Remote Clinical Ops Associate Manager: Strategic Leader

Worldwide Clinical Trials; Roma; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

Worldwide Clinical Trials is seeking an experienced Clinical Operations Site Manager (IHCRA) to join our Rome team. You will interview IHCRA candidates, ensure onboarding, and mentor staff while maintaining high-quality metrics across projects.

Collaborate with cross-functional teams, review timesheets and project status, and support CAPA processes. Travel may be required to support sites and remain compliant with FDA, ICH, and HIPAA guidelines while delivering excellence.

Competenze

• Four-year college degree in life sciences with clinical research experience.
• Strong communication, planning, and interpersonal skills.
• Experience with EDC software (InForm, Medidata).
• Knowledge of FDA regulations, ICH guidelines and HIPAA.
• Understanding of SOPs and therapeutic areas.
• Proficiency with Word, Excel and Outlook.

Mansioni

• Interview IHCRA candidates and manage onboarding.
• Train and mentor IHCRAs on processes.
• Communicate quality metrics and project status regularly.
• Escalate IHCRA performance issues on projects.
• Review Time Cards and hours billed by contractors.
• Review accuracy of Sciforma assignments and workload.
• Conduct performance appraisals and address issues.
• Write CAPAs and support Directors of Clinical Operations.
• Approve IHCRA PTO requests.
• Review IHCRAs' non-billable expenses.

Conoscenze

Study protocols

Communication skills

Planning & organization

Interpersonal skills

Problem solving

Attention to detail

Clinical research basics

EDC software

FDA regulations

ICH guidelines

HIPAA knowledge

SOPs knowledge

Therapeutic knowledge

MS Office

Formazione

Bachelor's degree in life sciences

Strumenti

InForm

Medidata

Descrizione del lavoro

Worldwide Clinical Trials is seeking an experienced Clinical Operations Site Manager (IHCRA) to join our Rome team. You will interview IHCRA candidates, ensure onboarding, and mentor staff while maintaining high-quality metrics across projects.

Collaborate with cross-functional teams, review timesheets and project status, and support CAPA processes. Travel may be required to support sites and remain compliant with FDA, ICH, and HIPAA guidelines while delivering excellence.