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Professional Summary
To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Enthusiastic Clinical Data Manager/Clinical Data Reviewer eager to contribute to team success through hard work, attention to detail and excellent organizational skills.
Skills
Creative Thinking
Medidata Rave
Daily Logs
Electronic Charting
Office Equipment
Data Tracking
Complex Problem-Solving
Efficiency Improvement
Discrepancy Management
Reading Comprehension
Data Cleaning
Research and Data Management
Work History
04/2020 to 09/2020Clinical Data Manager I-BioMLabcorp Drug Development | City, STATE,
Review Clinical Trial Data in accordance with Global Data Management Plans and applicable standardized data management process (Standard Operating Procedures and Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.
Run Ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification/correct to the database.
Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application.
Perform aggregate review of clinical data by patient, site and/or project to identify data trends (patient safety, compliance, etc.) and/or data inconsistencies that require further investigation
Potentially serve as a reviewer of project documents such as protocols, CRFs (eCRFs), monitoring conventions, CRF (eCRF) completion guidelines, etc.
Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
Assist in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications.
Assist in testing of data management system edit/data validation checks (diagnostics) and special listings/procedures used as tools for the data review and discrepancy management activities.
Potentially interact and collaborate with other project and specialty team members (clinical programming, CDM technical support) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
Potentially serve as client contact for project meetings and CDM status updates.
Support the training of project staff on project-specific, global, standardized data management processes.
Perform other duties as assigned by management.
Maintain contact and interact with monitors, sponsors
Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads.
09/2015 to 04/2020Clinical Research Data Coordinator IICalifornia Cancer For Research And Excellence | City, STATE,
Assist Principal Investigator (PI), Sub Investigators (Sub-I’s) and Clinical Coordinators to execute Phase I-IV research protocols.
Maintain source documentation for all data submitted, including clinic or PI/Sub-I visit chart notes, lab reports and procedure reports
Interpretation of data (including appropriate source documentation) for entry into the computerized databases.
Enter data into electronic data capture systems and submit Radiologic Scans (iMedidata, Rave, Inform, Bioclinica, Trial Master, eClinica, Oracle) to protocol specific vendors accurately and timely.
Attend to queries in a timely and efficient manner to meet deadlines.
Adhere to International Council of Harmonization Good Clinical Practice, Health Insurance Portability and Privacy Act, National Institutes of Health, and Food and Drug Administration Regulations.
Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads .
Maintain contact and interact with monitors, sponsors and auditors.
Coordinate lab kits with study nurses per protocol guidelines to ensure kit delivery to coordinate with research visits.
Lead trainer for new employees on research protocols, data management, and facility processes.
01/2003 to 08/2015Clinical Research Data Coordinator IIRocky Mountain Cancer Centers | City, STATE,
Assist Principal Investigator (PI), Sub Investigators (Sub-I’s) and Clinical Coordinators to execute Phase I-IV research protocols.
Maintain source documentation for all data submitted, including clinic or PI/Sub-I visit chart notes, lab reports and procedure reports.
Assist in conduction of subject visits as well as document adverse events and concomitant medications.
Interpretation of data (including appropriate source documentation) for entry into the computerized databases and submit Radiologic Scans (iMedidata, Rave, Inform, BioClinica, Trailmaster, e-Clinica, Oracle) to protocol specific vendors accurately and timely.
Attend to queries in a timely and efficient manner to meet deadlines.
Adhere to International Council of Harmonization Good Clinical Practice, Health Insurance Portability and Privacy Act, National Institutes of Health, and Food and Drug Administration Regulations.
Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads.
Maintain contact and interact with monitors, sponsors and auditors.
Coordinate lab kits with study nurses per protocol guidelines to ensure kit delivery to coordinate with research visits. Order and prepare kits for subject visits.
Lead trainer for newly hired employees on research protocols, data management, and facility processes.
Education
Expected in 08/1988 | Medical AssistingSkadron College, San Bernardino, CA, GPA:
Expected in 06/1985High School Diploma | Eisenhower Senior High School, Rialto, CAGPA:
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