Renu ka King of Prussia, PA ac4aw4@r.postjobfree.com

• Over 7 years of extensive experience in the field of clinical data management

• Excellent analytical and planning capabilities with commitment to achieve clinical data management objectives in timely manner.

• Clinical research professional with thorough knowledge in research study start-up, quality assurance, data review, data analysis, database clean-up and database finalization using clinical data management systems

• Experience in clinical trial phases I-IV

• Proficient in Paper & EDC trials

• Strong and comprehensive CDM skills from study start-up, study conduct, close out and Medical Coding.

• Extensive knowledge of CRF design, Edit checks creation, data cleaning and query process, Lab Data

Reconciliation, SAE Reconciliation.

• Thorough knowledge of Clinical Trial data like Demographic data, Vital Signs, Adverse Events (AE), Serious

Adverse Events (SAE), Laboratory data (LB).

• Experienced in working with CDISC standards. Reviewed mapping specifications, SDTM datasets according to SDTM 3.1.2, developed guidelines for internal validation of SDTM deliverables from vendors.

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

• Proficient with using Electronic Data capture systems like Medidata RAVE and also working knowledge of

SAS.

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

WORK EXPERIENCE

Sr. Clinical Data Manager

- August 2015 to Present

Responsibilities:

• Oversee all DM activities internally, coordinating with the CRO, external vendors.

• Generating the project specific timelines, deliverables and attained with at most quality.

• Reviewing protocol, developing Data Management plan (DMP), Data transfer agreements (DTA), CRF Completion guidelines and other DM specific documents.

• Working as a primary person from CDM in the meetings with Clinical, Safety and Biostatisticians.

• Involving in the training of internal team, CRA's, CRO and vendors based on the project requirements.

• Creating annotated CRF's in compliance with CDASH standards.

• Performing clinical trial data management activities for Phases I to IV.

• Involving in creating Data validation plan including edit checks and Manual listings.

• Performing UAT and QC of data for several trials.

• Interacting with the sites and CRA to coordinate error resolution using data clarification forms.

• Working with external CRO.

• Executing SAE reconciliation and external vendor data reconciliation for several clinical trials.

• Proficient in Medical coding using MedDRA and WHO dictionaries.

• Reviewing frequency listings and performed QC of the data.

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

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

Clinical Data Manager

- November 2012 to August 2015

Responsibilities:

• Involved in writing and reviewing CRF completion guidelines

• Reviewed data management plans and data validation plans

• Performed clinical trial data management activities for Phases I to IV

• Participated in database designs and forms development

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

• Involved in creating Edit check specification and performing UAT.

• Performed QC of data for several trials

• Performed all data cleaning activities for all on-going and start-up studies.

• Assisted in updating Data Management Standard Operating Procedures (SOPs) as needed

• Interacted with the sites and CRA to coordinate error resolution using queries

• Attended meetings with CRO and managed Data Management activities accordingly

• Involved in 3rd party Reconciliation. Attended meetings with Vendors, identified and resolved discrepancies accordingly

• 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

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

Clinical Data Coordinator

- August 2012 to November 2012

Responsibilities

• Reviewed clinical research study protocols

• Developed and documented standards, SOP's, and work practices

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

• Assisted in developing case report forms and CRF completion guidelines

• Assist in training vendors on sponsor implementation of Clinical Trials and Inform and manage vendor activities

• Interacted with other departments to improve the accuracy and quality of data

• Worked on studies in the therapeutic areas of general medicine, oncology, cardiovascular, metabolic disorders, respiratory and central nervous system

• Handled the tasks of maintaining data management project file documentation, finding and reporting the status of data management activities

• Developed and executed queries in clinical databases

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

• Represented data management and coordinated with internal/external teams

Clinical Data Coordinator

- December 2009 to August 2012

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.

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

EDUCATION

Master's in Public Health

SKILLS

Cardiology (Less than 1 year), GCP (2 years), ICH (2 years), reconciliation (7 years), UAT (4 years)

ADDITIONAL INFORMATION Skills

• Data Analysis eCRF design

• UAT Execution Discrepancy Management

• SAE Reconciliation External Vendor Data Reconciliation

• Data Locking 21 CFR part 11

• Inform Medidata Rave

• CDISC ICH-GCP

• ORACLE Clinical DCF (Data Clarification Form) THERAPEUTIC EXPERIENCE:

• Multiple Sclerosis

• Spinal Muscular Atrophy

• Ulcerative Colitis

• Cardiology

• Respiratory Disease

• Neurology

• Oncology

Contact this candidate