Praneeth

Phone: 720-***-****

Email: ac4pyo@r.postjobfree.com

PROFESSIONAL SUMMARY

7+ years of experience working in the field of Clinical Data Management delivering Data Review and Management objectives in various clinical studies and phases in a timely manner

Worked on multiple projects simultaneously with taking little to no guidance from the project managers

Extensive experience in working with Phase I through Phase IV of clinical trials using both Paper and EDC systems

Experience in working on various EDC databases including Medidata Rave, Oracle Clinical (RDC) and Phase Forward Inform

Extensive experience in set up new studies in Clinical Research Management System

Developed and maintained Data Management Plans (DMP) and made sure they are followed throughout the project life cycle.

Experience in Team management, Vendor Management, Client Interaction and communicating with different departments within the clinical research domain.

Have good experience in creating all study related documents (CRF specifications, DMP, CCI, .etc)

Providing study/process related training to team members.

Working experience in developing Data Transfer Agreements (DTA) with external vendors

Communicated and coordinated with different global teams in various studies.

Extensive knowledge in different phases of the clinical data management including study start up, study conduct and study lock

Worked extensively during study start up on CRF designing providing study specific and protocol specific guidelines

Provided and assisted in creating Edit Checks, Query Logics and User Acceptance Testing (UAT).

Worked extensively during study conduct on validating the data, cleaning the data, Discrepancy management, Lab Reconciliation and SAE Reconciliation.

Worked extensively on study closing activities including Data Review, Data freezing and Study Lock

Assisted in performing clinical data interim analysis

Worked on compliance checking of data review guidelines in accordance with the regulatory guidelines

Involved in the audit process of the data management with the sponsors

Knowledge in Medical Coding with MedDRA and WHO Drug

Thorough knowledge in Database QC, CRF tracking

Sound knowledge on ICH-GCP and 21 CFR Part 11 guidelines

Good verbal, written, interpersonal and communication skills

THERAPEUTIC AREAS

Oncology

Respiratory

Multiple Sclerosis

Parkinson’s disease

chronic kidney disease

Ulcerative Colitis

Rheumatoid Arthritis

SKILLS

Database Setup Data Review

DMP Regulatory Compliance eCRF design Data Analysis

Data Entry: 1st and 2nd pass entry of (CRFs) Discrepancy Management

SAE Reconciliation

PROFESSIONAL EXPERIENCE

Company –Novartis, New Jersey

Duration- Sep 2016 to Till Now

Designation – Sr. Clinical Data Manager

Therapeutic area - Rheumatoid Arthritis, oncology, chronic kidney disease

Responsibilities

Assisted in updating data management standard operating procedures (SOPs) as needed

Trained clinical team and other DM team members on the project specifics and served as primary contact for data on the project.

Handled Complete life cycle of Data Management in Phase 2 and 3(From study setup to close out).

Fine-tuning of standard DM processes, in collaboration with global colleagues. Identifying and implementation of best practices for DM.

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

Archived relevant study documentation and submitted the document to the Document Records Center (IDRC) for indexing.

Liaised with monitor, medical coding, database programming, and statistical programming teams to ensure smooth functioning of studies.

Managed team of four on oncology study. Conducted team meetings; managed weekly schedules and confirmed accuracy of timesheets

Implemented solutions to issues that arise during the development, management and close out of clinical studies.

Resolved data discrepancy and related issues by interacting directly with investigator sites

Point of Contact for studies for the client, giving study related presentations to the clients.

Primary Liaison from CDM team with clinical team, Biostatisticians, both internal and external team

Work closely with database developers on the design, testing and implementation of study databases.

Generated study specific reports, ad hoc reports and metrics to track the status of the study.

Team Management: Supervise and co-ordinate all the data management activities for the studies assigned to the group and ensure appropriate distribution of work among direct reports. Daily monitoring of DM activities carried out by internal and FSP direct reports

Developed and Maintained project documents like Data validation documents, Data Management plan (DMP), CRF completion guidelines (CCGs), Data Transfer Agreements (DTA) and Departmental SOPs.

Participated in CRO selection

Assisted in database upgrades/migrations including performing User Acceptance Tests.

Served as the DM representative on clinical project teams that are developing NDAs

Developed annotated CRF’s based on the protocol specifics .

Liaised with monitor, medical coding, database programming, and statistical programming teams to ensure smooth functioning of studies

Ensured the studies are conducted as per the SOPs, ICH GCP, protocol requirements and standard guidelines

Reviewed and tested eCRF screen design and written data management plans for EDC.

