Clinical Research Data
Resume:
YURY ROYTMAN
Philadelphia, PA 19115
*********@***.***
Objective: To obtain a position as a clinical QC auditor, clinical data coordinator/analyst, clinical data reviewer, adverse reactions specialist, drug safety associate with a leading pharmaceutical company or CRO.
Education: 1975-1980 School of Pharmacy, Zaporozhye, Ukraine.
Bachelor of Science in Pharmacy.
Professional Training and Certification: Clinical Research Associate Education and Training Program.
Fundamentals of Clinical Research.
May 2000, Medical Research Management
Training Program including the following topics:
Drug Research and Development, FDA Regulations [IND, NDA, IRB Informed Consent], GCP/ICH, Consolidated Guidelines, Data Management, Protocol and Information Consent Writing, FDA and GCP Audits.
Certifications: Clinical Research Professional and GCP/ICH Guidelines for Monitoring.
Experienced with Oracle Clinical, ClinTrial, ARGUS 7.0.7 databases, MedDRA 20.0, Who Drug coding systems, and EDC system.
Professional Experience:
October 2015- October 2017, Pfizer, Peapack, NJ
Drug Safety Data Management Specialist (Contract Assignment)
Entered applicable information into the global safety database for initial or follow up cases received via paper, fax or email. Booked -in, quality checked and initially assessed cases from suppliers sending cases to DSS via paper, email or fax.
Accepted E2B cases received through the Argus Electronic Submissions Module (ESM) from European Health Authorities on behalf of Pharmaceutical Country Offices that are not online with Argus and other submitters as necessary.
Monitored electronic mailboxes and Argus ESM to ensure timely acceptance of Adverse Event (AE) Reports. Performed data entry into databases as needed.
Ensured proper coding of events and drugs for cases to ensure correct forwarding to the relevant Therapeutic Area Teams and Licensing Group, and performed the peer cases review. Completed post acceptance activities and Migration cases.
Jan 2010- May 2019 Verree Pharmacy, Philadelphia, PA
Pharmacy-Technician:
Received written prescriptions.
Keyed prescription data, typed prescription labels.
Prepared manual records for the signature or initials of the pharmacist.
Maintained computerized database of patients profiles.
Counted dosage units. Placed dosage units into containers.
Got and returned drugs to stock.
Affixed prescriptions labels to containers.
July 2008- January 2010 Wyeth (Collegeville, PA)
Database Specialist (Regulatory Affairs) (Contract Assignment):
Performed the data receipt process & notified senders of discrepancies
Executed Data processes in accordance with GPC Guidelines
Paid strict attention to detail to ensure documentation appears accurate and process steps followed
Scanned documents using Kofax Recognition Software
Confirmed that product properties were available in Global Product Registrations (GPR) and PDM; initiated update process when appropriate
Imported documents into EDMS; promoted documents to the Final cabinet after quality check
Linked documents to PDM
Conducted appropriate quality checks to ensure completeness and accuracy of scans, EDMS importation and PDM linking
Acted as a contact/liaison with Affiliate or Plant personnel regarding quality check and verification activities
Acted as contact/liaison with translation vendor, as needed
Additional tasks to support GPC as designated by the GPC Regional Data Factory Coordinator, Regional Hub Lead and GPC Program Management Office (PMO).
July 2007-December 2007, GlaxoSmithKline (Collegeville, PA)
Clinical Data Scientist (Contract Assignment)
Reviewed standard format data displays in protocol and CRF’s to insure consistency in data capture.
Maintained protocol documentation including study file.
Reviewed data collected for patient, including lab data.
Updated the database as a result of the answered DCR’s, case listings or edit reports.
Reviewed patient profile listings.
Reviewed data transfers and edit output.
Knowledge in clinical data and ability recognize errors. Experience working with oncology projects.
September 2006- June 2007 Icon Clinical Research (North Wales, PA)
Drug Safety Associate (Contract Assignment):
Responsible for reporting Adverse Events and other medically related information to pharmaceutical company sponsor/FDA, including writing safety narratives, maintaining adverse event database, tracking logs and paper files, safety review of patient clinical data and data entry of Adverse Event case reports.
