Rheinfelden, Aargau, Switzerland
Clinical Data Project Manager 15 years of experience. MEDIDATA Certified Professional Specialties: System analyst-data manager delivering data aggregation/collection solutions from design concept to specification to database go live. CDISC standards, SDTM quality control. Data hub and varied data ingesting. Big Data approach to data flows. Clinical Trials Management, Process improvement, and KPI analysis. Project Management in global environment across multiple functional groups and time zones. Remote project management and reporting. Mentoring junior data managers. Working towards lean systems using data analysis tools, project management and performance monitoring tools.
Leads the CDM study team and maintains oversight of all build, conduct and close activities for multiple studies, ensuring fit for purpose quality. Implements study conventions, processes, knowledge sharing and best practices on assigned study(s). Leads and manages CDM study deliverables, including timelines, risks and coordination of cross-functional tasks Identifies and escalates study issues appropriately and addresses corrective action plans. Evaluates the impact of risks, and develops and implements mitigation plans at the study level.
Managing phase I (FIH) Oncology studies in Rave EDC & SAS Drug Development environment. Delivering PowerPoint, protocol-specific presentations. Responsibility include but not limited to protocol review, external vendors data transfer agreements review, DMP, DRP, and other DM related documentation writing and updating. Full cycle data base design in CDASH/SDTM standard; from initial protocol to go-live date. Managing external vendors (Lab, ECG, PK, IVRS etc), performing quality control and assurance of all vendor data. Using SAS Drug Development environment to QC metadata as well as EDC data. Overseeing all DM CRO activities. Responsible for VTMF data filing & maintaining 100% audit readiness. Serve as liaison between the vendors , sites, monitors and DM CRO . Delivering SDTM datasets to statistical programming for interim locks or interim data reviews. Reporting to upper management on study progress, timelines & overall status.
Business and reporting process improvement between internal clinical management and sponsor's clinical department. Providing training and feedback to CTMs on clinical trial management system KPIs. Overseeing data flow and adherence to KPI metrics agreed upon with sponsor using available tools: Business Objects reporting tools, Clinical Trial Management systems, Balanced Scorecard, Planview, WinSCP among others. Providing sponsor's feedback to PMs and CTMs on the state of their projects and assigned clinical sites. Reviewing and monitoring Protocol deviation process and timely completions of all clinical reviews.
Managing multiple, concurrent phase II & III studies in InForm EDC environment. Initiate process improvement initiatives by engaging other departments in discussion on this topic, actively proposing solutions and managing implementation of such improvements. Delivering PowerPoint, protocol-specific presentations & representing department at Investigators Meetings. Protocol review, external vendors data transfer agreements review, SOP writing and updating. Full cycle data base design; from initial protocol to go-live date. Managing external vendors (Lab, ECG, PK, IVRS etc), performing quality control and assurance of all vendor data. Managing relationships with vendors (ERT, Icon, PPD etc) and CROs (Quintiles, ICON). Providing protocol specific training to data managers in India, site coordinators and field monitors in USA and abroad. Developing and delivering training presentations for interim training sessions to CRAs and site coordinators. Managing work of data validation teams in India using available reporting software tools including performance dashboard for KPIs. Interacting closely with field monitors, clinical development teams as well as statistical programming and biostatisticians. Responsible for full cycle development and design of the Inform EDC database including all quality control deliverables (listings, edit checks, dynamic rules). Managing EDC development with IT partners (Cognizant, Accenture). Managing a process of identifying errors/inconsistencies and their resolution via DCFs, queries, field monitors or directly with the investigator sites, to ensure high quality of clinical data and timely database locks.