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YOUR CONTRIBUTION

 
 
As Head of Clinical Data Management & IT (m/f/d) you will lead and enhance the clinical data management for our clinical trials and support other departments when implementing GCP compliant software-as-a-service solutions. In the developing environment with growing data integration and increasing regulatory demands, we consider Clinical Data Management as a central function to organize timely and high-quality data processing with data flows among various service providers and computerized systems. Therefore, you will fill a key role leading a team of experts to liaise with the relevant stakeholders, to supervise outsourcing, and to ensure efficient and compliant processes. This includes a close cooperation with Clinical Operations and other departments to select IT service providers and to ensure their adherence to Merz SOPs and GCP.
 
 

  • Team Leadership and Development: Lead, mentor, and develop a team of three employees and provide guidance and oversight to ensure the team’s success.

  • Data Management: Provide efficient, GCP-compliant clinical data management processes from trial initiation to database close and decommissioning. Organize transfer and filing of databases and other essential records. Develop and improve data management standards and SOPs.

  • Data Integration & Provision: Organize adequate and efficient data integration from various data sources (e.g. eCRF, eCOA, laboratory, CTMS). Provide aggregated data sets, reports, analyses, and documentation to support other functions such as centralized, on-site, and medical monitoring.

  • Service Provider Management: Define tasks to be outsourced to service providers, evaluate proposals, and ensure proper oversight of clinical data management processes and clinical databases.

  • IT Compliance: Oversee the organization and tracking of clinical IT system documentation, compliance, and oversight, in accordance with GCP regulations.

 
 
 

YOUR PROFILE

 

  • Academic degree in mathematics, statistics, data science, or IT/computer science.

  • At least 5 years of experience in clinical data management at a CRO or in pharmaceutical industry, ideally some time in a leadership position.

  • In-depth understanding of database creation, data integration and data provision.

  • Proven track record in working with data management tools and systems (eCRFs, eCOAs) and managing large clinical trials (>1000 participants).

  • Strong background in GCP, regulatory requirements, and good knowledge of medical terminology.

  • Fluency in English (written and spoken), German language skills are an advantage.

  • Team player with exceptional communication, and organizational skills.

YOUR BENEFITS

 

  • Individual career development with the purpose of improving the quality

  • Hybrid work model that allows a good work-life balance

  • Attractive location with good transport links, modern workplaces and company restaurants

  • International family business with flat hierarchies and an open, appreciative corporate culture

  • Attractive remuneration with extensive social benefits

  • Variety of employer-subsidized benefits such as WellPass, Germany ticket, Corporate Benefits and JobBike

 

Ansprechpartner

Viktoria Becker Talent Acquisition Partner