SUMMARY

• 17 years data management experience
• Lead data manager for numerous clinical studies
• Thorough, effective Clinical Data Manager that works well with cross - functional teams and independently. Takes initiative and is goal oriented.

PROFESSIONAL EXPERIENCE

Confidential, Summit, N.J

Senior Clinical Data Manager

Responsibilities:

• Reviewing Oracle Inform and Medidata Rave eCRF data, including use of standard reports and writing ad-hoc JReview reports.
• Query management in Medidata Rave, Oracle Inform, and Oracle Clinical to ensure accuracy, completeness, and protocol adherence.
• Providing input into data quality/review reports.
• Reviewing User Acceptance Testing scripts and performing database and edit check testing.
• Development and maintenance of Data Handling Conventions.
• SAE reconciliation.
• ECG and PK reconciliation.
• Oversight of outsourced studies.

Confidential, Chatham, N.J

Clinical Data Analyst

Responsibilities:

• Lead of clinical studies including initiation, ongoing conduct, reviewing and querying of CRF data, and database lock.
• Designing CRFs and CRF instructions.
• Review of CRF data against electronic database to ensure accuracy and completeness.
• Identifying and coding protocol deviations.
• Coding of medical terms using the standard dictionary MedDRA.
• Study safety data review and interpretation.
• Reconciliation of serious adverse event report database against the clinical database.
• Review and preparing clinical data information for insertion into NDA submission.
• Preparing safety section of Clinical Study Reports for FDA submission.

Confidential, East Hanover, N.J

Clinical Data Manager

Responsibilities:

• Developed study data specifications and management strategy including eCRF/pCRF design, validation checks, quality review listings, Data Handling Guidelines and Conventions.
• Identified issues in eCRF data and ensured resolution through generation of queries.
• Identified protocol deviations.
• Reconciled serious adverse event reports and other external data sources against the eCRF database.
• Ensured data quality was in accordance with all agreed operating procedures.
• Represented Data Management function in international clinical teams and in Clinical Development initiatives. Served as committee member seeking to harmonize handling of third-party clinical imaging data.

Confidential, East Hanover, N.J

Senior Clinical Coding Specialist

Responsibilities:

• Performed accurate and consistent coding of medical terms and therapies across clinical trials using MedDRA and WHODRL coding dictionaries, including final approval of coding assignments.
• Maintained awareness of MSSO guidelines for medical coding and established and maintained global coding conventions and working practices accordingly.
• Reviewed and maintained global synonym coding dictionaries; requested addition of new dictionary terms for MSSO and WHO review as needed.
• Evolved into the Autocoder software application expert (supporting Data Management, Coding, Application Development, and Application Support). Major accomplishments included: training; reporting and managing Autocoder application issues; requesting system enhancements; and prioritizing open issues for resolution.
• Extensive experience providing ongoing end-user input as member of the Autocoder Application Development Team and in various electronic data management initiatives such as evaluating external EDC applications which included Medidata Rave and Phase Forward InForm.
• Served as Subject Matter Expert for the Central Coding Novartis Internal Practice including regular presentations to Data Management colleagues.

Confidential, Summit, N.J

Clinical Coding Coordinator

Responsibilities:

• Assisted Data Management Heads in the initialization of a global centralized medical coding group.
• Developed Standard Operating Procedures for centralized coding.
• Evaluated the coding functionality in proposed and current software applications.
• Devised strategies for converting from existing to new medical and therapy dictionaries as member of the Novartis Dictionary Task Force.

Confidential, Summit, N.J

Clinical Data Scientist

Responsibilities:

• Determined CRF design, quality control specifications, and data quality/review reports.
• Ensured data was entered into the electronic database.
• Coded medical and therapy terms using standard dictionaries.
• Reviewed CRF and laboratory data, including use of standard reports and writing ad-hoc SQL scripts.
• Queried data to ensure accuracy, completeness, and protocol adherence.

Confidential, Summit, N.J

Clinical Research Associate

Responsibilities:

• Determined CRF design, quality control specifications, and data quality/review reports.
• Initiated new trials and provided clinical monitoring of ongoing trials, including extensive interaction with study site investigators, coordinators, and field monitors.
• Handled various trial administrative duties such as tracking enrollment, study progress, investigator budget grants.
• Ensured data was collected and entered into the electronic database.
• Coded medical and therapy terms using standard dictionaries.
• Reviewed CRF and laboratory data, including use of standard reports and writing ad-hoc SQL scripts.
• Queried data to ensure accuracy, completeness, and protocol adherence.
• Prepared reports to FDA, working in conjunction with clinical physician.