Erwin Cristobal Email & Phone Number

• Oversaw the management of project timelines and milestones for a variety of Phase II/III Clinical Trials • Responsible for managing 11 clinical trials simultaneously • Ensured regular review of study data to ensure data meets integrity, quality, and endpoints defined by the study protocol via the statistical analysis testing (SAS), edit checks, and data integrity plans • Maintained TMF to support the audit and inspection readiness by filing/ uploading TMF documents in accordance… Show more • Oversaw the management of project timelines and milestones for a variety of Phase II/III Clinical Trials • Responsible for managing 11 clinical trials simultaneously • Ensured regular review of study data to ensure data meets integrity, quality, and endpoints defined by the study protocol via the statistical analysis testing (SAS), edit checks, and data integrity plans • Maintained TMF to support the audit and inspection readiness by filing/ uploading TMF documents in accordance with Standard Operating Procedures (SOPs)• Assisted in creation and configuration of Drug Tracking • Provided input into Standard Operating Procedures (SOPs) creation/ maintenance for all Project Management-related procedures • Liaised with client representatives to ensure timely deliverables • Developed training materials and trained study team and site staff • Managed project budgets and the financing of multiple studies • Delegated tasks to project team members and ensured all aspects of project launches are completed on time • Adhered to Standard Operating Procedures (SOPs) and local regulations of studies as per regulatory guidelines Show less

Toronto, Ontario, Canada

• Ensured adherence and compliance of studies as per regulatory guidelines • Assisted in the project management activities of clinical trial start-up, maintenance, and study close out for multiple studies• Closely monitored study timelines and milestones for a variety of Phase II and III studies • Coordinated and managed communications with key clients to ensure timely deliverables • Assisted Clinical Research Associates (CRAs) and Study Coordinators to maintain the integrity of… Show more • Ensured adherence and compliance of studies as per regulatory guidelines • Assisted in the project management activities of clinical trial start-up, maintenance, and study close out for multiple studies• Closely monitored study timelines and milestones for a variety of Phase II and III studies • Coordinated and managed communications with key clients to ensure timely deliverables • Assisted Clinical Research Associates (CRAs) and Study Coordinators to maintain the integrity of all data entered within the EDC System• Worked with Product Management and Software Engineers to implement software updates and trouble shoot software issues Show less

Toronto, Canada Area

• Closely monitored study timelines and milestones for a variety of Clinical Trials • Ensured responsive, timely communication with clients • Assisted Site personnel to maintain the integrity of all data entered within the database • Assisted in the configuration and implementation of multiple databases and clinical reports that are provided to clients

Toronto, Canada Area

• Provided professional assistance to clients with customer service and technical inquiries • Tracked and reported on call statuses, and client care reporting • Assisted in implementation of Customer Care procedures for more than 100 studies • Participated in the ongoing management and implementation of new software updates • Collaborated with the Project Management Team during initiation, maintenance and close-out of projects including training, client communications… Show more • Provided professional assistance to clients with customer service and technical inquiries • Tracked and reported on call statuses, and client care reporting • Assisted in implementation of Customer Care procedures for more than 100 studies • Participated in the ongoing management and implementation of new software updates • Collaborated with the Project Management Team during initiation, maintenance and close-out of projects including training, client communications, implementation of new/updated tools, data entry and validation Show less

Diploma, Heating, Air Conditioning, Ventilation And Refrigeration Maintenance Technology/Technician

Education record