Clinical Data Manager

OPIS s.r.l. • ,

1d

About The Position

As a Senior 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.

Requirements

• Bachelor's degree in a scientific or related discipline.
• At least 7 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.

Responsibilities

• 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.

Benefits

• competitive salary
• additional benefits
• opportunity to grow your career within a collaborative and expanding international organisation

What This Job Offers

• Job Type: Full-time
• Career Level: Senior