Antwerp Metropolitan Area
16 years of professional experience in Clinical Data Management.
Accountable for the project management, complete oversight and timely delivery of clinical trial data and documentation according to agreed upon timelines and quality expectations Is the liaison between the trial customer, the CRO(s) and other functional partners(s) for all issues related to data for assigned trial(s) Ensures Inspection Readiness of all data management deliverables and ensures adequate archiving of data management documentation Is a member of SMT and Clinical Working Group(s) and leads the trial subteam(s)/workstream(s) for data management deliverables (e.g., eCRF design, Database Lock) Performs trial level oversight controls as described in the oversight plan, QC process and work instructions Prepares or reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency; ensures compliance with regulatory guidelines and the documentation matrix Ensures real-time inspection readiness of all IDS deliverables for the trial; Participates in Regulatory Agency and J&J internal audits as necessary Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival; ensures deliverables are on time and within budget Supports the assigned clinical working group(s) to ensure that IDS and TA trial needs and deliverables are met
Coordinating the work within the Team. Delegating the tasks – Quality Control. Project Coordination. Provide accurate, timely, and consistent review of data to study sponsors and other internal clients to support the study timelines. Responsible for testing writing and testing edit check specifications (Unit Testing/Integration Testing/User Acceptance Testing/Quality Testing) in Medidata Rave EDC/Architect. Participation and presentation in department meetings/trainings. Conducting Team meetings.
Responsible for designing, developing, testing and supporting complex software solutions / products and support services: writing and testing edit check specifications, development and testing electronic case report forms (eCRFs) for electronic data capture (EDC), creating and accessing drafts/projects, configuring forms/fields/roadmaps, discrepancy management and associated tasks related to data management of clinical trials databases. Coding with WHODrug and MedDRA coding dictionaries. Participation and presentation in department meetings/trainings. Provide accurate, timely, and consistent review of data to study sponsors and other internal clients.