Senior Data Management Specialist
2 semanas atrás
As a Clinical Data Manager II, you will play a pivotal role in ensuring that data captured in multiple clinical trials is collected, managed, and reported clearly, accurately and securely. This position offers an exciting opportunity to work on studies end-to-end, from protocol review to database lock.
Key Responsibilities:
- Monitor study status (e.g., enrollment, CRFs monitored/approved) on an ongoing basis
- Present deliverables to clients, gather feedback and propose solutions
- Provide regular data status reports to the project team
- Oversee work of the Clinical Data Coordinator as required (quality, timeliness)
- Ensure that timelines and deliverables meet sponsor and protocol requirements
- Conduct reconciliation between external data and data in the EDC system to ensure consistency
Study Setup - Technical
- Develop the data management plan (DMP)
- Build a study-specific clinical database using the EDC system:
- Design the electronic case report form (eCRF)
- Coordinate the validation and testing (UAT) of the clinical database
- Support the study team with the development of external systems capturing clinical data
User Training and Support
- Develop eCRF completion guidelines and other training material
- Conducts training for site users/monitors on the clinical database
- Activate/de-activate new users in the clinical database in response to requests from the project manager
- Respond to users requiring assistance with the EDC system
Database Close/Lock
- Generate data listings and reports needed for data review in preparation for database close/lock
- Ensure that data management documentation is complete and up to date in the trial master file (TMF)
- Archive the clinical database and related documents
Requirements:
Education:
- B.Sc. or M.Sc. in a related field of study
Experience:
- 10 years of clinical data management experience in the pharmaceutical industry or in a CRO environment
- 5 years of experience as a lead data manager
- Extensive experience working with EDC systems (experience with Medrio and Medidata Rave preferred)
Knowledge and Skills:
- 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 of applicable regulations, including Good Clinical Practices (GCP), ICH Guidelines
- Good understanding of CDISC SDTM/CDASH standards
- Knowledge of MedDRA and WHODrug dictionaries, an asset
Benefits:
- Flexible work schedule
- Home-based position
- Ongoing learning and development opportunities
About Us:
A global leader in dermatology research and clinical trials, we offer a collaborative and innovative work environment, with attractive advancement opportunities.
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