Site Contracts Lead

Premier Research; United States; On-site; USD 120,000 - 150,000; Full time

Job summary

Premier Research is seeking a Site Contracts Lead to join our Regulatory Submissions and Contracts team in the United States. You will oversee investigator site contracts across studies, review language and budgets with country experts, and negotiate changes with Sponsors.

You’ll establish study templates, coordinate with Regulatory Submission Managers, and escalate complex legal issues as needed. Strong negotiation and regulatory knowledge are essential.

Qualifications

• Undergrad degree in legal studies or life sciences. Law degree preferred.

Responsibilities

• Oversee site contracts with country experts during investigator site negotiations.
• Review and advise on language and budget changes; liaise with Sponsor.
• Create templates for new studies and tailor to study requirements.
• Coordinate with Regulatory Submission Managers for country-specific CTAs/budgets.
• Escalate legal questions to Line Manager or Sponsor as needed.
• Identify and mitigate contract-related risks and conflicts.
• Participate in project meetings; liaise with clients and other functions.
• Ensure contractual agreements are clear, fair, and legally binding.

Skills

Contract negotiation

Budget development

Legal analysis

Verbal & written communication

Cross-border regulatory knowledge

Education

Undergrad degree in legal studies or life sciences

Law degree preferred

Job description

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.

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.

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