Clinical Data Manager II/Senior Clinical Data Manager (Clinical Research)
ΠΡΡΡ & Π‘ΠΎΠΏΡΠΎΠ²ΠΎΠ΄
ΠΠ»Ρ ΠΌΡΡΡΠ° Ρ ΡΡΠΎΠΉ Π²Π°ΠΊΠ°Π½ΡΠΈΠ΅ΠΉ Π½ΡΠΆΠ΅Π½ Plus
ΠΠΏΠΈΡΠ°Π½ΠΈΠ΅ Π²Π°ΠΊΠ°Π½ΡΠΈΠΈ
TL;DR
Clinical Data Manager II/Senior Clinical Data Manager (Clinical Research): Managing all aspects of the clinical trial data management process from study start-up to post-database lock with an accent on database development, testing, and quality control. Focus on overseeing project data entry, developing CRF specifications, conducting UAT, and ensuring regulatory compliance.
Location: Remote; candidates must be based in the UK, Poland, Hungary, Romania, Serbia, or Slovakia
Company
is a global organization specializing in clinical research services for pharmaceutical and biotech companies.
What you will do
- Manage the full clinical trial data management lifecycle from study start-up to post-database lock.
- Act as the primary Data Management contact for assigned projects, ensuring continuity and timely delivery.
- Oversee database development, including creating CRF specifications and conducting User Acceptance Testing (UAT).
- Coordinate with third-party EDC vendors and sponsors to manage timelines and deliverables.
- Perform medical coding, SAE/AE reconciliation, and run study-level status and metric reporting.
- Develop and maintain Standard Operating Procedures (SOPs) and Trial Master File documentation.
Requirements
- Must be based in the UK, Poland, Hungary, Romania, Serbia, or Slovakia.
- 8+ years of experience as a Senior CDM or 5+ years as a CDM II within a CRO, Pharmaceutical, or Biotech company.
- Professional proficiency in English (both written and oral).
- Experience with clinical database management systems and database migrations.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Bachelors degree or a combination of equivalent related experience.
Nice to have
- Experience in Oncology.
- Knowledge of SAS programming and quality control of SAS programs.
Culture & Benefits
- Remote work flexibility within specified European countries.
- Opportunity to work within a global team.
- Commitment to equal opportunity employment and diversity.
ΠΡΠ΄ΡΡΠ΅ ΠΎΡΡΠΎΡΠΎΠΆΠ½Ρ: Π΅ΡΠ»ΠΈ ΡΠ°Π±ΠΎΡΠΎΠ΄Π°ΡΠ΅Π»Ρ ΠΏΡΠΎΡΠΈΡ Π²ΠΎΠΉΡΠΈ Π² ΠΈΡ ΡΠΈΡΡΠ΅ΠΌΡ, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΡ iCloud/Google, ΠΏΡΠΈΡΠ»Π°ΡΡ ΠΊΠΎΠ΄/ΠΏΠ°ΡΠΎΠ»Ρ, Π·Π°ΠΏΡΡΡΠΈΡΡ ΠΊΠΎΠ΄/ΠΠ, Π½Π΅ Π΄Π΅Π»Π°ΠΉΡΠ΅ ΡΡΠΎΠ³ΠΎ - ΡΡΠΎ ΠΌΠΎΡΠ΅Π½Π½ΠΈΠΊΠΈ. ΠΠ±ΡΠ·Π°ΡΠ΅Π»ΡΠ½ΠΎ ΠΆΠΌΠΈΡΠ΅ "ΠΠΎΠΆΠ°Π»ΠΎΠ²Π°ΡΡΡΡ" ΠΈΠ»ΠΈ ΠΏΠΈΡΠΈΡΠ΅ Π² ΠΏΠΎΠ΄Π΄Π΅ΡΠΆΠΊΡ. ΠΠΎΠ΄ΡΠΎΠ±Π½Π΅Π΅ Π² Π³Π°ΠΉΠ΄Π΅ β