• Served as a member of the project team with primary responsibility for Clinical data review, query generation/ resolution and reconciliation activities to support the delivery of clinical data according to client quality and integrity specifications, and project timelines and productivity targets
• Development of the project Data Management Plan, including the creation of conventions and data review guidelines/ diagnostics specification; and set-up of the data management systems according to project requirements
• Served as the technical data management leader on small to moderate project with technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project timelines and budgets
- Senior Clinical Data Coordinator at Covance Clinical Development Services
- Clinical Data Manager I at PPD
- Clinical Data Coordinator at CoreLab Partners Inc
3 years at this Job
- B.S. - Administrative Systems Management
* Provide status reports, as requested, on the progress of specific clinical trials. * Managed the resolution of discrepancies and associated activities within data management utilizing InForm database system. * Incorporated changes resulting from manual review of data listings and update the EDC databases with DCF resolutions. * Ensure the quality of clinical trial data as required per protocol. * Promptly met the team's deadlines to ensure data lock. * Support and assist other Clinical Data Associates and Managers working on trials.
- Sr. Clinical Data Coordinator (contractor) at Advanced Clinical for Incyte
- Sr. Clinical Data Coordinator at Covance Inc
- Sr. Clinical Data Coordinator (contractor) at Real Staffing for Covance Inc
- FBR Reconciliation Specialist (Home Based) at DOCS Global for Merck & CO
10 months at this Job
- Bachelors Degree in Psychology - Distance Education and Training
- Associates Degree in Psychology - Distance Education and Training
Have worked on conduct stage of Oncology, Non-Small Cell Lung Cancer, Diffuse Large B-Cell Lymphoma, Rheumatoid Arthritis, Multiple Sclerosis studies
Roles and Responsibilities
• Serve as a Data Operations Coordinator (DOC) for protocols, for an operations team of four
• Lead the operations team in a specific area of a large study with guidance from the Line Manager
• Serve in the role of the back-up to a Data Operations Coordinator or a Data Team Lead
• Attend Client teleconferences and meetings and train and Mentor new project team members
• Conduct data review activities like query management, vendor data reconciliation, SAS listings review, and status reports creation
• Write to the site about ongoing clinical trial for clarifications in discrepancies in data
• Develop Data Management Plan documents
• Review and validate eCRF databases, and create and test edit specifications
- Clinical Data Coordinator at Quintiles Research (India) Pvt. Ltd
- INTERNSHIP at Biocon
4 years, 5 months at this Job
- Master of Sciences - Organic Chemistry
- Bachelor of Sciences - Botany and Zoology
• Audit documents and report errors according to company guidelines
• Conduct assigned Trainings in New Hire Orientation
• Oversee logs and programs
• Audit logs, Notes, and documentation in client charts
• Assist QA manager with implementing compliance of quality of care
• Ongoing supervision of Office clerks
• Develop annual reports
• Collect data
- Clinical Data Coordinator at Star View Teammates
- Office Assistant at Star View Teammates
- Behavioral Therapist at Prisms Behavioral Solutions
- Data entry/analyze patient information at In home, Hospice
1 year, 2 months at this Job
- Bachelors of Arts in Sociology - Sociology
Coordinated the health system's Cardiology data collection and submission to the American College of Cardiology (ACC) national registry for cardiac interventions. Benchmarked the health system's performance against other cardiology facilities across the country and prepared and presented reports and statistical analysis to various hospital and system quality committees. Collected and collated data from patient medical records and entered it into the ACC registry form. Monitored the process of data collection to ensure time frames were met. Generated reports from the registry and analyzed data to compare Health System to similar institutions related to key quality indicators. Measured patient, provider and facility characteristics, cardiac device type and adverse events. Identified quality gaps in cardiac patient care. Collaborated with Director to recommend new processes to improve cardiac patient care. Provided information to the committees regarding changes in mandates or definitions.
