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On behalf of a renowned client in the life sciences sector, freelance support is sought in Clinical Data Management. The main task is to be responsible for coordinating all data management activities in clinical studies.
- 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 cycle.
- Development and execution of query processes to resolve data inconsistencies with study sites.
- Medical coding of adverse events (AEs) and medications (e.g., using MedDRA, WHODrug).
- Conducting SAE reconciliation (serious adverse event reconciliation).
- Preparation and execution of database lock 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 languages/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 1000 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 working days for critical queries).
- Compliance: 100% adherence to milestones and processes defined in the DMP.
- Protocol adherence: rate of protocol deviations related to data management < 5%.
- Specific challenges, risks or considerations:**
- Managing increasing data volumes and sources (e.g., wearables, ePROs).
- Ensuring data integrity and security (cybersecurity, data protection/GDPR).
- Complexity from mid-study changes (protocol amendments) and their impact on the database.
- Ensuring consistent data quality across multiple, globally distributed study sites.
- Lack of qualified specialists and high training demands for study-specific systems.
- 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 data set ready for statistical analysis.
- Final locked study database with complete audit trail.
- Archived project documentation after study completion.
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- Typical tasks in this role:**
- Review and approval of manufacturing and batch records for drug substances and drug products.
- Final quality release of clinical trial materials for use in studies.
- Review and approval of GMP-related documents such as SOPs, validation reports, deviations, and change control requests.
- Creation and maintenance of product-specific quality agreements with internal and external partners.
- Support for production and QC departments on all GMP questions and quality topics.
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- CAPA effectiveness: reduction in repeat deviations after CAPA implementation (target: > 80%).
- Audit performance: number of critical/major findings in internal and external audits (target: 0).
- Deviation closure rate: percentage of deviations closed within the defined timeframe (target: > 90%).
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- High complexity and variability due to the development of new molecules and processes in clinical phases.
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- Ensuring product quality and patient safety under high time pressure (time-to-market).
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- Risk of supply chain interruptions for critical raw materials or services.
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- Released batches of clinical trial materials.
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- Valid quality agreements with all relevant partners.
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Service description
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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
- Period07.07.2025 - 07.10.2025
- Capacityfrom 90%
- Daily rate620 - 830€
- LocationMunich, Germany
- Language
- German(Native)
- German
- Remotefrom 80%
Description
On behalf of a renowned client in the life sciences sector, freelance support is sought in Clinical Data Management. The main task is to be responsible for coordinating all data management activities in clinical studies.
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 cycle.
Development and execution of query processes to resolve data inconsistencies with study sites.
Medical coding of adverse events (AEs) and medications (e.g., using MedDRA, WHODrug).
Conducting SAE reconciliation (serious adverse event reconciliation).
Preparation and execution of database lock 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 languages/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 1000 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 working days for critical queries).
Compliance: 100% adherence to milestones and processes defined in the DMP.
Protocol adherence: rate of protocol deviations related to data management < 5%.
Specific challenges, risks or considerations:**
Managing increasing data volumes and sources (e.g., wearables, ePROs).
Ensuring data integrity and security (cybersecurity, data protection/GDPR).
Complexity from mid-study changes (protocol amendments) and their impact on the database.
Ensuring consistent data quality across multiple, globally distributed study sites.
Lack of qualified specialists and high training demands for study-specific systems.
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 data set ready for statistical analysis.
Final locked study database with complete audit trail.
Archived project documentation after study completion.
Requirements
Must-Haves:**
Degree in life sciences, (bio)informatics, statistics or a comparable 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:**
Certified Clinical Data Manager (CCDM®) certification 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 accuracy.
Strong analytical and problem-solving skills.
Excellent communication and teamwork skills for working in interdisciplinary study teams.
High level of independence, organizational talent and sense of responsibility.
Ability to work precisely under time pressure and prioritize tasks.
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