Entered initial and follow-up information for individual adverse event case onto
Global Drug Safety database, using data interpretation, coding and writing skills,
to ensure consistency of case entry and high data quality standards. Knowledge of standard
medical and drug vocabularies including MedDRA.
Identified and requested appropriate follow-up information on cases.
Performed all activities within the required timeframes to insure regulatory compliance.
Ensured compliance with global and local procedural documents and implementation of Clinical Drug Safety objectives, policies, processes and procedures.
January 2006- August 2006 AstraZeneca (Wilmington, DE)
Clinical Data Coordinator (Contract Assignment):
Reviewed protocol against Case Report Forms(CRF’s), reported findings to senior staff to assure consistency and quality of study data.
Reviewed Case Report Forms generated from clinical trials for completeness and accuracy, using edits and CRF listings.
Updated the database as a result of the answered DCR’s, case listings or edits reports.
Reviewed dual key comparison results and resolved discrepancies against CRF source.
Logged and tracked queries, and ensured query resolution.
Reviewed data transfers.
Entered changes and updated study database based on query resolution.
Reviewed data listings to identify data quality issues.
Participated in the quality control review of data.
Reviewed regulatory documents using DIRM database.
Participated in archiving study documents.
Experience working with oncology projects.
January 2004-December 2004 Discovery Lab (Doylestown, PA)
Clinical Data Coordinator (Contract Assignment):
Conducted database audits by comparing CRF (Case Report Forms) data to SAS reports to ensure completeness, accuracy and compliance with company and/or client’s SOPs
Cross-checked various related CRF data fields such as patient’s medical history, previous/concomitant medications and adverse events (AEs) for consistency.
Reviewed CRF data against Data Clarification Requests (DCR) forms to ensure that all appropriate changes are made in Clintrial database and SAS reports.
Reported discrepancies by writing detailed Issue Log Sheets.
Informed GCP Specialist and/or Director of any CDM (Clinical Data Management) process related issues that would impact or delay completion of database audits.
Provided in-process and spot check QC (quality control) reviews of Issue and Tracking Logs.
Ensured that QC review of database and resulting Issue Log Sheets are completed within specified timelines.
Maintained and updated Issue and Tracking Logs.
Assisted in training new team members.
January 2002-December 2002 Omnicare Clinical Research (King of Prussia, PA)
Clinical Data QC Auditor (Contract Assignment):
Participated in activities that ensured quality, consistency and integration of study data through to Clean File.
Conducted activities that assured data capture, data validation and QC.
Maintained continuous data inflow to ensure complete and accurate study data.
Monitored study conduct and progress, identified and resolved issues which would impact study quality or timelines.
Informed GCP Specialist and/or Director of any CDM (Clinical Data Management) process related issues that would impact or delay completion of database audits.
Ensured that QC review of database and resulting Issue Log sheets are completed with specified time lines.
December 2002- November 2006 Kings Highway Pharmacy,Brooklyn,NY
Pharmacy-Intern:
Maintained computerized database of patients profiles.
Solid knowledge of pharmacological effects of medications and common adverse reactions.
Interacted with physicians regarding medications utilization and treatment options.
Monitored, evaluated and reported adverse drug reactions to a supervisor.
Interpreted prescriptions for legal requirements, authenticity, and accuracy or drug interactions.
Documented medication dispensing and patients response with newly approved drugs.
Resolved insurance issues with managed care organizations and counseled patients.
November 2000- December 2001 Omnicare Clinical Research
Clinical Data Coordinator (Contract Assignment):
Reviewed the protocol and guidelines.
Reviewed Case Report Forms (CRFs) generated from clinical trials for completeness and accuracy using edits and CRF listings.
Generated Data Clarification Requests (DCRs) if data is incomplete, unclear or discrepant according to the Data Management Plan (DMP ).
Applied answered DCRs to the CRFs and database.
Updated the database as a result of the answered DCRs, case listings or edit reports.
Knowledge of database and data retrievals.
Attended departmental project meetings.
Personal: U.S. Citizen
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