the role 

  • Mastery in negotiating complex contract terms with clinical sites and vendors 
  • In-depth understanding of international and local regulatory requirements for clinical trials (e.g., FDA, EMA, ICH-GCP). 
  • Ability to explain complex contract terms clearly and concisely 
  • Leadership skills to guide and support junior contract specialists 
  • Ability to collaborate effectively with cross-functional teams, including but not limited to legal, finance, data protection and clinical operations. 

 

Your experience 

  • 3- 4 years of experience as a Site Contracts Specialist or minimum 5 years Site Contract experience in Clinical Research Pharmaceutical or CRO industry 
  • Bachelor's Degree or equivalent in business administration, finance, law, science or related field 
  • Proficiency with MS Word, Excel and Outlook 
  • Knowledge and understanding of ICH and GCP Guidelines, as well as local country legislation in the sphere of clinical trials and local regulatory requirements. 
  • Adept knowledge of biopharmaceutical/CRO industry and applicable local regulatory requirements 

Discover the Difference


We love knowing that someone is going to have a better life because of the work we do.  Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.


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