Clinical Research Site Manager - 248674

Job Title : Site Manager

Job Description :

Contributor to the profitable management of the clinical research business, consistent with company principles, strategies, and objectives. Accountable for the overall coordination, organization, and efficient implementation of clinical trials including management of regulatory, clinical operations, and line management of Project Managers and support roles. Performs diverse managerial responsibilities requiring considerable analysis, judgment, and detailed understanding of clinical research processes.

Works closely with the Principal Investigator and Managing Partner to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and a regulatory perspective. In executing these position responsibilities, the Site Director is guided by Good Clinical Practices (GCP), International Committee on Harmonization (ICH) guidelines, and company standard operating procedures and policies.

Key Activities :

Planning and Management : Supports Managing Partner implementation of business plans for achieving the strategic and tactical goals and objectives of the line of business.

• Contributor to the business plan in collaboration with the PI and Managing Partner
• Contributor to the financial performance of the line of business.
• Enforce standardized policies, procedures, and performance metrics to ensure consistency and excellence in research operations, data management, and regulatory submissions and activities.
• Foster a culture of accountability, collaboration, and continuous learning.

Study Operations : Manages all aspects of clinical research studies and related office operations.

Subject Recruitment : Assists Managing Partner with the implementation of plans for recruiting subjects into each study.

Regulatory Oversight : Oversees regulatory activities for all studies including timelines, personnel

involved, and key activities. Responsible for delivery of regulatory activities and site level metrics. Ensures that studies are implemented in compliance with Good Clinical Practice (GCP) guidelines as promulgated by the Food and Drug Administration (FDA) and the International Conference on Harmonization (ICH).

Skills Required :