Executed SAE reconciliation and external vendor data reconciliation for several clinical trials

Responsible for supporting database-locking activities, including planning and executing listing reviews and identifying remaining clinical and monitoring tasks.

Tracked status and progress of data management for allocated projects/trials

Ensured FDA regulatory standards compliance (particularly 21 CFR part 11), performing quality assurance on electronic data capture tools.

Contributed towards developing guidelines/checklist that aids in streamlining of activities for Data Management (DM) during study closeout.

Company –MMS Holdings,Canton,MI

Duration- March 2015 to Aug 2016

Designation –Lead Clinical Data Manager

Therapeutic area - oncology, multiple sclerosis, respiratory

Responsibilities

Reviewed clinical research study protocols

Participated in study set-up, validation and implementation of clinical databases

Developing of study documents like Data Validation Plan, CRF Filling Guidelines and Data Entry Guidelines etc.

Coordinated with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required.

Review data through listings and autoqueries.

Manual review of the CRF data and data-dump listing

Client Interaction: Point of Contact of 3 studies for the client, giving study related presentations to the clients.

Performed clinical trial data management activities for Phases 1& 2 (study set up and conduct)

Proactively identified potential study issues and recommended implementation solutions

Tracked data management issues and ensure proper resolution by study completion

Generated and resolved queries via Oracle Clinical and INFORM.

Participated in database designs and forms development

Served in the role of back up for data team lead in managing the day today CDM operations

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

Performed UAT for Screens and Folder dynamics

Developed test cases and performed UAT of edit checks and validation of manual listings.

Ensure adherence to the basic protocol requirements, SOP's, ICH GCP and Standard Guidelines.

Assisted in developing case report forms and CRF completion guidelines

Worked on Lab reconciliations including Local labs and central labs

Vendor Management: Creating Data transfer agreements, working with the vendors on regular imports and reconciling the data.

Performed ECG Reconciliation and SAE Reconciliations

Contributed towards providing guidance and suggestions on the standard DM processes, in collaboration with global colleagues. Identifying and implementation of best practices for DM

Oversee data-management lifecycle of large clinical trials, composing and verifying reports and results.

Represented data management and coordinated with internal/external teams

Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock.

Company –Abbott Labs, North Chicago, IL

(Through Cognizant)

Duration- Dec 2011 to Jan 2014

Designation - Clinical Data Manager

Therapeutic area –Oncology, Parkinson’s disease and Chronic Kidney Disease

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.

Performed clinical trial data management activities for Phases I to IV

Reviewed and tested eCRF screen design and written data management plans for EDC and paper based trials

Medical Coding – Coding of Medical terms and Drugs in dictionaries like MedDRA, WHO Drug in OC TMS.

Involved in creating Edit check specification and performing UAT using Phase forward INFORM

Performed QC of data for several trials

Interacted with the sites and CRA to coordinate error resolution using data clarification forms

Generated and resolved queries via Oracle Clinical and INFORM

Executed SAE reconciliation and external vendor data reconciliation for several clinical trials

Responsible for supporting database locking activities, including planning and executing listing reviews and identifying remaining clinical and monitoring tasks

Responsible for aiding in the closing of a database for a deliverable to the FDA

Ensured FDA regulatory standards compliance (particularly 21 CFR part 11), performing quality assurance on electronic data capture tools

Company - Cognizant, Bangalore, India

Duration – Aug 2009 to Nov 2011

Designation - Clinical data coordinator

Therapeutic area –Oncology, Parkinson’s disease and Chronic Kidney Disease

Responsibilities

Performed data entry into the study database using 1st pass and 2nd pass data entry methods

Providing feedback to the clinical team on protocol and CRF design

Tracked status and progress of data management for allocated projects/trials

Participated in study set-up, validation and implementation of clinical databases

Generated queries and sent for resolution to the investigational site for better quality of the research data

Reviewed clinical trial data to identify missing, incomplete and inconsistent data

Reviewed Clinical research study protocols

Performed discrepancy management (both automatic and manual)

Creating edit check document for given protocol

Developed and executed queries in clinical databases

Represented data management and coordinated with internal/external teams

Generated and reviewed EDC/UAT functionality, comprehensiveness and edit checks

Handling and maintenance of Trial Master File (TMF)

EDUCATION

Bachelor of Pharmacy, Kakatiya University, India

Masters in Computer Science& Information Assurance, Wilmington University, Delaware

REFERENCES

On Request

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