Note: The job is a remote job and is open to candidates in USA. Teleflex Incorporated is a global provider of medical technologies dedicated to improving health and quality of life. They are seeking a Clinical Contracts Analyst to develop and negotiate contracts and budgets for clinical trials, ensuring compliance with regulations and managing the lifecycle of contracts.
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
Skills
• 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
• Experience with contractual agreements, including master services agreements (MSAs), statements of work (SOWs), data use agreements (DUA), non-disclosure agreements (NDAs), and amendments
• 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
• Clinical contract work experience from pharmaceutical, medical device, healthcare, or Contract Research Organizations
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, dependent on the position offer