Manager Data

Mitali M. Raval, CCDM

Tel.: 785-***-****, 785-***-****

************@*****.***

PROFESSIONAL SUMMARY

. Certified Clinical Data Manager with over 4.5 years of experience in

Clinical Data management in working on a variety of changing

environments.

. Proficient in Paper & EDC trials

. Strong and comprehensive CDM skills spanning from study start-up, study

conduct, close out and Medical Coding activities

. Extensive knowledge of CRF design, Edit checks creation, data cleaning

and query process, Lab Data Reconciliation, SAE Reconciliation.

. Expertise in CRF tracking, Database QC, Database Audit.

. Experience in Oracle Clinical RDC, InForm, Rave, CRFTrack.

. Handled the maintenance of Trial Master File.

. Excellent understanding of ICH GCP knowledge, GCDMP & 21 CFR Part 11

. Experience in Vendor Management, Team management, Client Interaction and

communicating with different departments within the clinical research

domain.

. Demonstrated leadership ability to resolve issues, drive projects, and

meet deadlines.

. Good interpersonal and communication skills - written and verbal.

THERAPEUTIC EXPERIENCE:

. Oncology

. Multiple Sclerosis

. Parkinson's disease

. Ulcerative Colitis

. Gastrointestinal Disease

. Respiratory Disease

. Chronic Kidney Disease

WORK EXPERIENCE:

Company - Quintiles

Duration - Jan 2012 - June 2012

Designation - Clinical Data Coordinator

Therapeutic area - Rheumatoid Arthritis

Responsibilities -

. Perform/review SAE reconciliation

. Performed discrepancy management (both automatic and manual)

. Review data through listings and autoqueries.

. Creating edit check document for given protocol

. Issued and resolved DCFs

. Generate Data Clarification Forms (DCFs) if data is incomplete,

unclear or discrepant according to the validation specifications of

the Data Management Plan (DMP).

. Develop and test databases and edit specifications

. Ensured the studies are conducted as per the protocol requirements,

SOPs, ICH GCP and standard guidelines

. Leadership role in a specific area or process on a large study with

guidance

. Serve in the role of back-up to a Data Operations Coordinator and Data

Team Lead.

. Providing feedback to programming team in regards to the programmed

listings and edits

. Map the data trends with respect to the site and provide them to

Clinical team.

. Singly handling the CSSRS data for 4 studies.

. Responsible for cleaning the CM and CMRA data for extension studies.

. Manual review of the CRF data and data-dump listing

Company - DiagnoSearch Lifesciences (previously, iGate Clinical Research)

Duration - January 2009 to November 2010

Designation - Senior Data Validator

Therapeutic area - Oncology and Chronic Kidney Disease

Responsibilities -

. Vendor Management

. Providing feedback to the clinical team on protocol and CRF design.

. CRF designing

. Developing of study documents like Data Validation Plan, CRF Filling

Guidelines and Data Entry Guidelines etc.

. UAT Testing: Testing and executing Validation procedures.

. Generating queries to clarify and improve the quality of the data,

resolve them or initiate their resolution either via research associate

or directly with the investigational site.

. Performing the database testing and database audit as part of Quality

Control.

. SAE Reconciliation

. Freeze and lock data as appropriate in time for statistical review,

blinded interim quality review, interim and final database lock.

. Team Management

. Imparting training along with coaching and mentoring of new personnel in

the organization.

. Provide inputs to the Manager on resources, scheduling and timelines as

required.

. Client Interaction: Point of Contact of 3 studies for the client, giving

study related presentations to the clients.

. Contributed towards fine-tuning of standard DM processes, in

collaboration with global colleagues. Identifying and implementation of

best practices for DM.

. Liaised with monitor, database programming, medical coding and

statistical programming teams to ensure smooth functioning of studies.

. Therapeutic area - Oncology and Chronic Kidney Disease

. Responsibilities - . Vendor Management

. . Providing feedback to clinical team on protocol and CRF design.

. . CRF designing

. . Developing of study documents like Data Validation Plan, CRF Filling

Guidelines & Data Entry Guidelines.

. . UAT Testing

. . Generating queries to clarify and improve the quality of the data,

resolve them or initiate their resolution either via research associate

or directly with the investigational site.

. . Performing the database testing and database audit as part of Quality

Control.

. . SAE Reconciliation

. . Freeze and lock data as appropriate in time for statistical review,

blinded interim quality review, interim and final database lock.

. . Team Management

. . Imparting training to new personnel in the organization.

. . Provide inputs to the Manager on resources, scheduling and timelines.

. . Client Interaction: Point of Contact of 3 studies for the client,

giving study related presentations to the clients.

. . Contributed towards fine-tuning of standard DM processes, in

collaboration with global colleagues..

. . Liaised with monitor, database programming, medical coding and

statistical programming teams.

Company - Cognizant Technology Solutions (the project of Biogen Idec)

Duration - May 2007 to December 2008

Designation - Data Analyst (Clinical Data Manager & Medical Coder)

Therapeutic area - Multiple Sclerosis, Parkinson's disease, Ulcerative

Colitis and Rheumatoid Arthritis

Responsibilities -

. In addition to above responsibilities, performed Medical Coding -

Coding of Medical terms and Drugs in dictionaries like MedDRA, WHO

Drug in OC TMS.

Company - ALTANA PHARMA (A Nycomed Company)

Duration - August 2006 to May 2007

Designation - Jr. Data Documentation Officer

Therapeutic area - Respiratory and Gastro-intestinal

Responsibilities -

. Generating queries to clarify and improve the quality of the data,

resolve them or initiate their resolution either via research associate

or directly with the investigational site.

. Perform Quality Check of the data by manual review.

. Entering the data in the clinical database using 1st pass & 2nd pass data

entry.

Clinical Research Certification Programs

Hold Clinical Data Manager Certification from Society of Clinical Data

Management

Completed ICH-GCP certification for conducted by Barner's Institute as a

part of training by Quintiles

EDUCATIONAL QUALIFICATIONS:

1) Degree - Masters in Business Administration

Date of Completion - September 2011

Specialization - Information Management

2) Degree - Post Graduation Diploma in Clinical Data Management

Date of Completion - January 2007

Specialization - Clinical Data Management

3) Degree - Bachelor of Science

Date of Completion - February 2005

Specialization - Microbiology and Biotechnology

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