SUMMARY:

• 18 years of pharmaceutical industry experience, primarily in Data Management as a Lead Data Manager in both an outsourced and in - house setting
• Proficiency with EDC systems Medidata RAVE, Inform, Clintrial 4.4, Clincase, OCRDC; Data Review systems J-Review, I-Review; and Document Management systems Documentum, Sharepoint, ARISg, extracts from ARGUS, MedDRA
• Experience in the Oncology, Cardiovascular, Metabolic, Infectious Disease, and Reproductive Health therapeutic areas in multiple phases
• Proven ability to work within Global data management team environments, including international travel to represent company brand.
• Familiarity with Good Clinical Practices (GCP), Code of Federal Regulations (CFR) and Confidential Guidelines, SDTM needs to inform data collection needs (CDASH).
• Working knowledge of Medical Terminology, Anatomy and Physiology, Pharmacology, Pathophysiology.
• Active, self-motivated, and high emotional intelligence demonstrated in global team workspaces.

PROFESSIONAL EXPERIENCE:

Confidential, Newark, NJ

Data Management Project Lead

Responsibilities:

• Serve as Lead Data Manager for Phase I Type 2 Diabetes, Phase II Endometriosis and Phase III Oncology trials for three major Sponsors
• Liaison between US office and company headquarters in France to harmonize study portfolio for US-based studies, which includes regular travel.
• Project Lead responsibilities included:
• Lead specification of the Clinical Database (including Post Production Changes) and CRF design with annotations according to the protocol with Study Team members using established standards
• Author and review CRF completion guidelines
• Perform User Acceptance Testing for the clinical database
• Develop and lead the clinical team review of the Data Management Plan (DMP)
• Coordinate development of the Data Review Plan (DRP) (including specification of data listings needed to facilitate data cleaning)
• Perform SAE reconciliation and external vendor data reconciliation (including ePRO/eCOA data)
• Lead data lock and archiving activities
• Review SDTM mapping using proprietary SAS database and tools
• Develop edit check specifications for clinical database and Protocol Deviations specifications according to DV List and study protocol
• Decision making responsibilities regarding trial database and CRF designs, timelines, vendor selection, and Sponsor interaction
• Review budget for data management activities and costs in contracts.
• Coordinate input from physicians, medical writers, monitors, programmers, clinic staff and statisticians to create an appropriate database to ensure data integrity

Confidential, Florham Park, NJ

Clinical Data Manager

Responsibilities:

• Served as in-house Lead Data Manager for one Phase II Infectious Disease trial for Bacterial Pneumonia and as supporting Data Reviewer for one Phase II infectious disease trial for Influenza
• Lead Data Manager responsibilities included:
• Led specification of the Clinical Database (including Post Production Changes) and Case Report Form (CRF) design with annotations according to the protocol with Study Team members using established standards
• Ensured CRF completion guidelines were authored by the clinical team and approved version filed in the TMF
• Led User Acceptance Testing for the clinical database
• Developed the Data Management Plan (DMP) with coordinating team input
• Coordinated development of the Data Review Plan (DRP) (including specification of data listings needed to facilitate data cleaning) and ensured study team compliance during the study
• Performed SAE reconciliation and external vendor data reconciliation (including ePRO/eCOA data)
• Led data lock and archiving activities, conducting review of clinical trial data and performing all tasks required for database lock
• Managed multiple study sites and CRO oversight on Phase II trials.
• Presented at company wide presentation/workshop on MBTI for better working relations
• Assisted in developing SOP and Working Practices.
• Oversaw external vendor progress and created study status, metrics, timeline slides for team updates at weekly meetings
• Decision making responsibilities regarding trial database, timelines, and CRO oversight for Phase II Infectious Disease trial.

Confidential, Quincy, MA

Lead Program Data Manager

Responsibilities:

• Served as Data Management Lead for select sites on a Phase II Type 2 Diabetes trial with a major Sponsor
• Led the UAT testing to support Inform database build
• Ensured database and edit check specifications met all protocol needs
• Responsible to ensure vendor reconciliation edit checks matched need for multiple vendors
• Performed an external audit of UAT review and testing of CRO activities
• Accurately pinpointed UAT/database build issues and proactively provided solutions
• Met daily timelines to reach ultimate FDA blank CRF submission goal
• Provided advisory support to study team for database build
• Provided oversight of data management events and provided timely status reports to Project Director.
• Chaired meetings to discuss the status, metrics and timelines of project, and to provide guidance to coworkers.

