Specialist, Site Contracts - Australia

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 

• Prepare country contract templates; 

• Draft and send Site Agreements or any contracts associated to sites to begin negotiations; 

• Negotiate contract(s) language and budget(s) with each assigned site to finalization / execution; 

• Review study budgets and costs pertaining to contract negotiation; 

• Perform quality check of Site Agreements or any documents associated before signature process starts; 

• If requested, provide draft/signed contract/budget to the regulatory team for submission purpose, where needed; 

• Liaise with Worldwide Legal Department, Data Privacy team, study teams, Sponsor, sites, investigators etc. 

• Facilitate contracts signature by Worldwide, when applicable; 

• Send Fully Executed Site Agreements or any document associated to: site, eTMF, payment team, Sponsor, post to internal Sharepoint, as applicable; 

• Negotiate Site Agreements Amendment language and budget with sites; 

• Create termination letter or any other type of documents related, and send to sites for signature, as applicable; 

• Maintain tracking tool with live/real-time/regular updates for functional activities; 

What you will bring to the role 

• Proficient in negotiating contract terms with clinical sites and vendors. 

• Ability to identify and address contract issues and disputes efficiently. 

• Good understanding of international and local regulatory require-ments for clinical trials (e.g., FDA, EMA, ICH-GCP). 

• Excellent verbal and written communication skills for effective interac-tion with internal stakeholders and clinical sites. 

• Solid analytical skills to review and interpret contract terms and financial data. 

• Ability to identify risks and develop mitigation strategies. 

Your experience 

• Bachelor's Degree or equivalent in business administration, finance, science or related field. 

• 1 to 3 years of experience in Clinical Research Pharmaceutical or CRO industry working with investigator/site contracts or related legal field. 

• Excellent verbal and written English and local language skills . 

• Proficiency with MS Word, Excel and Outlook.