Joshua Carter

• Phone: +1 416 555 0123
• Email: joshua.carter@email.com
• Location: Toronto, Canada
• LinkedIn: joshuacartercdm

Summary

Over 7 years of experience in clinical data management, specializing in leading data collection, validation, and reporting processes for Phase I-III clinical trials. Successfully implemented Electronic Data Capture (EDC) systems, contributing to a 15% reduction in data query resolution time and ensuring data integrity and regulatory compliance.

Adept at developing Data Management Plans (DMPs), performing UAT, and overseeing database lock activities. Proven ability to collaborate with cross-functional teams to streamline workflows and enhance data quality for pharmaceutical and biotech studies.

Experience

Senior Clinical Data Manager, MedTrials Research Inc. -- Toronto, Canada

Mar 2020 – present

• Managed data management activities for 8+ concurrent Phase II/III oncology and cardiovascular clinical trials, ensuring adherence to study protocols, SOPs, and regulatory guidelines (ICH-GCP, FDA 21 CFR Part 11).

• Led the development and review of Data Management Plans (DMPs), Case Report Forms (CRFs), and data validation specifications, resulting in a 10% improvement in initial data quality metrics.

• Oversaw the design, UAT, and deployment of Medidata Rave and Oracle Clinical databases, achieving database lock milestones on schedule for 95% of assigned studies.

• Mentored junior data managers and clinical data associates, enhancing team efficiency and reducing data query rates by 20% through targeted training.

Clinical Data Manager, BioPharma Solutions Canada -- Mississauga, Canada

June 2017 – Feb 2020

• Coordinated data management tasks for multiple Phase I/II clinical trials across various therapeutic areas, including CNS and infectious diseases.

• Developed and executed data validation checks, query generation, and resolution processes using Medidata Rave and Inform systems, reducing open queries by an average of 25% per cycle.

• Participated in the review of statistical analysis plans (SAPs) and generated data listings for interim and final study reports.

• Contributed to the improvement of data management SOPs, leading to enhanced departmental efficiency and compliance.

Clinical Data Associate, HealthMetrics CRO -- Toronto, Canada

Sept 2015 – May 2017

• Performed data entry, discrepancy management, and coding (MedDRA, WHODrug) for clinical trial data.

• Assisted in the user acceptance testing (UAT) of EDC systems and reviewed CRFs for completeness and accuracy.

• Generated and tracked data queries, collaborating with clinical sites to ensure timely resolution and data clean-up.

• Maintained accurate study documentation and participated in internal audits to ensure data quality and integrity.

Education

University of Toronto, B.Sc. in Biological Sciences -- Toronto, Canada

Sept 2011 – June 2015

Michener Institute of Education at UHN, Postgraduate Certificate in Clinical Research -- Toronto, Canada

Sept 2015 – Apr 2016

Skills

Clinical Data Management Systems: Medidata Rave EDC, Oracle Clinical, Inform EDC, Veeva Vault CDMS, SAS, SQL

Regulatory & Standards: ICH-GCP, FDA 21 CFR Part 11, CDISC (SDTM, ADaM), GDPR, Health Canada Regulations

Data Management Processes: DMP Development, CRF Design, UAT, Data Validation, Query Management, Coding (MedDRA, WHODrug), Database Lock, Data Review

Programming & Tools: SAS (basic programming), Microsoft Excel (advanced), JIRA, SmartSheet, SharePoint

Therapeutic Areas: Oncology, Cardiovascular, CNS, Infectious Diseases, Respiratory