Clinical and Medical Affairs Administrator ()

Summary:
The Clinical and Medical Affairs Administrator is a key role supporting the Clinical and Medical Affairs department, focusing on contract execution, budget oversight, and operational support. This position ensures smooth coordination between Legal, Finance, and cross-functional teams while maintaining compliance with regulatory and organizational standards.
 

Responsibilities:

• Act as the primary contact for executing Medical and Clinical Affairs vendor and clinical research site contracts, coordinating with Legal and team managers.

• Manage vendor and site payment trackers across Clinical and Medical Affairs projects, including initiating and maintaining vendor agreements, NDAs, and SOWs.

• Execute investigator-initiated study (IIS) contracts, ensuring milestones are met and timely project closeouts.

• Perform Fair Market Valuation (FMV) to ensure proper execution of vendor contracts.

• Maintain clinical research budgets and track expenditures at the project level.

• Coordinate and process clinical trial site payments according to established timelines and guidelines.

• Build and maintain strong relationships with clinical trial sites to ensure accurate and timely payments.

• Collaborate with cross-functional teams to gather and analyze data for site payments and provide regular updates to management.

• Liaise with Finance to forecast and manage budgets for Clinical and Medical Affairs projects, including processing vendor invoices in SAP.

• Maintain accurate records for all contracts and agreements.

• Prepare requests for proposals (RFPs) for vendor selection in coordination with Clinical and Medical Affairs managers.

• Ensure compliance with Sunshine Act reporting requirements by collaborating with Legal.

• Support the organization and maintenance of relevant sections of the Clinical and Medical Affairs SharePoint site.

• Adhere to company policies, good clinical practice (GCP), FDA regulations, and other industry standards.
   

Requirements:

• Bachelor’s degree.

• 2-3 years of experience in contracting, budget management, or related fields.

• Knowledge of clinical trials and medical affairs.

• Experience in FDA-regulated industries is preferred.

• Familiarity with SAP, Datarails, or similar tools is required.

• Proficient in MS Office applications (Outlook, Excel, PowerPoint, Word, SharePoint, Teams) and Adobe PDF.

• Excellent organizational, communication, and problem-solving skills.

• Ability to manage multiple tasks, prioritize effectively, and work both independently and cross-functionally.

• Strong judgment, professionalism, and resourcefulness.

• Experience recommending and implementing process improvements for administrative efficiency.
   

Physical Requirements:

• Ability to operate office equipment, such as a computer, printer, and calculator.

• Extended periods of sitting, typing, and viewing a computer screen.

• Occasional standing, bending, and walking to access office equipment or attend meetings/events.

• Ability to communicate effectively with employees, vendors, investigators, and internal stakeholders.

Department: Direct Clients
This is a full time position