Are you an experienced Data Manager motivated for a next challenge in the dynamic world of Early Development? Do you find teamplay important and want to develop further your project management skills within Data Management? Don't miss this opportunity!
The Clinical Data Manager is responsible for end-to-end quality deliverables of data management activities for clinical trial including study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. Ensure activities are completed according to agreed standards and timelines; develop and implement data management plans; serve as representative in the study team; provide comprehensive data management expertise and support to team members; coordinate cross functional teams to ensure the flawless conduct of a clinical trial from a data-flow perspective.
Provides DM leadership and expertise as a core member of the Clinical Trial Team and ensures the CTT members are consulted on study decisions related to Data Management. Liaises directly with internal customers (Clinical, Biostatistics, Safety, Quality Assurance, etc.).
In charge of the DM activities (Performing the activity on Internal studies or Performing oversight on outsourced studies)
- eCRF set-up, UATs (eCRF/Edit checks)
- Study plan/documents development/review: Data Management Plan, Data validation Specifications, eCRF completion guidelines, validation listing & reports specifications, communication plan, training slides kit for sponsor and investigators, annotated CRF, File transfer specifications (IRT, eCOA, Central lab), reconciliation plan; centralized Monitoring Plan (CMP), DM section of study documents (monitoring Plan)
- Specifications for (S)AE notification tool validation and tests performed (SAGA), safety reconciliation plan, QC plan development, specifications for data validation/review reports programming
- Organize and conduct appropriate meetings with study team (Data strategy on collection and data validation)
- Interact with external vendors (IRT, eCOA, Central Lab, Cognizant...)
- Data validation - Queries management
- Review of data reports (Patient profile, Data Validation report, Data Review (data listings), (S)AE reconciliation) and corrective action until resolution (e.g: queries)
- Third party data loading and data reconciliation
- Programming/review of deviation listings
- Retro planning for DMC, IA, database locks developed and follow-up.
- Database lock
- eTMF archiving
- Organize and conduct appropriate meetings with study team (Data review, deviation meeting, pre-lock meeting)
Manages External Vendors on data management activities and maintains a good working relationship with vendor. Performs assessment of vendor performance trends and service risks. Meets regularly with vendor representative to implement mitigation actions.
- Bachelor's degree or University degree - Preferably in a life science or mathematics-related area (e.g., computer sciences)
- Minimum 2 years of Clinical Data Management or equivalent experience in clinical trial industry, preferably including Phase 1 and Phase 2 studies
- Knowledge of Clinical Trial Development Processes
- Knowledge of ICH-GCP, Industry standards and practices
- Strong communication and interpersonal skills
- Experience with tools and systems for managing clinical studies (study progress and metric systems, eCRF databases,…)
- Experienced with managing multiple external data sources (labs, biomarker, etc.)
- Able to work independently but also in a team environment
- Demonstrated problem-solving capabilities and innovative thinking
- Proficiency in Microsoft Office
- Fluent in English (written and spoken)
- Existing right to work in Europe required
- A balanced salary package based on your capabilities and experience
Vacancy number: 19819