Management Data

Professional Profile

Clinical Data Management Professional with more than 11 years experience for a top global pharmaceutical company with proven strengths in overseeing and monitoring data management processes, project management and external vendors in order to influence and achieve positive business outcomes. Used strong leadership and communication skills to facilitate diverse cross-functional teams to drive results. Reputation built for effectively meeting challenges in rapidly changing and dynamic environments while consistently delivering excellence.

Key Skills

• Risk Management • Customer Focus

• Project Metrics

• Data Management • Regulatory Adherence

• Expertise in FDA Audit

Professional Experience

Merck &Co 2000-2011

Global Data Management Specialist (GDMS) 2006-2011

Lead Data Manager responsible for managing end-to-end delivery of clinical data management services for multiple studies across multiple therapeutic areas including Oncology, Neurology and Cardiovascular. Experienced in Phase I-III clinical trials for design/set-up, in-life conduct, data base lock and archive. Developed and tested Phase Forward InForm Electronic Data Capture (EDC) system for clinical trials, delivering on time or prior to First Site Ready. Created and maintained CDM process control documents including edit check specifications, monitoring reports, Data Entry Guidelines and Data Management Plans. Reviewed clinical data according to Good Clinical practice (GCP).

• Managed the execution of deliverables for multiple oncology trials in controlled timelines with clinical and statistical teams ensuring high quality deliverables in a timely manner.

• As Subject matter Expert (SME) for Electronic Data Capture (EDC) Process, proactively identified deliverable issues/risks, defined risk mitigation and delivered outcome experience feedback to ensure ongoing process improvement

• Supported the clinical trial team members in study planning, project management, coordination, implementation plans including vendor management support

• Developed the study, start-up, documents, performed UAT and resolved production data issues including database lock issues including: design for eCRFs, Edit Checks, Entry Guidelines and Data Review plan for Phase I-III oncology Trials

• Monitored vendor performance during conduct resulting in decreased data integrity errors during database lock activities leading to on-time or early database lock. Built effective working relationships, leading to effective communication, resolution of issues and overcoming obstacles.

• Identified and resolved project specific challenges and worked cohesively with offshore builders to create and test unique reports to aid in medical monitoring for the protocol team.

• Reconciled the Serious Adverse Events in the CRF/eCRF and Clinical Database with the Central Safety Serious Adverse Events Database

• Provided feedback and remediation guidance for all issues including programming errors in the clinical database, eCRF layout parameters, data handling guidelines, data entry guidelines and data management plans to internal team members

• Received commendations from clients for managing vendors, project members, Core team members and timelines to achieve increase productivity, quality and timeline requirements of project tasks

• Provided ongoing coaching, mentoring and leadership development with team members to achieve effective innovation and long range planning

• Using effective project, risk and customer relationship management skills to ensure successful outcomes for various clinical trials

Data Operational Lead (DOL) 2002-2006

• Improved query response cycle time and data integrity 35%, by creating Standard Discrepancy Query Wording within the Data Management Process Documents

• Increased resource efficiency by 30%, as a result of creating an oncology specific report library

• Coordinated central vendor data management processes and supported Interactive Voice Response (IVR) requirements which ensured timelines were met

• Successfully achieved database lock for FDA submission

• Accomplished timelines 5 days early then project schedule for study start-up for Oncology trial

• Achieved Zolinza award as key contributor for oncology

• Successfully achieved database lock in 5 days to Last Patient Out, half of the projected timeline.

• Supported data review for high priority study of Dislipidemia including work queues

• Participated in writing protocols and study documents

Associate Medical Program Coordinator (Clinical MPC) 2000-2002

• Participated in all aspects of protocol initiation, review and completion including the testing, collection, management and reporting of data for project specific protocols

• Coordinated the preparation and production of a clean file database for reports and submissions to regulatory agencies

• Interacted and communicated with all levels of management to enable the development and production of clinical data management deliverables

• Performed leadership responsibilities including training and mentoring team members on new protocols

• Assured the quality and timely processing of clinical data

Education and Licensing

• Certificate course for QA/RA, Temple University, Philadelphia, PA

• Critical Care for Nursing in Arrhythmia, Bucks County Community College, Bucks County, PA

• General Supervisor License - G. Sup

• Registered Lab Technician - RLT

• Medical Laboratory Technologist – MLT, Bharat Laboratories, Mumbai India

• Bachelor of Science, Chemistry and Botany, Bombay University, Mumbai, India

Skills

• Experienced working with Electronic Data capture system (InFrom)

• Proficient in MS Office

Languages

• English

• Hindi

• Gujarati

United States Residence

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