Clinical Data Manager

Name: Deepika Balkrishna Zende

Contact No.: 992*******

Email ID.: acy8pk@r.postjobfree.com

PROFESSIONAL EXPERIENCE

Current Experience:

Company Name: Cognizant Technology Solutions.

Designation: Junior Data Analyst

Duration: 27th Jan, 2016 Till Date

Role: Clinical Data Manager

Responsibilities

Review and understand the study protocol and the timelines.

To prepare and update clean patient tracker as per the client requirement.

To review SAE narrative and issue queries for discrepant data.

To be aware and updated of the client quality standards and undertake any relevant training for the same if required.

To perform data reconciliations of external (Lab, ECG, IVRS, PK, eDiary, PFT, CSSRS, DA) data with the use of different tools and software’s.

Following up with site RSM and clinical team during COV of a site.

Escalate any discrepancies in the clinical data to the client study manager as appropriate.

Provide data listings and metrics in the required format as documented.

Co-ordinate with the client study manager with respect to any unresolved queries & close the same.

To identify site trends by performing trend analysis and highlight them to study team with possible reasons and resolutions.

To ensure an error free, quality data with no open queries.

Study closeout procedures including data review for completeness and signatures, and finally locking/freezing of forms/visits as appropriate with error free data processing.

To conduct and attend study teleconference with client staff to discuss the study progress and any issues that needs study team intervention.

Database and Tools Used

Inform version 4.6 and 6.0

To prepare different manual checks

Skill and Summary

In-depth knowledge of the methods and principles of ICH-GCP.

In-depth knowledge of the processes of clinical data management systems, clinical trial methodology, GCP and medical terminology.

Attention to detail with good research skills.

Possess excellent project management, coordination and organizational skills.

Excellent communication skills with ability to work in a team.

Proficient in basic computer and software applications.

Previous Company Name: Metropolis Healthcare Ltd

Designation: Clinical Research Project Coordinator

Duration: 19th Nov, 2012 To 23rd Jan, 2016

Responsibilities:

Project Set Up:

1.To Initiate project set up activities after the project awarded to Metropolis, this includes but not limited to; Customizing the Test Requisition Forms (TRF), Coupons, Project Standard Operating Procedure (SOP), Test Profiles, Workflow, Dummy reports for the parameters to be analyzed at Metropolis, Kit letters, Request for Client codes, Logistics set up for the timely receipt of specimens at Metropolis and ensuring that the project set up is complete prior to First patient first visit (FP.)

2.Initiating project set up activities.

3.Submitting draft version of documents to QA -Auditor and Sponsor for approval.

Project Management:

1.Checking Test Requisition Forms and coupons before authorization of reports.

2.Releasing the reports within Turn Around Time (TAT).

3.Arranging camps, home visits of the project patients with respect to project requirement and provide details about the arrangement to respective Sponsor as per the project requirement.

4.Arranging specimen pick up through Metropolis logistic personnel or through courier tie up company.

5.Coordination with sister labs or collection centers or franchisee with regards to project specimens.

6.To ensure that the Call alerts, Test Not performed or any other result deemed important be conveyed to the Sponsor and the same be documented.

7.Documentation of all “Problem data” and “Problem specimens” communications with the Investigator.

8.Ensure that the necessary specimen status, kit and report dispatch status and kit inventory is updated in a timely manner.

9.Resolving any queries from Sponsor.

10.Participate in telecon to update the Sponsor of the project progress.

11.Escalation of issues/Complaints to the QA team.

12.Ensuring that the project is managed as per the SOP's and any guidelines laid down by the Sponsor.

Project Close Out:

1.Ensuring that all the reports are released and perform QC checks of all documents prior to the Archival.

2.Appropriate archival of all study documents with the necessary documentation following project close out.

Additional Responsibilities:

1.Assisting the QA team during Sponsor audits and ensuring that the necessary updated documents are presented to the auditors.

2.Generating MIS reports.

3.Checking invoices and providing supporting documents at the time of invoicing.

EDUCATIONAL BACKGROUND

Sr. no.

Degree/ Course

University

Class

Year of Passing

1.

BSc - Biotechnology

Mumbai University

Second Class

2012

2.

HSC

Maharashtra State Board

First Class

2009

3.

SSC

Maharashtra State Board

Distinction

2007

Additional Qualification

MSc. In Clinical Research and Regulatory Affairs from Sikkim Manipal University.

PERSONAL PROFILE:

Name: Miss. Deepika Zende.

Address : Road Pali, Kalamboli, Navi Mumbai

Date of birth : 27th Nov 1990.

Sex : Female.

Nationality : Indian.

Marital Status : Unmarried

Languages: English, Hindi, Marathi

I hereby declare that the information furnished above is true to the Best of Knowledge and I bear the responsibility for the correctness of the above mentioned particulars.

Name: Deepika Zende

Date: 05-01-2016

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