PROFESSIONAL SUMMARY:

• Overall 8.6 years of progressive experience in Clinical Data Management
• Experience in managing EDC trials, Phases I, II, III and IV trials.
• Expert experience in managing complex therapy area protocols like Oncology trials.
• Other Therapeutic experience includes Integrated Hospital care, Infection etc.
• Experience in Clinical Data Management Systems like Medidata Rave, Oracle RDC and Oracle Clinical.
• Experience on Case Report Forms CRFs Designing and CRF completion Guidelines CCGs .
• Managed and lead Clinical Data Management teams.
• Experienced with different aspects of data management which include CRF design, CRF review, Annotated CRF review, Database testing, Edit check validation, Test Plan and Test case preparation, Preparation of various Data Management Plan documents like Edit checks, Data validation guidelines, Global Rulings, Quality control plan etc., Monitoring reports and database specifications and DB lock procedures.
• Strong and comprehensive CDM skills panning from study start-up, study conduct and close out activities through NDA submission.
• Working knowledge in global clinical trial practices, procedures and methodologies.
• Involved in developing/reviewing departmental SOPs, guidelines and checklist
• Excellent understanding of ICH GCP knowledge 21 CFR Part 11 applicable to CDM activities
• Excellent knowledge in Good Clinical practices, CDM life cycle and FDA regulations.
• Sound understanding of Clinical Data Coding process.
• Sound Understanding of SAE / Safety data reconciliation, Lab data reconciliation process and J-review.
• Good interpersonal, leadership and communication skills - written and verbal, able to interact effectively as a team member and work independently with Minimal Guidance.

IT Skills:-

• Oracle Clinical-CDMS Tool
• Oracle RDC CDMS Tool
• Medidata Rave CDMS tool
• eTMF- Document Management Tool
• MS office: - Word, Excel, PowerPoint Outlook

PROFESSIONAL EXPERIENCE:-

confidential

Role: Team Manager /Onsite Lead Data Manager

Job Responsibilities:

• Serve as Lead for assigned trials.
• Responsible for managing all data management functions to ensure timely and quality database lock for Infection trials.
• Perform data management activities for studies conducted in-house oversee and coordinate activities of on-shore or off-shore CRO handling outsourced projects protocol review, CRF development, database set-up activities, data validation process medical coding, SAE reconciliation, etc. .
• Participate in the development of DM standards and documents.

IT applications used:

• Oracle Clinical CDMS tool
• Oracle RDC CDMS tool
• Jreview Reporting Tool

Achievements:

Working as Lead in assigned studies as Single Point of contact for the Client.

Phase III projects with therapeutic areas:

• Integrated Hospital Care sporadic inclusion body myositis Phase III
• Integrated Hospital Care Phase IIb

confidential

Role: Team Lead /Lead Data Manager

Job Responsibilities:

• Achieves successful delivery of data management deliverables meeting internal and external client needs
• Serves as the primary client liaison for data management issues
• Tracks milestones and tasks for assigned projects
• Ensures timely completion of all project status reporting
• Interfaces with Clinical Operations and Analysis Reporting project team members
• Develops a plan and oversees timelines for activities between the last patients last visit and the DB lock
• Provides study specific training as appropriate
• Ensures customer requirements are accurately captured and there is consistency across a client's studies
• Reviews data management plans for content and structure
• Provides case report form design oversight
• Ensures quality control steps are properly planned and completed on all studies

IT applications used:

• Medidata Rave CDMS tool
• Clin Phone CDMS tool
• eTMF Document management tool

Achievements:

• Worked as Lead Data Manager in assigned studies with team size of 6-8 members
• Got appreciation from senior management for successful efforts to meet the timelines
• Achieved the AZ Data Management Star Award in Cognizant

Phase I, II and III projects with therapeutic area:

Oncology Advanced Solid Tumors Phase III

confidential

Role: Team Lead /Lead Data Manager

Job Responsibilities:

• Achieves successful delivery of data management deliverables meeting internal and external client needs
• Serves as the primary client liaison for data management issues
• Tracks milestones and tasks for assigned projects
• Ensures timely completion of all project status reporting
• Interfaces with Clinical Operations and Analysis Reporting project team members
• Develops a plan and oversees timelines for activities between the last patients last visit and the DB lock
• Provides study specific training as appropriate
• Ensures customer requirements are accurately captured and there is consistency across a client's studies
• Reviews data management plans for content and structure
• Provides case report form design oversight
• Ensures quality control steps are properly planned and completed on all studies

IT applications used:

• Medidata Rave CDMS tool
• Clin Phone CDMS tool
• eTMF Document management tool

Achievements:

Worked as Lead Data Manager in assigned studies with team size of 6-8 members

Got appreciation from senior management for successful efforts to meet the timelines

confidential

Role: eCRF developer Technical Designer

• Worked as an eCRF Electronic Case Report Forms Developer for various projects in the specified deal from the pharmaceutical companies and performed core configuration and electronic case report forms for clinical data capture and management.
• Executed quality control and software quality assurance test scripts on eCDM systems, i.e. QC core configuration, QC eCRF.
• Developed electronic clinical data management eCDM systems. eCRFs, edit checks, matrix structures, workflows, system settings, role assignments etc.
• Interacted with onshore team on the projects. Initiated and handled eCDM team meetings with clients.
• Mentored new hires to configure and build systems.
• Communicated issues to QC management for escalation and participated in meeting to address research options.
• SPOC-A single point of contact for many studies.

Role: Sr. Technical Support Representative

• Handle inbound calls from customers for an ISP Internet Service Provider DSL client in US.
• Troubleshoot Problems related to connectivity, problems related to DSL, software installation and problems related to Hardware.
• Identify and maintain all queries and records of all incoming calls of customers and floor walking.
• Mentoring New Hire.
• Actively Participated in all the team activities.
• Handled call calibration with client for process improvement.
• Training coaching new hire regarding process.
• Quality FCR First Call Resolution SPOC of the team.

Achievements:

Got a Summit Award, and Best Team Member Award while working in Accenture Services Pvt. Ltd.

confidential

Role: Sr. Technical Support Representative

• Handled inbound calls from customers for Dell.
• Troubleshoot Problems related to Computers, problems related to Hardware, software installation and problems related to Hardware.

SKILLSETS:

Other skills Customer Service Technical Support