Site Contracts Lead

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll Be Doing:  

• Oversight of all Site Contracts with country experts during the process of investigator site negotiation for assigned studies.  

• Support quality of all Site Contracts by reviewing and advising on request language and budget changes requested by investigator sites. Serve as liaison with Sponsor on management of sites’ requests for changes. Negotiate changes towards solutions to country experts. 

• Establish templates as required for each new study by selecting appropriate template and tailoring for study requirements. Confirm suitability with Sponsor and establish negotiation parameters if possible. Confirm suitability of each template with local country experts, if necessary. 

• Works with Premier Regulatory Submission Managers to provide final CTA and/or budget per country/site as needed for country regulatory submissions. 

• Independently communicates with Premier Regulatory Submission Manager on all contract-related items as needed per study. 

• Escalates legal questions/issues appropriately to Line Manager, Premier’s Legal Counsel or Sponsor. 

• Proactively identifies site contract and budget related risks and potential controversies or conflicts and suggests solutions to resolve or mitigate those risks/controversies.  

• Collaborates with Premier study team members, including the start-up team and Clinical Lead to ensure the client deliverables and expectations are achieved. 
• Is the liaison with the client for CTAs/NDAs between the country level experts and the client for assigned studies. 
• Participates in establishing study contract negotiation timelines at the beginning of the Study and oversees site contract related study timelines milestones, deliverables and deadlines throughout the course of the Study. 

• Liaises with internal customers to review contract or budget areas that impact final execution of site contracts.  

• Guides and helps Site Contract negotiators to successful completion of Study timelines and deadlines. 

• Ensures that Premier Research, clinical investigators, institutions and our clients have contractual agreements in place that are clear, fair and legally binding. Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to NDAs, CTAs, investigator grants, and Letters of Authorization or Powers of Attorney. 

What We Are Searching For: 

• Undergraduate degree or its international equivalent in legal studies or life sciences from an accredited institution. Law degree preferred. 
• At least 2 years of legal experience with global contract language, budget development and negotiations. Preferably gained in a CRO setting / clinical study related. An advanced degree will be considered in lieu of a portion of industry experience. 
• Knowledge of basic requirements of contracts, non-disclosure agreements, powers of attorney and related documents. 
• Knowledge of Privacy Laws and regulations pertaining to cross border transfer of data. 
• Working knowledge of FDA Guidance Documents / EU Regulations / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures. 
• Global experience is essential, ideally including prior / current experience of EU countries.

This position is offered as a contract with a duration of 6-months. Candidates should be available immediately or at very short notice and should already be set up to operate as a contractor / freelancer.

Preference is for candidates to have a full FTE available.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status