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.
Main activities are:
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.
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 / Master / PhD degree, preferably in a life science or mathematics-related area (e.g., computer sciences, biomedical sciences, Bio-engineering, epidemiology, pharmaceutical sciences, biology, …)
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)
What we offer:
We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers, eco vouchers, mobile phone (data included)
We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, ...)
Side activities will be organised regularly, to achieve a close collaboration within our team
We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
We contribute to a number of charities & support the research and / or the patients in our industry.