Clinical Data Manager

As a Clinical Data Manager, you’ll work closely with Sponsors and cross-functional teams to oversee database development, data cleaning, quality control, and database lock activities, while supporting process improvements and mentoring junior team members.

What You'll Do

• Lead clinical data management activities in compliance with CDISC standards, regulatory requirements, and OPIS SOPs.
• Design, validate, and maintain eCRFs, clinical databases, and related data management documentation.
• Perform data cleaning, coding activities, SAE reconciliation, quality checks, and database lock activities.
• Act as the main point of contact for Sponsors and study teams on data management matters.
• Track study milestones, manage project deliverables, and proactively identify and escalate risks.
• Support audits, inspections, process improvements, and the development of data management standards.
• Mentor junior team members and contribute to study-specific training activities. What You Bring:
• Bachelor's degree in a scientific or related discipline.
• At least 5 years of clinical data management experience within a CRO, biotech, pharmaceutical company, or research organisation.
• Strong knowledge of CDISC standards, ICH-GCP, ISO14155, FDA 21 CFR Part 11, and clinical data management processes.
• Experience with clinical databases, eCRF systems, and data management tools.
• Excellent communication skills in English and the ability to work effectively in international teams.
• Strong organisational skills, attention to detail, and a quality-focused mindset. Compensation: Permanent employment: 30,000 - 40,000 EUR gross per annum

Who We Are: Founded in 1998 in Italy, OPIS is a full-service, science-driven CRO providing clinical trial management, biometrics, regulatory, pharmacovigilance, and medical writing services worldwide. Our experienced teams support clients through every stage of clinical development, delivering high-quality solutions across a broad range of therapeutic areas.

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