Thomas Borowski Email & Phone Number

Princeton, NJ

Reviewed clinical data, generated and resolved queries and reconciled outstanding data issues to support the delivery of clean data to client.Part of data review team which reviewed clinical data for 11,000 patient cardiovascular study. This included standard data management processes to identify erroneous, missing, incomplete using Metadata RAVE.Generated.

(engagement At Novartis Pharma, E. Hanover, N.J)

• Lead Data Manager Managed Clinical Data Management project activities at study level, which ensured efficient coordination between study and data management teams.
• As liaison, acted as primary contact for all data management issues from study teams, and assured timely resolution during study set-up, conduct and close-out phases.
• Accountable for all offshore team deliverables including CRF development, edit check specs and UAT testing, and creation,/review and maintenance of CRF Completion guidelines.
• Ensured project milestones were met, according to agreed-upon timelines.
• Managed relationships between client and offshore team, by providing guidance and supervision, effectively minimizing conflict.

Bridgewater, N.J

• Led study data management activities for oncology trials in preparation for study close-out.
• Coordinated 3 database locks simultaneously, effectively meeting critical timelines and locked a total of 5 databases during the course of this assignment.
• Directed query management of all Data Review Forms (DRFs) of older multi-national legacy paper trials.
• Continually maintained Serious Adverse Event reconciliation to assure proper linearity between Global Epidemiology and Clinical databases.
• Implemented timely database and CRF updates as needed by country sites, providing quick response needed for database closures.
• Based on pre-determined scripts, conducted edit check validation testing using Oracle Clinical.

Somerville, N.J

Short term contract to assist Ethicon staff in cleaning database for database lock. Reviewed patient profiles against action steps by sites to assure medical device study was clean and accurate for upcoming BLA submission.

East Hanover, N.J

As Clinical Data Manager, coordinated data reviews of oncology patient profiles and listings to assure data consistency for sponsor studies. Provided assistance to CRO oversight for specific data-handling issues.

Rahway, N.J

Assured external laboratory data from vendor loaded correctly and safely in proper location within company electronic data capture database. Using company remediation software and INFORM, was responsible for data allocation and corrective laboratory error remediation for studies in process of finalizing.

Murray Hill, N.J

Maintained the safety and integrity of sponsor company's data for Phase II-IV EDC and paper-based clinical trials. Performed multi-panel User Acceptance Test validations on EDC study edit checks which resulted in more accurate and clear queries.

Basking Ridge, N.J

Provided Business Process development support to data managment team, which established and strengthened Integrium's coorporate SOP portfolio. Worked closely with senior data management to establish departmental SOPs and Working Practices, as part of larger corporate initiative. Additionally, provided business and strategic oversight, overseeing.

Jersey City, N.J

Responsible for leading and implementation of clinical data management activities supporting clinical Fibromyalgia trials, from study start up to database close. Directed data management reviews of Protocol amendments and assured CRF accuracy and design. Also conducted User Acceptance Testing of data entry screens to reflect protocol requirements.

Montville, N.J

Managed and assured the clinical data integrity of pivotal submission for 40 investigational sites. Reviewed data queries for completeness to assure highest level of quality, prior to release to field. Archived laboratory data and Data Clarification Forms using ClinTrial, which assured proper organization of patient laboratory data and ease of retrieval..

Piscataway, N.J

Managed, coordinated and conducted quality reviews of company's IND applications and all sections of Clinical Study Reports for internal and external contract vendors, including FDA Submissions, Briefing Packages and manuscripts. Reported directly to Vice President of Quality Operations.

New York, N.Y & Morris Plains, N.J

Managed in-house and vendor clinical imaging/scanning functions to effectively meet company quality standards. Oversaw daily scanning operations for 5 contract imaging specialists. Additionally, directed activities of Eclipse CRF Help Desk, delegating and prioritizing tasks resulting in timely triage of clinical imaging issues to appropriate line.

Summit, N.J

Conducted GCP audits of investigators, Novartis systems, and CRO's for all phases of clinical research. This included analysis of information, effective communication and documentation of GCP issues, and recommendations for corrective actions. Coordinated clinical inspection activities by interpreting regulations and policies, and communicating results to.

East Hanover, N.J

Provided critical support to Global Quality Management group analyzing processes and procedures. These included support of continuous quality improvement initiatives based on quality control and ongoing focus group discussions. Was a key member of cross-functional teams that developed quality management plans for various projects, which ensured project.

Kenilworth, N.J

Responsible for accuracy of all clinical data reported to the FDA and European Union. Utilized Inquire and reports generated by programmers to support Medical staff in maintaining accurate data. Generated patient listings/sumamries for inclusion in worldwide health registration and provided Medical Department with clear and concise reports for study.

Mba, Pharmaceutical Business Administration

Program focused on the pharmaceutical industry in specific, aligned with general MBA courses as well like Economics, Monetary & Fiscal.

Bachelors Of Science, Chemistry

Activities and Societies: Previous member of American Chemical Society

High School Diploma, General College Preparatory