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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

  • Period
    18.08.2025 - 18.11.2025
  • Capacity
    from 90%
  • Daily rate
    620 - 830€
  • Location
    Munich, Germany
  • Language
    • German
      (Native)
  • Remote
    from 80%

Description

On behalf of a renowned client in the life sciences sector, we are seeking freelance support in Clinical Data Management. The main responsibility is coordinating all data management activities in clinical trials.

  • Typical responsibilities in this role:**

  • Creating and reviewing the Data Management Plan (DMP) and the Data Validation Plan (DVP).

  • Designing and implementing electronic case report forms (eCRFs) in EDC systems (Electronic Data Capture).

  • Coordinating data collection, validation, and cleaning throughout the study lifecycle.

  • Developing and executing query processes to resolve data inconsistencies with study sites.

  • Medical coding of adverse events (AEs) and medications (e.g., using MedDRA, WHODrug).

  • Performing SAE reconciliation (alignment of serious adverse events).

  • Preparing and executing the database lock after data collection is complete.

  • Producing status reports and communicating 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 (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 resolve queries (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%.

  • Key challenges, risks, or specifics:**

  • Managing growing 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.

  • Maintaining consistent data quality across global study sites.

  • Shortage of qualified professionals and steep learning curve for 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 database ready for statistical analysis.

  • Final locked study database with a complete audit trail.

  • Archived project documentation after study completion.

Requirements

  • Must-haves:**

  • Degree in life sciences, (bio)informatics, statistics, or a related field.

  • Several years of hands-on clinical data management experience 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 attributes 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 set priorities.