Clinical Data Specialist
il y a 2 jours
Location: Brussels, Belgium
Schedule: Full-time, Permanent, Office Based
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds.
TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Clinical Data Specialist to join a TOP pharmaceutical company in Belgium.
**Scope of the role**:
- Implements and maintains efficient standard content specifications for the data collection tools (eCRF and eCOA) that can be applied across all the diseases areas and therapeutic areas or that are specific to a specific therapeutic are or disease area
- Defines and maintains the standard collection metadata supporting the data flow from data collection to data delivery (SDTM). To that end the CDS is responsible for defining and maintaining the metadata supporting the CRF and consulting with the CDS responsible for data delivery metadata (SDTM) for compliance with the SDTM standard
- Configures standards to the specific needs and requirements of a Therapeutic Area, compound, or Disease Area (fit for purpose), generating the expected efficiencies through optimal adoption and reuse of standards. The CDS also supports the functions adopting the standards in the clinical trials
- Collaborating with an external service provider implementing efficient standards in the Rave eDC system (Medidata Solutions) and guaranteeing quality
**Main Job Tasks and Responsibilities**:
- Defines the specification of standard content in the data collections tools, primarily Medidata Rave, with the goal of creating efficiencies within the trials, consistency across the trials and automating the CRF build and the data flow from collection to SDTM
- Implements standard content in the collection tools compliant to the industry standards and health authority regulations, meeting best practices in computer system validation, where applicable
- Testing and Quality Control of the collection tools and therefore collaborates with the respective functions in Integrated Data Analysis and Reporting (IDAR)
- Defines and maintains the clinical data collection standards in line with the needs in clinical trials to meet additional scientific or operational requirement
- Guarantee that formal change management control and versioning of the standards is applied and adhered to
- Governs formally all the changes to standards and manages multiple versions in line with adoption needs of the clinical trials and drug development programs
- Tailors the global standards to the specific needs of Therapeutic Areas or Disease Ares, while maintaining the traceability and lineage of the metadata documents and correctly manages the lineage between global standards and the pre
- configured (tailored) standards
- Provides the necessary support to the clinical data management teams to achieve consistent adoption of standards in the studies (internally or outsourced to a CRO). To that end, the CDS pro-actively support identifying the standards supporting the trial objectives
**Education and Experience**:
- Deep expertise in Rave eDC (Medidata Solutions)
- Experience with running SAS programs, coding experience preferred.
- Expertise with CDISC standards: SDTM, CDASH and Controlled terminology is required
- Experience with SAS LSAF and Pinnacle 21 is a plus
- BS/BA degree in life sciences or computer science or equivalent by work experience
- 3 years of relevant operational experience in clinical data management and
- standards
- Relevant development experience in clinical data standards is strongly preferred
- Experience in prioritizing and managing multiple tasks simultaneously
- Outstanding written and verbal communication skills in English
**Our benefits when working in Belgium**:
- Competitive Salary
- Group and hospitalisation insurance
- Internet reimbursement
- Dedicated Line Manager
- Regular face-to-face or phone meetings with line manager
- Full annual performance review process
- Ad-hoc team events and end of year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement
**The Application Process**
Who will you be working for?
**About CROMSOURCE**
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
**Our Company Ethos**
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to devel
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