Clinical Ops Site Manager - CRA Mentoring

Worldwide; Roma; Remoto; EUR 55.000 - 75.000; Tempo pieno

Descrizione del lavoro

Worldwide Clinical Trials is seeking a Clinical Operations Site Manager/CRA leadership role in Rome, Italy. You will interview, select, and onboard CRA/IHCRA candidates and ensure timely training for site visits. You will mentor CRAs on-site, review quality metrics, and escalate performance issues as needed.

Travel is required; strong knowledge of FDA regulations and ICH guidelines is essential. You will manage time cards, CAPAs, and PTO approvals while collaborating with Directors to optimize

Competenze

• Ability to understand multiple study protocols.
• Excellent oral and written communication skills.
• Strong planning and organizational abilities.
• Good interpersonal skills and problem solving.
• Knowledge of FDA regulations, ICH Guidelines, and HIPAA.

Mansioni

• Interviewing and selecting CRA/IHCRA candidates and onboading.
• Train CRAs for site visits and other activities.
• Provide on-site mentoring through observation or site visits.
• Maintain regular communications and 1:1s to review quality metrics.
• Escalate CRA/IHCRA performance issues on projects.
• Review Time Cards and approve contractor hours.
• Review Sciforma assignments and workload.
• Conduct performance appraisals and address employee relations.
• Write and conduct CAPAs; support Directors of Clinical Operations.
• Approve CRA/IHCRA PTO requests.
• Review and approve non-billable expenses.

Conoscenze

FDA regulations

ICH Guidelines

HIPAA

EDC software

InForm

Medidata

Sciforma

Word

Excel

Outlook

Communication

Organizational skills

Formazione

Four-year college curriculum – life sciences

Two-year college curriculum (or equivalent)

Eight years of clinical research experience

Strumenti

InForm

Medidata

Sciforma

Word

Excel

Outlook

Descrizione del lavoro

Worldwide Clinical Trials is seeking a Clinical Operations Site Manager/CRA leadership role in Rome, Italy. You will interview, select, and onboard CRA/IHCRA candidates and ensure timely training for site visits. You will mentor CRAs on-site, review quality metrics, and escalate performance issues as needed.

Travel is required; strong knowledge of FDA regulations and ICH guidelines is essential. You will manage time cards, CAPAs, and PTO approvals while collaborating with Directors to optimize