Clinical Contracts Analyst

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Facilitate the negotiation, execution, and continual modification of clinical study contracts while recommending contract-template language.

• Act as the main point of contact internally and externally for contracts and payments.

• Ensure adherence to agreements and evaluate, suggest, and negotiate amendments, renewals, and modifications to terms.

• Coordinate the internal legal review process for contract language.

• Keep records of contract negotiation correspondence and agreements.

• Monitor regulatory and legal modifications that impact clinical study contracts and reimbursement practices.

• Elevate contractual and payment concerns and propose mitigation strategies to management.

• Oversee the clinical compensation process, including database management, reporting, and payments for investigator fees, IRB oversight, and other reimbursable clinical trial expenses.

• Manage contractual and financial data within clinical trial databases.

• Provide data management, analytical, reporting, and business intelligence support for clinical trials.

• Track timelines and align contract and compensation needs with project team expectations.

• Create study compensation agreement templates and secure necessary approvals.

• Ensure uniformity among study protocols, contract templates, informed consent language, and compensation agreements.

• Collaborate on the development and testing of study payment programming.

• Liaise with Finance and Accounts Payable regarding payment inquiries.

• Communicate the status of negotiations and executions to project teams and clinical management.

• Develop and negotiate contracts for investigator-initiated research, data use agreements, third-party vendor clinical research contracts, and clinical consulting agreements.

• Identify, present, and execute process improvement plans in collaboration with cross-functional teams.

• Lead and engage in the development of promotional and other materials to ensure completeness, accuracy, and compliance.

⛳️ Requirements

• Bachelor’s degree in a related field or equivalent experience.

• Experience in clinical research and associated regulatory requirements.

• A minimum of five years of experience in contract negotiation/administration and financial tracking/analysis related to contracts.

• Preferred experience in clinical contracts within the pharmaceutical, medical device, healthcare, or Contract Research Organizations.

• Familiarity with master services agreements (MSAs), statements of work (SOWs), data use agreements (DUAs), non-disclosure agreements (NDAs), and amendments.

• Understanding of regulatory requirements and documentation, including CFR and GCP.

• Moderate knowledge of clinical research processes, medical terminology, healthcare compliance, and privacy regulations such as HIPAA and the Sunshine Act.

• Proven proficiency in Microsoft Office Suite, including Word, PowerPoint, Access, Excel, SharePoint, and electronic data capture.

• Basic understanding of relational databases, including query design, file manipulation, and table structure.

• Ability to work collaboratively in a team environment and represent the organization on specific projects.

• Advanced written and verbal communication skills, along with strong interpersonal relationship abilities.

• Demonstrated problem-solving, organizational, analytical, and critical-thinking capabilities.

• Capacity to work independently, prioritize tasks, and function within a matrix team structure.

• Willingness and ability to travel approximately 20% both domestically and internationally.

🏝️ Benefits

• Medical insurance

• Prescription drug insurance

• Dental insurance

• Vision insurance

• Flexible spending accounts

• 401(k) savings plan

• Paid time off (PTO)

• Short-term disability

• Long-term disability

• Parental leave