Associate Manager, Clinical Operations Site Management

This is a fully remote position, open to applicants in Italy, +2 more countries.

📋 Description

• Conduct interviews and select candidates for CRA/IHCRA positions.

• Ensure a consistent onboarding process for both permanent and contract CRAs/IHCRAs.

• Guarantee that CRAs receive appropriate and timely training for all types of visits and other billable monitoring activities.

• Provide on-site mentorship through observation or site assessment visits.

• Establish regular communication and one-on-one calls with CRAs/IHCRAs to discuss quality metrics, compliance, TMF readiness, expenses, and project status.

• Serve as the escalation point for performance-related issues concerning CRAs/IHCRAs.

• Review time cards and approve hours billed by contractors.

• Assess Sciforma assignments for accuracy in workload.

• Conduct performance evaluations and manage employee relations issues.

• Draft and implement CAPAs as needed.

• Provide support to Directors of Clinical Operations.

• Approve PTO requests from CRAs/IHCRAs.

• Review and authorize non-billable expense claims.

⛳️ Requirements

• Ability to comprehend multiple study protocols.

• Excellent oral and written communication skills.

• Strong planning and organizational abilities.

• Good interpersonal skills.

• Demonstrated problem-solving and decision-making capabilities.

• Attention to detail.

• Understanding of clinical research principles and processes.

• Skills in data collection and editing.

• Proficiency in navigating EDC software (InForm, Medidata, etc.).

• Strong knowledge of FDA regulations, ICH Guidelines, and HIPAA.

• Familiarity with standard operating procedures.

• Knowledge of various therapeutic areas.

• Proficiency in Word, Excel, and Outlook.

• A four-year degree in biological, physical, health, pharmacy, or a related discipline with six years of clinical research experience as a clinical research associate; or a two-year degree (unless nursing-related, then refer to the previous requirement) or equivalent education/training 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 another role directly related to clinical research within a pharmaceutical or biotechnology company.

• Travel is required.

• A valid passport is necessary.

🏝️ Benefits

• Equal employment opportunities.

• A diverse and inclusive work environment.

• A supportive, team-oriented atmosphere.

• Accessible and hands-on leadership.

• Opportunities for collaboration with colleagues from various backgrounds and specialties.

• Employee PTO with the approval of CRA/IHCRA PTO requests.