JOB SUMMARY:

The Clinical and Medical Affairs Administrator will play an integral role within the Clinical and Medical Affairs department. This role focuses on the contract execution and budgetary oversight for the CA/MA team. 

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

• Act as the point of contact to execute Medical and Clinical Affairs vendor/clinical research site contracts, coordinating with Legal and relevant Clinical and Medical Affairs Managers as appropriate.
• Manage vendor & site payments trackers across Clinical and Medical Affairs projects; initiate and maintain vendor agreements as well as NDAs and SOWs.
• Execute IIS contracts working with investigators and their parent institutions, coordinate with MA IIS lead to confirm achievement of milestones and ensure payouts and timely closeouts of projects.
• Perform Fair Market Valuation (FMV) to ensure vendor contracts are executed appropriately.
• Maintains clinical research budgets and tracks expenditure at the project level.
• Manages all aspects of clinical trial site payments, including coordinating and processing payments to sites according to      established timelines and guidelines.
• Develop and maintain strong relationships with clinical trial sites to ensure timely and accurate site payments and disbursements.
• Work closely with cross-functional teams to gather and analyze data related to site payments, and provide regular updates and      reports to management.
• Liaise with Finance to forecast and manage budgets across Clinical and Medical affairs projects including timely processing of vendor invoices in SAP for payment. 
• Responsible for the maintenance of records for all contracts/agreements.
• Prepare RFPs for vendor selection with input from relevant managers in CA/MA.
• Ensure Sunshine Act reporting compliance working with Legal on all activities across the CA/MA team.
• Support the maintenance of the relevant sections of the Clinical and Medical Affairs SharePoint site that pertain to contracts, invoicing, and budgets.
• Perform all work in compliance with the company policy and within the guidelines of New World Medical Inc.’s Quality System.
• Ensure adherence to organizational standard operating procedures, good clinical practice (GCP) and FDA regulations and other regulatory and industry guidelines and standards. 

KNOWLEDGE, SKILLS AND ABILITIES:

• Extremely organized
• Team player
• Excellent interpersonal communication and problem-solving skills
• Ability to show good judgment, initiative, professionalism, and resourcefulness
• Able to recommend and implement processes that can improve administrative efficiency across Clinical and Medical Affairs 
• Capable of multitasking and prioritizing tasks with minimal to no supervision, managing several projects simultaneously
• Able to work independently and cross-functionally, i.e. with finance, legal, and R&D departments

EDUCATION AND EXPERIENCE:

• Bachelor’s degree
• Minimum 2-3 years of related experience in contracting, handling budgets, etc. 
• Knowledge of clinical trials and medical affairs 
• Experience working in FDA-regulated industry (general) highly preferred
• Familiar with SAP, Datarails or similar programs required 
• Well-versed in the use MS-Office applications (e.g., Outlook, Excel, PowerPoint, Word, SharePoint, Teams, etc.) and Adobe PDF effectively

PHYSICAL REQUIREMENTS:

• Must be able to operate a computer and other office productivity equipment, such as a computer printer, computer keyboard, calculator, etc. 
• Requires considerable sitting, typing and viewing of computer screen for extended periods of time
• Occasionally move about inside the office and travel to and from office buildings to access office equipment, attend meetings and/or events. This may include standing, bending and walking. 
• Ability to listen and speak with employees and vendors, investigators, and internal stakeholders. Must be able to exchange accurate information in these situations. 

This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.