Premier Research is looking for a Site Contracts Lead to join our Regulatory Submissions and Contracts team.
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.
The Site Contracts Lead is responsible for managing all aspects of implementing Non-Disclosure Agreements, Clinical Trial Agreements, Contract Amendments and other associated documents for assigned studies (“Site Contracts”). The Site Contracts Lead is responsible for ensuring high quality of all Site Contracts and that all documents comply with consistent standards and local legal requirements for assigned studies. The Site Contracts Lead is responsible for managing all steps of the process for initiation and completion of all Site Contracts in parallel with study start up timelines and site initiation projections. The Site Contacts Lead serves as the liaison with the client for reporting on the status and execution of all documents.
The Site Contracts Lead will negotiate the terms of all Site Contract templates with each Sponsor at the beginning of each project, and serve as liaison between the sponsors and country experts in all negotiations.
The Site Contracts Lead will assist the Manager of Site Contracts in development and maintenance of templates for CTAs, NDAs and other documents as needed and will review all such templates for compliance with local legal requirements and industry standards regularly.
- 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.
- Assists in development and implementation of new initiatives and processes in site contracts.
- 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.
- Represents Premier Research Contracts Department during internal and Sponsor Kick-Off Meetings.
- 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.
- Provides training on clinical site contractual requirements and negotiation.
- Mentors and trains junior level staff.
- Participates in corporate initiatives and actions that ensure the continued success of the company.
- Provides performance feedback on project team members for annual appraisals.
- Other activities as designated.
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
