[Hiring] Clinical Contracts Analyst @Teleflex

Role Description

The Clinical Contracts Analyst will develop and negotiate contracts and budgets associated with clinical trials, ensure contracts comply with regulations, manage the lifecycle of contracts, and process clinical trial payments.

Principal Responsibilities

• Facilitate negotiation, execution, and ongoing revisions of clinical study contracts based on substantial knowledge of financial/fair market value, regulatory, and clinical requirements while demonstrating clinical knowledge. Recommend new/or revised language for contract templates.
• Function as the primary internal and external contact for contracts and payments.
• Assure compliance with existing agreements and analyze the need for contract amendments or renewals, and make recommendations, and/or negotiate changes to terms and conditions.
• Facilitate and direct internal legal review of contract language as appropriate.
• Maintain contract negotiation correspondence and agreements in accordance with procedures.
• Monitor changes to regulatory and legal requirements affecting clinical study contracts and reimbursement practices, in coordination with Legal and Regulatory.
• Provide proper escalation of contractual and payment issues and actively engage with management to provide recommendations for mitigation.
• Manage the clinical compensation process, database, and related reporting, including issuance of payments for investigator fees, IRB oversight, and other reimbursable costs for clinical trials.
• Manage contractual and financial information in clinical trial databases with a high degree of accuracy.
• Provide data management, analytics, reporting, and business intelligence support for clinical trials.
• Track timelines and ensure contract and compensation requirements are met in coordination with project team expectations.
• Develop a study compensation agreement template with support from project managers and management and obtain necessary approvals.
• Ensure consistency with the study protocol, clinical contract template, informed consent language, and compensation agreement.
• Collaborate with project team members on the development and testing of study payment programming.
• Interface with Finance and Accounts Payable as needed on payment inquiries.
• Regularly communicate contract and/or compensation agreement negotiation and execution status to the project team and clinical management.
• Develop and/or negotiate investigator-initiated research contracts, data use agreements, third-party vendor clinical research contracts, and clinical consulting agreements upon request.
• Perform other duties as assigned.
• Identify opportunities for process improvement in collaboration with cross-functional teams; present and implement process improvement plans to management and/or key stakeholders.

Qualifications

• BS/BA in a related field or equivalent experience.
• Experience in clinical research and related regulatory requirements.
• Minimum of five years’ experience in contract negotiation/administration and financial tracking/analysis against contracts.
• Clinical contract work experience from pharmaceutical, medical device, healthcare, or Contract Research Organizations (preferred).
• Experience with contractual agreements, including master services agreements (MSAs), statements of work (SOWs), data use agreements (DUA), non-disclosure agreements (NDAs), and amendments.

Requirements

• Understanding of regulatory requirements (e.g., CFR, GCP) and documents.
• Moderate knowledge of the clinical research process, medical terminology, and healthcare compliance and privacy regulations pertaining to legal studies (e.g., HIPAA and Sunshine Act).
• Proven expertise in Microsoft Office Suite, including Word, PowerPoint, Access, Excel, and SharePoint, and electronic data capture.
• Basic understanding of relational databases, including query design, file manipulation, and table structure.
• Ability to work in a team environment and represent the organization on specific projects.
• Advanced written and verbal communication skills and interpersonal relationship skills.
• Proven problem-solving, organizational, analytical, and critical thinking skills.
• Ability to work independently, prioritize, and work within a matrix team environment is essential.

Benefits

• Medical, prescription drug, dental, and vision insurance.
• Flexible spending accounts.
• Participation in a 401(k) savings plan.
• Various paid time off benefits, such as PTO, short- and long-term disability, and parental leave.