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Senior Specialist, Site Contracts - Spain

Role overview

Summary

This role focuses on managing site contracts within Worldwide Clinical Trials' Site Contract department. You will collaborate with various stakeholders to negotiate and finalize contracts, ensuring compliance with regulatory requirements while contributing to the overall efficiency of clinical research operations.

Qualifications

  • 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
  • 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)
  • Proficiency with MS Word, Excel and Outlook

Responsibilities

  • Act as a Subject Matter Expert (SME) on Clinical Trial Agreement processes at country and site level
  • Prepare, negotiate and finalize site contracts and budgets
  • Manage the Investigator Budget and act as a key liaison for contract related communications
  • Review and finalize Clinical Trial Agreements and/or any document associated including site budget, for completeness and accuracy

Key facts

Hard skills

Other skills

  • Leadership
  • Collaboration
  • Communication
  • Problem Solving
  • Teamwork

About the company

Worldwide Clinical Trials logo

Worldwide Clinical Trials

  • Clinical Research (CRO)
  • Large
  • 1,001–5,000
About Worldwide Clinical Trials  Worldwide Clinical Trials is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new treatments. Our capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by our team members who bring their expertise and a collaborative, personalized approach to each clinical program. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers. Our talented team of 3,000+ professionals spans 60+ countries, and embraces a culture of diversity, equity, inclusion, and belonging (DEI&B). We are united in cause with our customers to improve the lives of patients through new, innovative therapies. For more information on Worldwide, visit www.Worldwide.com.

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Job description

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 onLinkedIn.


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