Clinical and Medical Affairs Administrator
Clinical and Medical Affairs Administrator
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1Year
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
This is a remote position.
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 crossfunctional 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 investigatorinitiated 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 crossfunctional 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
Requirements:
Bachelor s degree.
23 years of experience in contracting budget management or related fields.
Knowledge of clinical trials and medical affairs.
Experience in FDAregulated 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 problemsolving skills.
Ability to manage multiple tasks prioritize effectively and work both independently and crossfunctionally.
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.
Requirements Bachelor s degree in a scientific field (biology, chemistry, nursing, or pharmacy preferred). At least 12 years of experience in clinical trial management, including 8 years in a leadership role and 5 years of people management. Experience in biotech or pharma industries, particularly with autoimmune indications such as Irritable Bowel Disease or Ulcerative Colitis, preferred. Expert knowledge of FDA/EMEA regulations, ICH guidelines, and GCPs. Strong time management, organizational, and problem-solving skills. Proficiency in Microsoft Outlook, Word, PowerPoint, and Project. Demonstrated ability to manage and develop team members effectively.
Employment Type
Full Time
