Clinical Contracts Analyst

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

📋 Description

• Oversee the negotiation, execution, and continuous amendments of clinical study contracts.

• Propose new or modified language for contract templates.

• Act as the main point of contact for both internal and external stakeholders regarding contracts and payments.

• Ensure compliance with agreements and assess the necessity for amendments or renewals.

• Facilitate and guide internal legal reviews of contract language.

• Maintain records of contract negotiation correspondence and agreements.

• Keep track of regulatory and legal changes that impact clinical study contracts and reimbursement practices.

• Address contractual and payment issues, providing recommendations for resolution.

• Oversee the clinical compensation process, including database management, reporting, and payments to investigators and IRBs.

• Manage contractual and financial details within clinical trial databases.

• Supply data management, analytics, reporting, and business intelligence support for clinical trials.

• Monitor timelines to ensure that contract and compensation obligations are fulfilled.

• Create study compensation agreement templates and secure necessary approvals.

• Guarantee consistency among study protocols, contract templates, informed consent documents, and compensation agreements.

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

• Liaise with Finance and Accounts Payable regarding payment inquiries.

• Update project teams and clinical management on the status of contracts and compensation agreements.

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

• Identify, propose, and implement process improvement strategies with cross-functional teams.

• Execute additional duties as assigned.

• Lead and engage in the review of promotional and other materials to ensure accuracy and completeness in the interpretation of clinical practices and data.

⛳️ Requirements

• Bachelor's degree in a relevant field or equivalent experience.

• Background in clinical research and associated regulatory requirements.

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

• Prior experience in clinical contract work within pharmaceutical, medical device, healthcare, or Contract Research Organizations (preferred).

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

• Knowledge of regulatory requirements, including CFR and GCP.

• Moderate understanding of the clinical research process, medical terminology, healthcare compliance, HIPAA, and Sunshine Act requirements.

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

• Basic knowledge of relational databases, including query design, file manipulation, and table structures.

• Capability to work within a team and represent the organization on specific projects.

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

• Proven problem-solving, organizational, analytical, and critical thinking abilities.

• Ability to work independently, prioritize tasks, and function effectively in a matrix team environment.

• Willingness to travel domestically and internationally.

🏝️ Benefits

• Medical insurance.

• Prescription drug coverage.

• Dental insurance.

• Vision insurance.

• Flexible spending accounts.

• 401(k) savings plan.

• Paid time off (PTO).

• Short- and long-term disability benefits.

• Parental leave.

• Equal opportunity employer.

• Support for accommodations for applicants with disabilities.