[Hiring] Site Contracts Lead @Premier Research

Role 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.

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.

• Responsible for managing all aspects of implementing Non-Disclosure Agreements, Clinical Trial Agreements, Contract Amendments, and other associated documents for assigned studies (“Site Contracts”).
• Ensure high quality of all Site Contracts and compliance with consistent standards and local legal requirements.
• Manage all steps of the process for initiation and completion of all Site Contracts in parallel with study start-up timelines and site initiation projections.
• Serve as the liaison with the client for reporting on the status and execution of all documents.
• Negotiate the terms of all Site Contract templates with each Sponsor at the beginning of each project.
• Assist the Manager of Site Contracts in development and maintenance of templates for CTAs, NDAs, and other documents.
• Review all 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.
• Work with Premier Regulatory Submission Managers to provide final CTA and/or budget per country/site as needed for country regulatory submissions.
• Independently communicate with Premier Regulatory Submission Manager on all contract-related items as needed per study.
• Escalate legal questions/issues appropriately to Line Manager, Premier’s Legal Counsel, or Sponsor.
• Proactively identify site contract and budget-related risks and potential controversies or conflicts and suggest solutions to resolve or mitigate those risks/controversies.
• Participate in internal and external project-related meetings as needed.
• Assist in development and implementation of new initiatives and processes in site contracts.
• Interact with clients and other functional areas as secondary project contact for contracting issues and questions.
• Collaborate with Premier study team members, including the start-up team and Clinical Lead to ensure client deliverables and expectations are achieved.
• Represent Premier Research Contracts Department during internal and Sponsor Kick-Off Meetings.
• Participate in establishing study contract negotiation timelines at the beginning of the Study and oversee site contract-related study timelines milestones, deliverables, and deadlines throughout the course of the Study.
• Liaise with internal customers to review contract or budget areas that impact final execution of site contracts.
• Guide and help Site Contract negotiators to successful completion of Study timelines and deadlines.
• Ensure that Premier Research, clinical investigators, institutions, and our clients have contractual agreements in place that are clear, fair, and legally binding.
• Review and advise on Regulatory and Clinical Operations SOPs, WGs, and ADs related to NDAs, CTAs, investigator grants, and Letters of Authorization or Powers of Attorney.
• Provide training on clinical site contractual requirements and negotiation.
• Mentor and train junior level staff.
• Participate in corporate initiatives and actions that ensure the continued success of the company.
• Provide performance feedback on project team members for annual appraisals.
• Other activities as designated.

Qualifications

• Experience in contract management and negotiation.
• Strong understanding of regulatory requirements and industry standards.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively in a team environment.
• Detail-oriented with strong organizational skills.

Requirements

• Bachelor's degree in a relevant field.
• Proven experience in a similar role.
• Knowledge of clinical trial processes and regulations.
• Ability to manage multiple projects simultaneously.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health and wellness benefits.
• Opportunities for professional development and growth.
• Flexible work arrangements.

Company Description

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.