- Clinical Data Coordinator at Northwell Health
- Research Analyst at St. John's University
- Founding member at St. Andrew Avellino School
- Development Coordinator at Stone Trust Corporation
1 year, 11 months at this Job
- Bachelor of Science in Nursing - Nursing
• Perform all data management deliverables for assigned studies
• Define edit checks to be programmed for the study/project
• Create DMPs
• Maintenance of TMFs
- Clinical Data Coordinator at Amarex
- Clinical Data Associate at Covance Pharmaceutical Research and Development Co. Ltd
- Junior Statistical Programmer at Covance Pharmaceutical Research and Development Co. Ltd
- Intern at Zurich North America
2 months at this Job
- Bachelor's - Applied Mathematics
Responsible for leading and supporting data management activities from study startup to archiving by establishing planning that ensures that actions are in agreement with timelines and in accordance with current SOPs, guidance and standards. Served as the global data management representative on the clinical study team, interacting and collaborating with internal and external customers in delivering the end product of an analyzable database.
• Served as lead clinical data manager for one or more projects.
• Processed and reviewed the CRF and external data.
• Supported and lead the clinical data review activities associated with a project.
• Prepared and completed quality control reviews and reviewed clinical and external data for subjects enrolled in clinical research protocols based on edit specifications / data validation programs to facilitate data review.
• Performed User Acceptance Testing (UAT) on the eCRF and edit checks developed from a central source (CDISC compliant).
• Maintained data management study documentation as appropriate.
• Managed the data review and external data reconciliation process.
• Ensured study and task metrics were tracked and communicated to the project team and functional management.
• Demonstrated strong knowledge of computerized information systems and standard application software (Windows, MS Office, and MS Project).
• Understood clinical data management systems or electronic data capture software which included Oracle Clinical and Metadata Rave.
• Managed and supported outsourced data management activities from an external vendor.
• Managed external lab loading from an external vendor using client supported data loading system
• Flexibility and adaptability to ongoing changes in client processes and procedures.
- Lead Data Manager/Clinical Data Coordinator at PRA Health Sciences
- Sr. Clinical Data Manager at EDETEK, Inc
- Project Lead, Clinical Data Management at ALLERGAN
- Clinical Data Manager (contracted by Aerotek) at REGENERON PHARMACEUTICALS, INC
2 years, 7 months at this Job
- B.S. - Natural Sciences
-Supported all Clinical Data Technician (CDT) tasks as needed, including data entry, tracking and comparison of database listings to the Case Report Form (CRF) -Coordinated 10-15 clinical studies on a daily basis -Assisted in project closeout activities including archival of CRF's and study documentation -Assisted management with project status reports and meetings as requested -Identified potential problems with data and communicated to management as needed -Assisted Clinical Data Management (CDM) staff with administrative duties regarding Data Clarification Forms (DCF's) -Organized sending, receiving and tracking of DCF's for assigned projects -Entered data into the Oracle Clinical database using first/second pass data entry/verification -Tracked CRF and DCF pages and attachments in the tracking system -Quality Controlled database listings vs. source documents /CRF's under direction of Clinical Data Analyst's -Worked to departmental SOP's, guidelines and global standards and maintained data integrity to ensure consistency across all projects as appropriate -Assisted with archiving study documents -Responsible for populating databases within the Oracle Clinical system in support of clinical trial activity -Tracking and date entry of CRF's, DCF's and related pages
- Clinical Data Coordinator at Omnicare Clinical Research
- Quality Control Specialist at Southwest Student Services Corporation
- Ophthalmic Technician at Arizona's Vision
4 years at this Job
• Midas System Administrator
• Report writing for clinical analysis and data validation
• Reporting Hospital/Physician Quality to Medical Executive/Board members
• Manipulate and Analyze data to identify trends and/or opportunities for improvement
• Quality and Reporting for Credentialing
• System Administration including: testing, interface validation, (HL7), troubleshooting
- Clinical Data Coordinator at Marietta Memorial Hospital
- Financial Analyst at Diagnostics Hybrids
- Computer Consultant at Genesis HealthCare Systems
- Systems Analyst at
13 years, 2 months at this Job
- Associate - Computer System Technology
- Senior Clinical Data Coordinator at IQVIA
4 months at this Job
- Master's - Pharmacology
- Bachelor's - Pharmacy