Premier Research is looking for a Senior 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.
What You'll Be Doing:
- Managing all aspects of implementing Non-Disclosure Agreements, Clinical Trial Agreements, Contract Amendments, and other associated documents for assigned studies.
- Oversight of all Site Contracts with country experts during the process of investigator site negotiation for assigned studies
- Leading the negotiation of terms of all Site Contract templates with each Sponsor at the beginning of each project and, serving as liaison between the Sponsors and country experts in all negotiations
- Assisting with the development and maintenance of templates for CTAs, NDAs, and other documents enduring compliance with local legal requirements
- Supporting quality of all Site Contracts
- Proactively identifies site contract and budget related risks and suggests solutions to resolve or mitigate
- Representing Premier Research Contracts Department during Sponsor Kick-Off meetings
- Oversees site contract related study timelines, milestones, deliverables and deadlines throughout the study.
- Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and Ads related to NDAs, CTAs, investigator grants and letters of authorization of 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.
- 5+ years of Contract Lead experience in clinical research, or related industry, including oversight of Site Contracts negotiations teams on regional / global level
- 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.
