About Celyad

We bring breakthrough pioneering therapies to patient with life threatening diseases

Celyad is a biopharmaceutical clinical-stage company, specialized in the development and engineering of CAR-T therapies. Our ambition is to develop a unique platform to offer new treatment options to cancer patients, addressing multiple targets, optimizing the signaling domain, and weaponizing the T-Cell.

Celyad unites passionate people who keep on pushing the boundaries of innovation, leveraging unique scientific know-how from Research & Development to Phase III clinical trials, as well as a strong expertise in cell manufacturing and logistics.

Based in Europe and in the U.S., Celyad offers a stimulating working environment built around teams of highly motivated experts. Our Company surrounds itself with the best industrial and academic partners to explore the full potential of our technological platform.

At Celyad, we know that every second counts for the patients and their families, and that is what drives us in our work every single day. Ready to take up this challenge?

Celyad is looking for an enthusiastic: 

Clinical Data Associate (M/F)

The Clinical Data Associate is responsible for managing all aspects of the global clinical study data management process from start-up to database lock and regulatory submission support. The Clinical Data Associate will ensure clean and valid clinical study data for delivery to biostatistics. This position coordinates activities with the Contract Research Organization (CRO), other external vendors, database programming and trial operations to define and implement data management requirements.  

Role & Responsibilities

  • Regularly reviews and queries clinical trial data and reviews for trends/signals.  Suggest queries and report trends to the internal teams and CROs
  • Manage the complete EDC system development process with each CRO from initial set-up through database lock including; UAT Plan and testing of clinical study databases along with review/approval of edit check specifications and manual data listings as required
  • Supervise, review and manage, the surveillance of CRO and third-party vendor performance activities regarding the quality and timeliness of the deliverables and ensure database is ready for lock. Provide justification for and perform direct negotiations with CRO for data management and statistical sections; Observe and recommend opportunities for improvement and optimization
  • Works closely with CRO database builders during programming of EDC databases and edit checks
  • Review and approve all essential data management documents with CROs; including CRF specifications, eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans (detailing complete data management processes throughout clinical studies), Data Review Guidelines, Data Entry Guidelines, Data Transfer specifications and laboratory data handling
  • Provides feedback on draft protocols, CSRs and other documents as required
  • Helps design listings in support of clinical and medical review of data
  • Ensure clinical databases and external data files are designed in a consistent format to produce dataset that are conducive to analysis. Coordinate deliverables with data management and statistical vendors such: SC briefing documents, IND Annuals, DSUR, safety listings. Coordinate data cuts/transfers and conduct data reviews
  • Review and approve all statistical assumptions and provide input on deliverables: SAP, TFLs
  • Maintain all data management internal files, ensuring preparedness for regulatory inspections
  • Ability to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, vendor specifications
  • Functional Lead on project and program teams including multi-disciplinary interactions by participating in/leading project meetings to ensure clear overview of progress, risks and mitigation strategies by all participants for all data management related deliverables
  • Responsible for tracking individual project tasks and overall data management timelines
  • Review and approve data management and statistical sections of contracts, change orders and invoices
  • Develop and maintain data management SOP’s and related control documentation

Qualifications & Experience

  • Bachelor’s degree or equivalent in a health-related field preferred
  • 5+ years experience in clinical data management in the pharmaceutical/biotechnology industry covering early phase oncology trials
  • Experience with clinical data collection, cleaning and analysis
  • Working knowledge of at least one EDC system, preferably Medidata Rave
  • Knowledge of medical terminology
  • Ability to work in cross-functional team-oriented environments
  • Understanding of ICH and regulatory environment as it pertains to data management
  • Experience with SDTM/C-DASH is desirable
  • Experience managing third party vendors
  • Excellent written, verbal and organizational skills
  • Must be detail-oriented

Skills & Competencies

  • Outstanding written and verbal communication skills, including excellent attention to detail
  • Good team player, used to working in multifunctional environments. The ability to build and maintain excellent working relations at all levels with a high regard for honesty, integrity, and professional ethics
  • The ability to take the initiative and work autonomously on selected topics
  • Proven ability to manage complex projects and to organize heavy workloads effectively. Flexibility to re-prioritize workload to meet changing timelines, adaptability

For more information about this position or about the Company, please contact us by email at  job@celyad.com

Celyad respects and recognizes your privacy. The information that you provide to us will be used solely for the purposes of processing your application. This information may be shared with Celyad’s affiliates and partners. For more information about how Celyad uses your data, see the terms of use.

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