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In assignment for a renowned client in the life sciences sector, a freelance support is sought in the area of Clinical Data Management. The main task is taking responsibility for coordinating all data management activities in clinical trials.
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- Creation and review of the Data Management Plan (DMP) and the Data Validation Plan (DVP).
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- Coordination of data collection, validation, and cleaning throughout the study lifecycle.
- Development and execution of query processes to resolve data inconsistencies with investigative sites.
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- Standards: CDISC (SDTM, ADaM), GCP (Good Clinical Practice), 21 CFR Part 11.
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- Data visualization: Tableau, Power BI.
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- Efficiency: Average time to query resolution (target: < 10 business days for critical queries).
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- Ensuring data integrity and security (cybersecurity, data protection/GDPR).
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Frontend developer to HR platform with Angular experience
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Freelance Clinical Data Manager (m/f/d)
Industries
Biotechnology
Pharmaceutical
Areas
Quality Assurance (QA)
Research and Development (R&D)
Project info
- Period02.07.2025 - 02.10.2025
- Capacityfrom 90%
- Daily rate620 - 830€
- LocationMunich, Germany
- Language
- German(Native)
- German
- Remotefrom 80%
Description
In assignment for a renowned client in the life sciences sector, a freelance support is sought in the area of Clinical Data Management. The main task is taking responsibility for coordinating all data management activities in clinical trials.
Typical responsibilities in this role:**
Creation and review of the Data Management Plan (DMP) and the Data Validation Plan (DVP).
Design and implementation of electronic case report forms (eCRFs) in EDC systems (Electronic Data Capture).
Coordination of data collection, validation, and cleaning throughout the study lifecycle.
Development and execution of query processes to resolve data inconsistencies with investigative sites.
Medical coding of adverse events (AEs) and medications (e.g., using MedDRA, WHODrug).
Conducting SAE reconciliation (matching serious adverse events).
Preparation and execution of database locks after data collection is complete.
Preparation of status reports and communication with the study team (project management, monitoring, biostatistics).
Relevant technologies, tools, or methods:**
EDC Systems: Medidata Rave, Oracle Clinical, Viedoc, Zelta, OpenClinica.
Programming/analysis tools: SAS, R, Python, SQL.
Standards: CDISC (SDTM, ADaM), GCP (Good Clinical Practice), 21 CFR Part 11.
Collaboration tools: MS Teams, Jira, Confluence.
Data visualization: Tableau, Power BI.
Typical KPIs or success metrics:**
Data quality: Query rate (number of queries per 1,000 data points) < X; data entry error rate < 1%.
Time management: Time from last patient last visit (LPLV) to database lock (target: 4–6 weeks).
Efficiency: Average time to query resolution (target: < 10 business days for critical queries).
Compliance: 100% adherence to DMP-defined milestones and processes.
Protocol adherence: Rate of protocol deviations related to data management < 5%.
Key challenges, risks, or specifics:**
Managing increasing volumes and sources of data (e.g., wearables, ePROs).
Ensuring data integrity and security (cybersecurity, data protection/GDPR).
Complexity due to mid-study changes (protocol amendments) and their impact on the database.
Ensuring consistent data quality across multiple global investigative sites.
Shortage of qualified specialists and high demands for onboarding in study-specific systems.
Concrete deliverables:**
Finalized and approved Data Management Plan (DMP).
Live and validated study database (EDC system).
Regular data cleaning reports and status updates.
Clean, quality-assured, and analysis-ready database.
Final locked study database with complete audit trail.
Archived project documentation after study close-out.
Requirements
Must-haves:**
Degree in Life Sciences, (bio-)informatics, statistics, or equivalent qualification.
Several years of hands-on experience in clinical data management in the pharmaceutical industry or at a CRO.
Solid knowledge of regulatory requirements (ICH-GCP, 21 CFR Part 11) and industry standards (CDISC).
Experience with at least one common EDC system (e.g., Medidata Rave, Oracle Clinical).
Nice-to-haves:**
Certification as a Certified Clinical Data Manager (CCDM®) from the Society for Clinical Data Management (SCDM).
Programming skills in SAS, R, or SQL.
Experience leading data management subprojects.
Personal qualities and mindset:**
Exceptional attention to detail and precision.
Strong analytical and problem-solving skills.
Excellent communication and teamwork skills for collaborating with interdisciplinary study teams.
High degree of autonomy, organizational talent, and sense of responsibility.
Ability to work accurately under pressure and set priorities.
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