Senior Clinical Research Associate

Job Title: Senior Clinical Research Associate (German Contractor)
Location: Germany (Remote or various cities)

Overview:
We are a full-service CRO with extensive experience in oncology. We specialize in early-phase clinical trials and aim to develop effective cancer therapies.

Responsibilities:

• Assist with project-specific materials (reports, study manuals, etc.).
• Stay updated on cancer therapy literature, clinical trial design, and Good Clinical Practice (GCP).
• Collaborate with project teams to meet regulatory objectives (contracts, budgets, etc.).
• Communicate with study sites and internal teams, providing timely updates and support.
• Assist with site initiation, including regulatory document management.
• Ensure study files are accurate and complete (e.g., CTMS, eTMF).
• Participate in site monitoring visits and identify/resolves study issues.
• Support project management with ongoing reports.
• May manage multiple studies simultaneously.

Qualifications:

• Education: Bachelor's degree in biological or human sciences or equivalent.
• Experience: Minimum 5 years as a Clinical Research Associate, including experience in oncology early-phase studies.
• Skills:
  • Knowledge of ICH Guidelines, GCP, and regulatory requirements.
  • Strong multitasking and organizational skills.
  • Excellent interpersonal, communication, and problem-solving skills.
  • Proficiency in Microsoft Office (Outlook, Word, Excel).
  • Fluent in both German and English.