Anisha Jiandani

Clinical Data Manager

Iselin, NJ

acd373@r.postjobfree.com – 732-***-****

- Strong experience in Clinical Data Management.

- Great knowledge in start up and conduct of Data base.

- Good understanding of SOPs, SWIs, ICH/GCP, FDA guidelines.

- Experience in EDC (RAVE INFORM & Bioclinica) and paper CRFs (AMOS).

- Capable of initiating, leading and guiding project teams.

- Good analytical, interpretation and decision-making skills

- Self-motivated and a good team contributor.

WORK EXPERIENCE

Clinical Data Reviewer

Covance Princeton, NJ – July2013 to present

- Working on two Phase 3 Cardiovascular studies

-Medical review and AE dedicated review on selected patients to study the safety and efficiency

-Daily review of data entered in database for any DE errors, inconsistency etc and issue queries wherever

necessary to obtain complete CRFs.

- SAE reconciliation process

- Adjudication data reconciliation for AE’s which are deemed necessary for adjudication purpose.

- Data review using SAs listings for specific CRFs like Acute hospitalization, AE V/s dose form etc

Clinical Data Analyst

Global PharmaTek, Piscataway NJ- Feb to Jul 2013

- Discrepancy management for Oncology studies.

- Interact with Client for CRF designing, Edit check finalization.

-Regular Discrepancy management using Rave reports.

-Review of CRFs for data discrepancies via edit checks and manual data checks.

Lead DM for device studies (Clinical Data Manager II)

DePuy Johnson &Johnson - Raynham, MA - August 2012 to February 2013

RAVE), work includes query management.

- Coordination with Clinical project leaders and CRA to maintain accurate patient data

- Migration activities (RAVE)- Edit check doc updating, CRF modification and identifying and correcting

the

misfiring checks, redesigning CRFs and updating documents

- QA and QC for RAVE and Oracle study and ensuring the database is corrected

- Maintain study specific documentation, communications and Data management manual

- UAT of RAVE database including writing test scripts, performing UAT of edit checks, CRF and

instructions

on RAVE database

- Creation of Validation Plan, Validation Report pre and post UAT for RAVE EDC system

- Acting as an expert on RAVE and guiding data coordinators on multiple RAVE projects.

- IVRS and database reconciliation and SAE reconciliation for safety data (for Oracle, RAVE and

BioClinica

systems)

- Creation of RAVE (5.6.4) study set up documents- eCRF, Matrix, DVS- (standard, study specific and

custom

function checks), e CRF entry guidelines, DMP, Instructions and coordinate with teams involved to ensure

Study goes Live per timelines.

Clinical Data Manager

Cognizant Technology Solutions Client-AstraZeneca Pharmaceuticals – India August 2009 to May

2012

1. Database Set Up (Start Up) followed by UAT of Database

- Conducted Process specific and Tool Specific Trainings for all key Stakeholders.

- Crucial (database) Set Up activities like creation of Data Standard Document (DSD), Visit Matrix, eCRFs

(Unique and expanded) and Data Validation specification (DVS), Data Extraction specification (DES),

SAE

Email/Potential Hy's law Alert Notification and User Acceptance Testing (UAT).

- Driving meetings between all the teams involved in the data management of the clinical trial.

- Review and contribute to preparation of Study Design Concept (SDC), good copy CSP and final

Protocol,

specifically related to data management activities.

- Creation of CRO DM documentations like Data Management Plan, Data Quality Plan and Validation

Plan,

Validation Report at different phases of UAT.

- Also to ensure that the documents are reviewed & approved by the appropriate Client personnel.

- Contribute to the Protocol Deviation incidents of trial subjects.

- Provide inputs to the stakeholders about the Third Party Modules (LAB) ad associated Lab codes and

Units.

- Creation of Test scripts for UAT.

- Validate programmed edit checks by entering test data.

- Expertise in preparing / compiling Data Management Plan (DMP) for assigned projects and manages

the

execution of plans.

- Create the Data Transfer Specification (DTS) to collect the Third party Data (LAB, PK and

BIOMARKER).

- Participates in the development and maintenance of Data Management Plans, EDC Use Guidelines,

Standard

Operating Procedures (SOPs) and Process Guides related to data management activities by utilizing

company

document control procedures and software.

2. Conduct Phase

- Performed the daily review of CRFs for completeness, accuracy and consistency of data

- Identification of data discrepancies via edit checks and manual data checks. Review, update and correct

data

in the clinical database based on resolved data queries.

3. SAE and External Data Reconciliation

- Performed reconciliation of Serious Adverse Events.

- Sound knowledge on reconciliation of laboratory or any external (third party) vendor data.

4. Quality Control Activities

- Performed Quality review of Oncology, Respiratory, Neuro pain & Infection Studies.

- Performed various Quality control checks on live data, both standard checks and study specific checks

before

freezing the database.

5. Close Out

- Creation and maintenance of study files and other documentation.

6. Coding

- Trained and certified in Client Specific Coding tool.

- Performs medical coding

7. Miscellaneous

- Prepared Change Request and Change Closure form for studies wherein database requires

modifications

either due to protocol amendment or study modifications that is Migration.

- Experience of more than 20 Rave database set up studies.

- Provided trainings to the investigators and monitors in investigator's meeting and monitor's meeting.

- Performed conduct activities on about 15 studies.

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