Experience

Actelion (now Janssen Pulmonary Hypertension)

• Switzerland
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Trial data scientist

  • Jun 2017 - Present

  Pulmonary Arterial Hypertension (PAH) associated with Portal Hypertension phase IV, Medidata Rave, 120 patients with lock early 2018_Manage project timelines and quality by organizing the workload (daily cleaning, ongoing basis review; reconciliation, QC check, ad hoc change request)_ Develop and maintain good communications and working relationships with internal team (project data scientist, programmer, physicians, global trial lead, global drug safety, clinical operation, review matter expert) and external service provider (central lab, s-cubed ad hoc listing and DB view)_Attending study related meeting (CTT meeting, GDS SAE reconciliation, PD review, cleaning progression, Lock taskforce)_ Update study documentation, specification following DB build change request and or data review process (data management plan, data review manual, coding assignment, CCM listing, PD codelist), follow the change request process and validate the changes needed._Maintain Trial Master File (paper + electronic archival) and follow-up of related issues _Provide assistance to the study team in the scope of the position and find innovative, user-friendly solution to follow up lock process progression._Quality enhancement monitored via clear and meaningful metrics, marker. Show less

• Data Scientist

  • Jun 2016 - May 2017

  Clostridium Difficile Associated Diarrhea (CDAD) phase III, Medidata Rave, 1200 patients with dry runs and lock in early 2017_Manage project timelines and quality; determine resource needs, allocate the task to the DM team and coordinate the activities with the Trial Data Scientist_Develop and maintain good communications and working relationships with internal CDM team (3 data scientists), third party vendors (central lab and microbiology samples, ECGs) and outsourced clinical team (CPM’s and CRA’s from PPD)_Help the CDM team and the outsourced CRA’s, CPM’s to prepare for the lock by providing solutions (reports, answer questions...)_Serve as backup to the Trial Data Scientist, lead the internal meeting, attending CTT meeting and meeting with CRO_Optimization of the technical operations (ECG reconciliation, Lab reconciliation, Microbiology reconciliation), enhancement of the data quality with better follow-up and time saving_Optimization of the dry run and study drug lock process by implementing a single tracker that gather all the remaining issues to resolve (Pages status, query status, questionnaires, blank fields, sticky notes, vendor queries ect) and also contain a summary with the number of issues by patient and the lock status (ready to lock or not). _Leading Taskforces to follow the cleaning progression of DB, vendor transfers for the lock_Operational activities: Perform comprehensive data management tasks including data review, writing and resolving data clarifications; cleaning activities; data reconciliation (external data vs database); specific listings and database status. Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Data Manager

  • Apr 2014 - May 2016

  Manage delivery of projects through full data management study life-cycle (with minimal guidance). With guidance from DTL or Manager, manage project timelines and quality; determine resource needs; identify out-of-scope work. Serve as back-up for Data Operations Coordinator or Data Team Lead (with guidance). Perform comprehensive data management tasks including data review, writing and resolving data clarifications. Perform database designer activities for technologies not requiring extensive programming. Perform comprehensive quality control procedures. Independently bring project solutions to the CDM team. Solve issues through using the global issue escalation/communication plan. Consult with Standards Group for process issues; communicate ideas for process improvement. Assist in developing and implementing new technology. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team. Interact with CDM team members to negotiate timelines and responsibilities. Show less



Florida Cancer Specialists & Research Institute

• United States
• Medical Practices
• 700 & Above Employee

• Internship

  • Apr 2013 - Aug 2013

  5 months intership as data manager and clinical research associate.Palm Beach Cancer Institute part of Forida Cancer, FL USAClinical research associate5 months training – April/August 2013Research principles; policies and practices according to GCP guidelines; HIPPA/CITI training; Knowledgeable on protocols (inclusion/exclusion criteria, visit schedule, test performed, dose modification…); Screening of research subjects; Obtaining informed consent; Screening/Enrollement log editing; Regimen building; Following applicable procedure in accordance with the protocol, the GCPs and SOPs; Maintains clinical study biological samples in temperature (Freezer temperature log); CRF filling; Source documents collecting; Safety reporting to warn the physicians about the latest AE/SAE that occurred in the other study sites. Show less

• data manager/CRA intern

  • Apr 2013 - Aug 2013