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:

• Drive the execution of all Site Contracts and Budget negotiations and oversee the Contracts Specialists and/or SSUAs during the process of investigator site negotiation for assigned studies.
• Train Contract Specialist and/or SSUA on any fallback language agreements or investigator grant budget parameters at the project level.
• Ensure quality of all Site Contracts by reviewing and approving on request language and budget changes requested by investigator sites. Coordinate with Clinical Lead and Sponsor on management of sites’ requests for changes. Negotiate changes towards solutions with Contracts Specialists and/or SSUAs. Negotiate agreements within established parameters and escalate legal questions/issues appropriately to Line Manager, Clinical Lead, Premier’s Legal Counsel or Sponsor as required.
• Create templates as required for each new study by selecting appropriate templates and tailoring for study requirements while escalating the material deviation to responsible stakeholders (Line manager, clinical leadership, legal). Obtain client’s approval on study-specific templates and establish negotiation parameters if possible. Confirm suitability of each template with local country experts, if necessary.
• Works with Premier Regulatory Submission Leads to provide final CSA and/or budget per country/site as needed for country regulatory submissions.

What we are searching for:

• Undergraduate degree or its international equivalent in life sciences or legal studies from an accredited institution.
• At least 5 years of legal experience with contract language, budget development and negotiations, preferably clinical study related.   
• Prior team management and coordination preferred. Ability to work with internal and external customers/vendors to meet project-specific goals.
• Understand the impact site contracts, budgets and other agreements have on project execution, timelines and overall management of the site.
• Knowledge of basic requirements of contracts, non-disclosure agreements, powers of attorney and related documents.

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $80,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

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