Senior Clinical Data Manager
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Job Description
Senior Clinical Data Manager leading end-to-end clinical data management for Indero, a global dermatology and rheumatology CRO. Building EDC databases, ensuring data quality, and supporting database lock.
Responsibilities:
- Ensure data captured in multiple clinical trials is collected, managed, and reported clearly, accurately, and securely
- Lead data management activities across studies from protocol review through database lock
- Monitor study status, including enrollment and CRF monitoring/approval
- Present deliverables to clients, gather feedback, and propose solutions
- Provide regular data status reports to the project team
- Oversee Clinical Data Coordinator work for quality and timeliness
- Oversee vendors to ensure timelines and deliverables meet sponsor and protocol requirements
- Maintain the clinical database, including data review and cleaning during study conduct and database lock preparation
- Reconcile external data with EDC data, including sponsor safety databases for adverse events and serious adverse events
- Develop data management plans
- Design eCRFs and build clinical databases in the selected EDC
- Coordinate clinical database validation and user acceptance testing
- Support development of external clinical data systems such as ePRO or IWRS and document/test data transfers
- Develop eCRF completion guidelines and training materials
- Train site users and monitors on the clinical database
- Activate/deactivate database users and maintain request records
- Respond to users needing EDC assistance
- Generate data listings and reports for data review before database close/lock
- Ensure data management documentation is complete and current in the TMF
- Archive the clinical database and related documents
Requirements:
- B.Sc. or M.Sc., or in a related field of study
- 7 years of clinical data management experience in the pharmaceutical industry or in a CRO environment
- 3 years of experience as a lead data manager
- Extensive experience working with EDC systems
- Experience with Medrio and Medidata Rave preferred
- Highly organized and detail-oriented
- Project planning and time management skills
- Strong verbal and written communication skills in English
- Understanding of the drug development process and applicable regulations, including Good Clinical Practices (GCP) and ICH Guidelines
- Good understanding of CDISC SDTM/CDASH standards
- Knowledge of MedDRA and WHODrug dictionaries is an asset
- Must be legally able to work in Poland
Benefits:
- Flexible work schedule
- Permanent full-time position
- Ongoing learning and development
- Attractive advancement opportunities
- Equitable treatment and equal opportunity
- Recruitment and selection accommodations for applicants with disabilities upon request
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