Allison Bohn Email & Phone Number

Boston, Ma, Us

Leads the cross functional clinical data management study teams and coordinates clinical data management activities. Provides operational input, technical guidance, and hands on support to the study teams in the design, documentation, testing, and development of the electronic data capture (EDC) systems and the external clinical data systems. Manages deliverables and the performance of external vendors on assigned projects. Ensures study compliance with standard operating procedures (SOPs) and regulations and develops study-specific training for internal and external study team.

Dublin , Gb

Led data management activities on projects with diverse scope. Primary contact for internal and external team members regarding data management activities. Led and managed the electronic data capture (EDC) system for the study build life cycle for assigned studies, and worked with the functional service provider who programmed the database.

Morrisville, Nc, Us

Responsible for independently leading end-to-end data management activities, including but not limited to, accurate and timely database design, database set up, data cleaning and data management documentation.Participates in and manages the progress of data cleaning activities including the generation and resolution of queries and discrepancies.Creates external data transfer specifications and ensures the accurate and timely reconciliation of third party data.Liaises with the Sponsor as needed to discuss issues and provide data management updates.

Clinical Research Regulatory Specialist II for Seidman Cancer Center. Managed the clinical oncology research studies conducted by investigators. Completed regulatory documentation required to conduct clinical research with the IRB, pharmaceutical sponsor, and other internal/external agencies or committees.Coordinated and performed study specific regulatory processes across multiple complex studies of different therapeutic areas and phases including IND or IDE held investigator initiated trials.Maintained compliance with SOPs, GCP guidelines and current regulations.

Manages 4 separate rental properties of approximately 550 luxury suite apartments.

Managed and organized trial master files including electronic trial master files with high quality to achieve compliance with regulatory authorities, sponsor and internal standards for multiple clinical trials from trial start-up to trial closure.Extensive experience using EDC systems (Medidata Rave, Oracle, Inform, etc) including data input, data review, and query completion to ensure the integrity of clinical data.Created and implemented trial specific data collection tools for local and remote clinical sites.Oversaw and prepared for internal audits of clinical trial data and regulatory files for trial sponsors and regulatory authorities.

Worked as an associate scientist performing DNA purification/qualification/quantification, PCR, DNA agarose gel electrophoresis, genetic assays, and archival of genomic clinical trial samples. Worked as a medical technologist in all areas including phlebotomy, microbiology, parasitology, bacteriology, mycology, chemistry, hematology, urinalysis and coagulation.

Bachelor Of Science (Bs), Medical Technology

Certification As A Clinical Research Coordinator, Ccrc, Clinical Research Coordinator

Certification As A Medical Laboratory Scientist, Ascp (Mls), Clinical Laboratory Science/Medical Technology/Technologist

Certification As A Medical Technologist (Mt), Clinical Laboratory Science/Medical Technology/Technologist

Certification As A Clinical Laboratory Scientist (Cls), Clinical Laboratory Science/Medical Technology/Technologist