Manager, Clinical Operations, Site Management

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

📋 Description

• Conduct interviews and select candidates for the roles of CRA and In-House Clinical Research Associate (IHCRA).

• Ensure uniform onboarding processes for both permanent and contract CRAs/IHCRAs.

• Guarantee that CRAs receive thorough and timely training to execute all visit types and other billable monitoring tasks.

• Provide on-site guidance for CRAs through observation or site evaluation visits.

• Maintain regular communication and one-on-one calls with CRAs/IHCRAs to assess quality metrics, including compliance with site visit reports, source data verification metrics, trial master file readiness, expense report submissions, and project status updates.

• Oversee the quality of the assigned CRAs/IHCRAs.

• Serve as a contact point for escalating performance issues related to CRA/IHCRA within projects.

• Review timecards, including hours logged by contractors.

• Verify the accuracy of Sciforma assignments and workload distribution.

• Conduct performance evaluations, reward or discipline staff, address employee relations concerns, and find resolutions to problems.

• Develop and implement corrective and preventive actions (CAPAs) as needed; provide support to the Directors of Clinical Operations.

• Approve paid time off requests for CRA/IHCRA staff.

• Review and authorize non-billable expenses for CRA/IHCRA personnel.

⛳️ Requirements

• Bachelor’s degree with a major in biological, physical, health, pharmacy, or other related sciences, along with six years of experience in clinical research as a clinical research associate, OR

• An associate degree (unless holding a nursing degree; in which case refer to the requirement above) or equivalent education/training paired with seven years of clinical research experience as a clinical research associate, OR

• Eight years of clinical research experience as a clinical research associate or in a related role within a pharmaceutical or biotechnology company.

• Minimum of two years of management experience.

• Capacity to comprehend multiple study protocols.

• Excellent oral and written communication abilities.

• Strong organizational and planning skills.

• Good interpersonal capabilities.

• Proven problem-solving and decision-making skills.

• Exceptional attention to detail.

• Familiarity with clinical research principles and processes, including skills in data collection and editing.

• Proficiency in using Electronic Data Capture (EDC) software such as InForm and Medidata.

• In-depth knowledge of U.S. Food and Drug Administration (FDA) regulations, International Council for Harmonisation (ICH) guidelines, and the Health Insurance Portability and Accountability Act (HIPAA).

• Understanding of standard operating procedures.

• Knowledge across various therapeutic areas.

• Proficiency in Microsoft Word, Excel, and Outlook.

• Willingness to travel.

• A valid passport is required.

🏝️ Benefits

• Competitive benefits package tailored to location.

• Paid time off (PTO) available for CRA/IHCRA employees.

• An inclusive and equitable work environment.

• Transparency in compensation and pay equity.