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.  

• Participates in internal and external project-related meetings as needed. 

• Interacts with clients and other functional areas as secondary project contact for contracting issues and questions.  

• 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 clinical study related. An advanced degree will be considered in lieu of a portion of industry experience. 

• At least 1 year of CRO experience 

• Ability to work with internal and external customers/vendors to meet project-specific goals.  

• 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. 

• Knowledge of ICH / GCP regulations.  

• Working knowledge of FDA Guidance Documents / EU Regulations / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures. 

• Knowledge of web-based communication tools for conferences and any other IT systems required for the job. 

• Knowledge of national/local health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site start-up activities will be carried out.   

• Excellent team player, collaborative and able to build an effective team. 

• Ability to multitask and work effectively in a fast-paced environment with changing priorities. 

• Ability to manage time and project requirements based on study deliverables. 

• Strong verbal and written communication and negotiation skills. 

• Excellent organizational and time-management skills, able to prioritize work to meet deadlines. 

• Accountable, dependable and demonstrates strong commitment to the role. 

• Is customer service focused in approach to work, both internally and externally. 

• Maintains a positive, results-orientated work environment.