Well-qualified Clinical Data Analyst, successful at building and maintaining secure, accurate and efficient data collection systems in different stages of clinical trial. Hardworking and pragmatic with strong attention to detail and methodical approach. Prepared to offer my 8 years of experience to fast-paced position with room for advancement.
Therapeutic Summary
Central Nervous System: Alzheimer’s Phase III (3years) Dermatology: Acne Phase II (3years), Bacteria Skin Infectious Phase I (1years) Infectious Disease: HIV/AIDS Phase I (3years), Leprosy Phase II (2years)
Oncology: Leukemia Phase I (2years), Hepatocellular Carcinoma Phase II (5years) Orthopedics :Low Back Pain (Phase II) 3years Cardiovascular: Spinal Cord (Phase I) 1year
Skills
Experience with various clinical databases (e.g., Medidata Rave, Oracle Clinical, SAS) and key technologies (e.g., EDC, Laboratories, Imaging, IVRS/IWRS)
Data analytics
Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines
Knowledge of CDISC standards and regulatory reporting and filing requirements required
Experience in leading and motivating team of direct staff
Proficiency in MS Word, Excel, Outlook, and PowerPoint, Project, SAS programming preferred
Ability to Multitask under pressure.
Broad knowledge of drug development and effective clinical data management practices.
Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook, and EDC systems.
Ability to handle variety of clinical research tasks.
Excellent organizational and communication skills.
Professional use of English language; both written and oral.
Prolific experience using IXRS system
Excellent verbal and communication skills
Ability to deal effectively with sponsors and internal customers
Experience in Core Data Management activities (e.g., Data Management Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries)
Over 7 years relevant data management experience
Work History
07/2013 to Current
Clinical Data Manager I, II & Senior CDMDuke University – Zebulon, NC,
IVD 3, Reviews CRFs, data listings, and database to ensure all captured data follow rules outlined by protocol and data management plan
Generates relevant queries to appropriate personnel (investigational sites, vendors, Clinical Research Associates (CRAs), client representatives) to resolve data error identified during every aspect of data management process
Reviews responses to queries for appropriateness, resolves any discrepancies, and modifies database as required or occasioned by event
Reconciles third party data with Clinical Data Management System (CDMS) data
Tracks and monitors CRFs as processed through Data Management department
Interaction with Project Manager continuously throughout the course of study, when needed
Coordinates and acts as point of contact for all data operations responsibilities related to data management when designated as the Data Management Lead for the project team
Preparation of all data needed for data management plans (DMP), data entry guidelines, data management reports and other documents required for preparing and completing databases
Relevant Reviews of draft protocols and CRFs for potential data collection and representation, database structure or data entry problems, financial status and provides feedback to project team as at when due
On ground to train and support newly hired associate data coordinators or data coordinators
All other projects as assigned and/or any functions as agreed upon with sponsor at the onset of project and in compliance with sponsor Standard Operating Procedures
Trains on, and follows, sponsor’s Standard Operating Procedures as applicable.
03/2011 to 07/2013
Clinical Research CoordinatorAlphanumeric Systems – Waltham, MA,
Reviews CRFs, data listings, and database to ensure all captured data follow rules outlined by protocol and data management plan
Generated paper and electronic queries to appropriate internal or external personnel (investigational sites, vendors, Clinical Research Associates (CRAs), client representatives) to resolve problematic data identified during every aspect of data management process
Reviewed responses to queries for appropriateness, resolves any discrepancies, and modifies database accordingly
Reconciled third party data with Clinical Data Management System (CDMS) data
Tracked CRFs as processed through Data Management department
Interacted with Project Manager or designee on continual basis throughout course of study, when applicable
Coordinated and acted as point of contact for all data operations responsibilities related to data management when designated as Data Management Lead for project team
Prepared data management plans (DMP), data entry guidelines, data management reports and other documents required for preparing and completing databases, when requested
Reviewed draft protocols and CRFs for potential data collection and representation, database structure or data entry problems, financial status and provides feedback to project team, when requested
Mentored newly hired associate data coordinators or data coordinators
All other projects as assigned and/or any functions as agreed upon with sponsor at beginning of project and in compliance with sponsor Standard Operating Procedures
Trained on, and follows, sponsor’s Standard Operating Procedures as applicable
Worked with IXRS systems such as Bracket
03/2009 to 02/2011
Laboratory TechnicianLarbCorps – City, STATE,
Coordinated work of other Clinical Data Management staff assigned to project
Review Study Protocol
Developed CRF or review of sponsor generated CRFs
Defined and programmed edit checks
Was Responsible to prepare, finalize and archive all related DM documentation
Developed Data Management Plan and Data Management Report
Developed Data Validation Plan (including definition of edit checks)
Developed Data Entry Instructions/ eCRF completion guidelines
Coordinated validation of database, edit checks and trial and site settings
Performed CRF handling including logging, tracking, and sorting
Supported CRAs in study related questions
Performed Data cleaning and query handling
Ensured completion of Quality Control task for finalization and transfer of study database and related documents to sponsors
Coordinated SDTM mapping with senior programmer when needed
Carried out all tasks related to database closure
Provided CDs with study documentation to sites (patient data, audit trail and closed queries)
Provided metrics and status updates to senior management and project leadership and sponsors
Trained both internal and external Clinical Study Teams
Represented TFS Data Management in sponsor and investigator meetings
Was Responsible to escalate any issues on projects or need for potential SOP deviations
Actively contributed to organization and development of processes to enhance work at company
Provided input into proposals which include Data Management and attend Bid Defense meetings face-to-face or via WebEx.
Education
Expected in
Bachelors: System Applications - , GPA:
Expected in
Microsoft Office: PowerPoint, Excel, Word & Outlook: - , GPA:
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Resume Overview
School Attended
Job Titles Held:
Clinical Data Manager I, II & Senior CDM
Clinical Research Coordinator
Laboratory Technician
Degrees
Bachelors
Microsoft Office: PowerPoint, Excel, Word & Outlook