Confidential, Woodcliff Lake, NJ

Clinical Data Manager

Responsibilities:

• Served as Data Management Lead for select sites on an Oncology Ph II study and supporting DM for multiple Phase II and II studies
• Performed daily data management activities such as cleaning, writing and resolving queries, tracking the status of queries in the Inform EDC database for Phase II and III studies
• Led the SAE reconciliation and 3rd party vendor reconciliation activities for an Oncology Ph III study
• Assisted in the development of DMPs, edit check specifications and Data Review Plans, updated study specific information for a new Phase II trial
• Proactively created ad hoc and status reports for the Lead Study Data Manager

Confidential, Berkeley Heights, NJ

Sr. Clinical Data Manager/Team Lead

Responsibilities:

• Oversaw CRO Data Manager activities, operated as Team Lead when assigned
• Provided oversight of external data vendor activities to ensure quality and timely deliverables
• Performed all data management daily tasks of writing, reviewing queries, resolving and updating database
• Led data review and coordinated database lock preparation tasks for an Oncology Phase IV Registry Trial data
• Assisted in the development of DMPs, Edit Check Specifications and Data Review Plans for a Phase II Oncology trial
• Represented the data management function at weekly meetings to report on status of study, timelines and metrics
• Specified and developed customized adhoc reports from Medidata RAVE database
• Maintained manual review activities for database lock procedures, including ad hoc queries
• Decision making responsibilities regarding CRO oversight and study management as delegated by Project Manager
• Worked very closely with the Clinical Team to maintain the integrity of the study

Confidential, East Hanover, NJ

Clinical Data Manager

Responsibilities:

• Provided supporting Data Manager support, leading data review, post production change testing, external data reconciliation activities for a Ph III Oncology study using OC/RDC
• Specified and generated reports to meet clinical team needs using J-Review
• Responsible for leading database lock preparation activities
• Oversaw and confirmed data review activities performed by CRO DMs contracted to perform data management functions
• Performed SAE data reconciliation and review of 3rd party RECIST data output

Confidential, Princeton, NJ

Clinical Data Analyst

Responsibilities:

• Monitored and ensure study timelines were met for assigned studies
• Provided input and review of clinical trial database design specification, including leading User Acceptance Testing (UAT) activities
• Created an improved tracking system for the Manual Data Clarification Forms and Discrepancies for the SAS program
• Responsible for the review and correction of study specific validation checks and necessary reports to ensure high quality and consistent data
• Created and defined edit checks for SAS and Oracle Clinical databases to be programmed for study/project
• Successfully integrated (loaded) SAS datasets into an Oracle Clinical database and performed User Acceptance Testing (UAT), resolved any issues that related to the process
• Reviewed database outputs created by database programmers
• Proactively provided input and suggestions for program changes and edits
• Developed Case Report Form guidelines and data entry conventions.
• Daily tasks included: Cleaning, updating, validating, query resolution, reconciliation, and maintenance of the SAS and Oracle Clinical databases for Liver and Lung Fibrosis studies.
• Coded Case Report Form verbatim terms using Confidential /i3 or sponsor supplied dictionaries.

Confidential, Florham Park, NJ

Clinical Data Manager

Responsibilities:

• Served as lead for Local Lab Reconciliation in legacy proprietary Confidential clinical database system and supporting DM for large Phase III Oncology study
• Performed data cleaning, UAT for Post Production Changes, external vendor data reconciliation, and SAE Reconciliation for the proprietary EDC system, Phosco and in the central Clintrial 4.4 database for an Oncology study
• Generated ad hoc reports to support clinical team data review using I-Review
• Identified errors/inconsistencies and resolved them or initiated their resolution either via the field monitor or directly with the investigational site to ensure high quality and timely database locks.
• Reviewed and contributed to the preparation of protocols related to the data management section, visit schema, and study design for a Phase II Oncology study
• Prepared Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic and paper.
• Coordinated activities for Database Freeze and Lock in time for statistical review, blinded interim quality review, and interim/final database lock timelines
• Delivered on the electronic clinical database and study-specific eCRF to sites
• Performed data management activities for multiple clinical trials, including SAE reconciliation
• Responsible for identification of protocol deviations, review of lab ranges for missing or inaccurate values, tracked data flow and review status, and reviewed study documentation in the TMF for audit readiness