Hands on, consistent, solution oriented Clinical Data Management professional with 10+ years of experience in cleaning and validating clinical trial data.

Skills Highlights

●Strong knowledge of Clinical Data Management (CDM), Clinical Trials and related areas with 10+ years of experience in CRO and Pharma industry.

●Combines resourcefulness, technical abilities and problem-solving skills with data management knowledge to consistently deliver improved results. Team player dedicated to quality, continuous improvement and bottom-line objectives.

●Extensive work experience through all phases of CDM starting with data validation, project initiation requirement gathering, requirement analysis, database design, and reporting.

●Manage clinical trial start-up, maintenance and close-out activities.

●Sound knowledge about Clinical Trials and its regulatory requirements.

●Gained Extensive Experience on following Database Tools: OC, InForm 6.0, RAVE, Jreview, eCaseLink 8.0, TOAD(SQL Based tool) and eTMF

●Training new employees

Therapeutic Areas Experience

●Diabetes

●Growth Hormones

●Haemophilia

●Oncology

Other Technical Skills

●MS office (Excel, Word, PowerPoint)

Education

●PG Diploma in SAS from ICRI - 2008

●PG Diploma in Data Management from ICRI – 2007

●B. Pharm from Acharya Institute, Bangalore in 2005

●B.Sc from Lucknow University, Lucknow in 1999

Employment History

Current Organization: Accenture Solutions Private Limited

Designation: Medical Services Specialist (From October 22 2018 till date)

Role and Responsibilities

Responsible for study level data management activities for assigned protocols including clinical data review and cleaning

Responsible for the development of study database and provide inputs to client on: review protocol, review of study Toolkit and timelines, data management plan with the data review strategy, listing specifications review, transfer agreements and eCRF instructions review.

Develop procedure/edit check specifications and follow up on edit checks and UAT completion

Responsible for proactively identifying and resolving issues noted during data management which impact the overall timelines, inform client and coordinates follow-up.

Responsible to identify and document risks issues for internal activities, develop mitigation plans, and shares with client. Engage client to assist in the resolution for more complex issues.

Responsible for data management review to lock activities of assigned protocols and overseeing database update process. Answer and resolve routine data related questions.

Present data related issues and drives resolution to ensure that data management activities are in compliance with global and program level standard requirements, study timelines, client SOPs and regulatory guidelines or regulations.

Responsible for data quality and uses this to drive all data management review to lock related activities for the protocol. Undertakes evaluation, providing database quality metrics to team as needed. Suggested both technical and process improvements based on findings.

Review study database lock timelines and provide inputs regarding study lock activities and timelines to client. Coordinate and drive the completion of all database lock activities to the standard expected, ensuring effective use of resources.

Previous Organizations

India Document Solutions Private Limited

(Subsidiary of Document Solutions Group; Malvern, PA, US)

Designation: Senior Clinical Data Manager (From April 18 2017 – September 28 2018)

Roles and Responsibilities

Trial start-up

Assist Lead Data Manager to review eCRFs and study protocol

Help LDM in creating edit specifications

Execute user acceptance test

Help LDM in preparation of Data Entry Guideline

Help LDM in presentation/training at Investigator Meetings

Conduct & Closure

Review ongoing clinical study data

Get the coding done of study data with standard dictionaries (MedDRA, WHO Drug)

Create ad-hoc listings to review ongoing clinical study data

Review queries issued by resources

Help LDM in database lock processes

Perform laboratory data reconciliation

Perform SAE data reconciliation

Issue query as per sponsor listing

Other Activities at IDSG

Created daily status tracker for team.

Created metrics tool in order improve process.

Created SAE reconciliation tool.

Helped colleague’s in Co-coordinating for study handling.

Actively participated in colleague’s trial related task where help is required.

Impart Training to all new joiners.

Currently performing additional responsibility of CISO (Chief Information Security Officer).

Novo Nordisk Service Center (India) Private Limited

Designation (at the time of leaving organization): Senior Clinical Data Manager (From September 10 2007 – April 07 2017)

Roles and Responsibilities

Trial start-up

Handling all trial related documentation including protocol and other start-up documents. Handled all trial tool execution related to the DM systems (CDMS, EDC) with regards to set up phase; and the integration of these systems to IVRS and CDW (when included).

Conduct & Closure :

Can perform loading of data, deliver various types of routine reports/data listings up to database lock. Handle data transfers safely and with good QC documentation. Handle data cleaning activities including queries. Handle Quality Control audits, blinding in connection with data handling and especially data list generation for the Data base reviews.

Handle archiving of all DM documents.

Ensure the completeness and validity of the clinical trial data that has gone through double data entry (query resolution & discrepancy handling)

Review and resolve discrepancies identified by the system or through manual checks as per guidelines.

Issue Data Clarification Forms (DCF) as and when required. Track, review and close all DCF responses received.

Generate and review CRF Summary report, SAE reconciliation and track missing CRFs etc

Review and address all clinical data review issues. Creating Standard queries for the team.

Provide expert comments and feedback on quality initiatives.

Ensure timelines set by the study group in terms of pages produced and clean patient delivery are met.

Mentor CDAs to perform entry until they are well trained.

Created automated trackers in excel for issues at Study level, minimizing the time and resource required.

Helped Peer Data Managers in ensuring Lock and freeze of the Study within the time lines.

Other :

Knowledge the process of outsourcing follows up on CRO/Vendors; takes action/contact in case of divergence from contract. Secures quality assurance of deliverables.

Ability of reviewing documentation from a DM perspective. Comments from review are at a level which ensures successful trial conduct.

Medical coder : Hands-on on medial coding (Worked as a medical code.

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