Senior Study Data Manager Resume Totowa, NJ - Hire IT People

SUMMARY:

Determined team - oriented Data Management professional with more than 18 years of experience in the pharmaceutical industry. Expert in the management of domestic and international Phase I - III clinical trials in the Therapeutic areas of Virology, Inflammatory Disease, and Oncology. Adept at assessing project parameters, extracting the essentials and achieving the desired results. Strengths include technology proficiency, analytical thinking, strong planning, problem solving and interpersonal skills.

TECHNICAL SKILLS:

Professional Competences: UAT Execution - Edit Check Creation - Generation & Resolution of Queries - Tracking - Data Analysis - Generation of Listings - SAE Reconciliation - - Training - Maintaining Trial Master File - Quality Assurance - Reviewing SOPs - Lab Data Management - Reconciling Lab Data Transfers - Testing Form Creation - Input on Designing Protocols - CRO Management - Project Management - Time Management - Data Management Plans - Vendor Management

Systems: MACRO, RAVE, IFORM, IReview - JReview And ORACLE

PROFESSIONAL EXPERIENCE:

Confidential, Totowa, NJ

Senior Study Data Manager

Responsibilities:

I lead global studies in the areas of Data Management and Lab Data Management services.
Data Management services include Study Start Up activities, UAT, Discrepancy Management, SAE Reconciliation, Metrics, and attending study team meetings while working directly with Investigators and Monitors to ensure we are providing quality data and timelines are met.
Lab Data Management services include range entry, running reports, analyzing outputs and posting queries as necessary.
Within the FSP I am a trainer on systems and tools use within our function and with our clients.

Confidential, Woodcliff Lake, NJ

Senior Study Data Manager

Responsibilities:

I was responsible for leading the clinical data management activities for 4 global studies.
These activities include but at not limited to CRF design, database development, processing external data, data review, SAE reconciliation, coding and database close/lock procedures in accordance with Confidential SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements.

Confidential, Nutley, NJ

Senior Study Data Manager

Responsibilities:

Manage the delivery of data management activities: during study start, provide input into the development of the protocol and other study documents; conduct User Acceptance Testing; ensure compliance with ICH GCP guidelines and SOPs; proactively mitigate risks
Chair Study Data Management team meetings; negotiate timelines for action plans; coordinate with Study Management Team functions; represent data management at Investigator meetings and other events with local/global audiences; and participate in study debrief meetings.
Lead the data management actives for a global project with 4 studies, and over 4000 patients and involving 28 countries.
Project was concluded on-time and on-budget.
Developed, planned and conducted training events for data management/clinical science community on appropriate Query and Validation writing for US based colleagues which led to development of new standards.
Facilitator for Project Data Management Forum which provided Clinical Data Management an arena to discuss topics and establishing best practices which adopted harmonized approaches, and reduced duplication of effort.
Organized and presented Monitor workshops on new systems and tools for 4 global studies ensuring data was collected and recorded in the database according to protocol.
Contributed to data management resources planning, timelines, risk management and quality plans with the study management team in areas of Oncology, Rheumatoid Arthritis and Virology.
Presented Clinical Data Management process initiatives at Global Investigator Meeting (Principal Investigators, Coordinators and Vendors) for new and ongoing studies.

Confidential, Nutley, NJ

Data Manager

Responsibilities:

Reviewed Case Report Forms (CRFs) for clarity, consistency and logic
Created Data Management Plan including: Annotated CRFs, CRF Review Guidelines,
Data Entry Guidelines, Data Entry Validation Document, Edit Check, Specifications
Query Generation and resolution for large 5000 patient global study
Monitored and tracked data flow identified trends and provide supporting metrics
Prepared and executed validation test plan for data entry application in Oracle Clinical

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Senior Study Data Manager Resume

Totowa, NJ

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