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AI Summary
Oversee database development, data cleaning, and database lock activities while ensuring compliance with CDISC and regulatory standards. Act as the primary contact for sponsors and mentor junior team members to improve data management processes.
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.
What You'll Do:
We offer a competitive salary, additional benefits, and the opportunity to grow your career within a collaborative and expanding international organisation.
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.
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.
- 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.
We offer a competitive salary, additional benefits, and the opportunity to grow your career within a collaborative and expanding international organisation.
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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