PROFESSIONAL EXPERIENCE:

Confidential

Clinical Data Manager II

Responsibilities:

• Responsible for providing timely and professional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data and ensuring their resolutions in order that databases can be declared clean and locked according to strict performance standards.
• Review and contribute to the development of trial validation plan related documents and create/approve final CRF design, validation checks and reports necessary to assure high quality and consistent data.
• Review and contribute to the preparation of protocols, CRF's and prepare or review/contribute to operations manuals.
• Work on in-house trials for Oncology and collaborate with outsourced Study Managers.
• Organize / chair data management meetings.
• Support and assist clinical data managers, clinical data assistants for allocated trials.
• Work very closely with Contract Research Organizations (CROs) contracted to perform data management functions.
• Travel when required.
• All other duties as assigned.

Confidential . NJ-Aerotek

Lead Data Manager

Responsibilities:

• Study start-up, managed New CRO in Medidata Rave system and assisted with closeout of another trial
• Initiated and monitored the eCRF design (by CRO)
• Initiated and monitored study database design (by CRO)
• UAT testing on Electronic data Capture set-up and maintained RAVE-Medidata Version 5.6.4.
• Assisted in the preparation and completion of DMP
• Responsible for cleaning listings for assigned trial
• Set-up lab normal for all Local Labs

Confidential . Woodcliff Lakes, NJ

Senior Clinical Data Manager

Responsibilities:

• Managed all aspects of Clinical trial data review for Medical Affairs studies
• Manage (3) separate CROs for accuracy and adherence to protocol and study data
• Design Case Report forms (CRFs) and Electronic Case Report Forms (eCRFs)
• Initiated and monitored study database design (by CRO)
• Wrote DMP, DEG and SOP
• UAT testing on Electronic data Capture (set-up and maintain RAVE-Medidata Version 5.6.2., Phase forward)
• Responsible for liaising with personnel, co-promote partners and vendors to ensure consensus on company-wide quality policies and implementation of agreed up procedures
• Maintained the Metrics on Scope of Work and Out of Scope for Invoicing
• Presented at the investigator meetings and CRO study start up
• TA: Oncology Phase II/IV

Confidential Bridgewater, NJ

Senior Clinical Data Manager

Responsibilities:

• Responsible for protocol review and case report form design
• Responsible for Data management plan development, review and maintenance
• Managed Oracle database set up for validation purposes
• Performed Oracle discrepancy review and Data Clarification form generation
• Trained and supervised Clinical data Coordinators on data management procedures
• Reconciliation of SAE and AE data
• Developed data handling plans and Data entry plans
• Developed edit check conventions
• Developed annotations for data system
• Assisted CTM with Registry studies closeout and review
• Presented at Investigator meetings and CRO study start up
• TA: Oncology Phase IV

Confidential . Jersey City, NJ

Clinical Data Manager

Responsibilities:

• Liaised with Investigator, lead CRA and CRF Management Center to ensure proper data standard are adhere too
• Monitored data management quality control and insured that GCPS and SOPs were adhered too
• Performed database lock and prepared database release for statistical analysis
• Managed CROs for accuracy and adherence to the protocol and study data
• Reviewed and approved the study database set-up and associated data validation programs
• Managed CRO for accuracy and adherence to the protocol for study data set-up test data for accuracy
• TA: Endocrinology Phase: III

Confidential . Ridgefield Park, NJ

Senior Data Manager

Responsibilities:

• Lead Data manager for outsourced study within Goal Project
• Performed query management in cooperation with Investigators and Monitors
• Attended all study team meetings to assess and report Data Management progress
• Reconciliation of SAE & AE along with the central lab data and Local Lab normal
• Summarized outstanding issues with Clinical department
• Responsible for the validation of closeout data
• Reviewed and approved associated data validation programs and edit check specifications
• Completed and locked (3) studies within 2 different therapeutic areas
• TA: CNS/Oncology Phases: III/IV

Confidential Jersey City, NJ

Clinical Data Manager

Responsibilities:

• Oversaw all Data Management activities within study
• Worked with a new system Icophone - setting edits and reconciling data
• Responsible for all review and approval of CRF design and annotations
• Ensured proper incorporation of project data standards
• Developed and approved the Data Handling Plan
• Wrote Data Entry conventions
• Worked closely with Statistician, Clinical & Biometrics team leaders for project accuracy
• Performed query management in cooperation with the Investigator and Monitors
• Completed and managed all database lock activities for one of the largest studies in Confidential History
• Completed all reconciliation for SAEs and Lab transferred from outside sources
• TA: Gastroenterology Phase: III

Confidential, Parsippany, NJ

Lead Clinical Data Manager Coordinator

Responsibilities:

• Oversaw all data management activities within study
• Reviewed and approved CRF design and annotation
• Ensured proper incorporation of project data standards
• Developed and approved Data Handling Plan: wrote Data Entry conventions, Query Management and Quality Control sections
• Reviewed and approved the study database set up and associated data validation programs
• Liaised with Investigators, Lead CRA’s and CRF Management Center to ensure adherence to proper data standards
• Performed query management in cooperation with Investigator and Lead CRA
• Monitored data Management quality control and insured adherence to GCPs and SOPs
• Performed database lock and prepared database for release for statistical analysis
• Attended all study team meetings to assess and report Data Management progress
• Reconciliation of SAEs, AEs and Lab transferred data
• Instrumental in the start and finish of the drug Humira®
• TA: Immunology Phase: III

Confidential . New York, NY

Clinical Data Manager

Responsibilities:

• Managed CRO for (3) studies adherence to protocol and edit checks
• Trained and supervised Clinical Data Coordinators on data management procedures
• Level one, data entry error checks, generated DCF for various studies through an electronic system
• AR Closeout of pre-existing studies (7) completed
• AEM Reconciliation
• CRF retrieval using imaging through the PDF files
• Worked closely with Statistician Clinical team and Biometrics team leaders for project accuracy
• Responsible for auto encoding of safety data
• Performed listing reviews and corrections
• Set-up test data for accuracy
• Responsible for the validation of closeout data
• TA: Anti-Infective Phase II

Confidential

Contract Data Manager

Responsibilities:

• Coordinated with data entry personnel assigned to study
• Set-up and programmed the database for assigned projects
• Created validation and entry instructions based on protocol and edit checks
• Test database and insured consistency with case report forms
• Created listings for quality control
• Summarized outstanding issues with clinical department
• Designed Case Report Forms
• Resolved data discrepancies through written and telephone contact with Investigators and site personnel
• Worked closely with Statistician and Clinical team for project accuracy
• Managed CROs for accuracy and adherence to protocol
• Utilized WHO, COSTART, HARTS and MedDRA coding
• Major contribution in the first global filing for Novartis on Exelon®
• TA: CNS/Oncology Phases: II/III