SUMMARY:

Over thirteen years of research and business development, training, quality control, and data management, education and operational planning in domestic/international academic and corporate settings. Expertise includes corporate leadership, personnel, process design and implementation, contract negotiation, product development and supervision.

PROFESSIONAL EXPERIENCE:

Clinical Data Manager

Confidential

Responsibilities:

• Assist Sr. Clinical Data Manager with User Acceptance Testing
• Review of Protocols and design eCRFs according to Protocol specifications
• Assist with creating documented processes for testing new clinical trials
• Provide comments and feedback on changes or updates to the clinical database
• Provide guidance on regulated documents such as UAT plan, Data Validations, and Annotations
• Assist with data review and data clean-up
• Assist with training sites on EDC processes

Manager Clinical Data Management

Confidential

Responsibilities:

• Managed clinical data personnel to include performance, training and development and developed staffing strategies to ensure business targets were met
• Ensured that information systems are sufficient and up - to-date to meet clinical research time line target and that responsibilities were met
• Monitored and applied directives issued by government agencies such as FDA, ICH.
• Managed all external contractors, laboratories and contract research organizations for data management activities
• Ensured that all SOP s and guidelines related to data management are written and maintained
• Assisted with the development and of relevant budget, including timelines and resources
• Assisted with the evaluation of new technology maintenance for innovative solutions for the clinical data management function

Other activities included:

• Performed study start up, initiated and attended WebEx (conference calls across multiple time zones) to discuss timelines, Protocol review and part of the approving team Reviewed and approved Data Management Plans (which included: Coding, Data Entry, EDC Guidelines, and Safety Management Procedures) Created electronic CRFs and reviewed for updates and set as company standards Assisted with the first build of EDC-based study in Medidata Rave Created DVS files (Data Validation Specifications) for each study and performed UAT (User Acceptance Testing) and approved to production Performed Quality Assurance on each patient case file Acted as lead in Serious Adverse Event Reconciliation meetings Performed close out and database lock for studies

CD&O Data Support

Confidential

Responsibilities:

• Performed 1st and 2nd pass entry of Case Report Forms (CRFs) in Oracle Clinical database
• Performed 1st and 2nd pass entry of Data Clarification Forms (DCFs)
• Performed quality checks on critical data points and made necessary changes
• Assisted Clinical Data Manager(s) on managing the discrepancy database

PV Data Coordinator

Responsibilities:

• Takeda Pharmaceuticals Entered individual case safety reports (ICSR) in ARIS - g database. This includes complex medical data such as lab data, medical history, and diseases for post-marketing and clinical cases
• Entered Foreign cases for post-marketing and clinical and occasionally manually entered Expectedness/Listedness of each adverse events reported
• Monitored all Legal, Postmarketing, and Clinical cases thru the PV mailbox for registration and case processing
• Monitored and processed world-wide case reports from the affiliates and co-development partners
• Performed reconciliation of all electronic source documents received thru the PV Inbox
• Assisted with legal clean-up and archiving
• Assisted with team meetings

Safety Data/Document Specialist

Confidential

Responsibilities:

• Registered cases into Global Safety Database and performed systematic review of the Global Safety Database to ensure that duplicate case entry does not occur
• Created and labeled adverse event case files
• Performed data entry of adverse events
• Verified data against source documents and performed Quality Check of cases
• Assisted with the writing of case narratives
• Assisted with the coding of adverse events, drug indications, lab tests, medical history terms and cause of death as appropriate per case
• Developed and maintained expert knowledge of the Global Safety database
• Collaborated with other GPV staff concerning adverse events and other safety - related issues
• Supported case report distribution and submission
• Performed database reconciliations
• Provided input into and assistance with improving the efficiency and function of the data management functions
• Designed and enhanced standard department document formats
• Interfaced with other Baxter functions in regards to data clarification and reconciliations
• Developed focus and expertise in the assigned primary therapeutic area, a backup therapeutic area, and provided other support as necessary
• Took initiative to recognize, prioritize and escalate potential safety/compliance issues
• Participated on project teams and committees, as assigned

Clinical Data Manager

Responsibilities:

• Advanced Clinical,
• Followed Standard Operating Procedures (SOPs)
• Followed Good Clinical Management Practices (GCMP)
• Understand 21 - CRF Part 11 Guidelines and CDISC
• Managed multiple clinical trials from Phases I-IV in the following therapeutic areas:
• Oncology (Glioblastoma, Glioblastoma Phase IV) Rheumatology o Pediatric Ophthalmology Ophthalmology (Macular Edema) Women s Health (Dysmenorrhea, Endometriosis)
• Performed Data Management Review (in order):
• Read and interpreted Study Protocol Prepared draft of Data Processing Plan (DPP)/Data Management Procedures (DMP) and submitted for team and sponsor approval Prepared draft of CRF Completion Guidelines and submitted for team and sponsor approval Created test data and validations (included in DPP) Tested validations based on test data created prior to activation Performed discrepancy management effectively utilizing the DPP, including the DMRP Performed DCF creation Tracked all DM issues and ensured proper resolution by study completion Performed Quality Assurance maintained overall consistency and accuracy of data entry, DCF entry and DMR Communicated with clients/sponsors Assisted Monitors/Coordinators with any issues regarding queries
• Performed Internal kick-off meetings for study start-ups
• Followed Data Processing Plans (DPP) along with client/sponsor conventions
• Performed data and DCF entry using RDC
• Provided feedback using the Access database and verbal/visual communication to data entry team and other Data Clinical Managers
• Assisted in training new employees
• Performed AERS (Adverse Event Reporting System) reconciliation
• Prepared CRFs for data entry

Data Support Specialist

Responsibilities:

• Performed 1st, 2nd pass entry on medical case report forms
• Performed verification based on discrepancies resulting from 1st pass and 2nd pass
• Represented DSS at client and internal project team meetings
• Provided training to DSS team members
• Participated in team meetings, implemented standard procedures, determined workflow, and trained temporary staff members
• Solved routine problems of limited scope and complexity following detailed practices and procedures
• Performed CRF Tracking by using MS Access and prepared CRFs prior to data entry
• Assisted CDMs when necessary
• Delegated and managed archiving of projects
• Performed clerical work