Data Management

Madhu CR

Sr. Clinical Data Manager King of Prussia, PA **********@*****.***

• A dedicated clinical data manager professional with an overall of 7+ years of comprehensive data management expertise.

• Sound knowledge and commitment of adherence to ICH-GCP, CDASH/CDISC, FDA, and 21 CFR Part 11.

• Having good work experience in CDM skills from Study Start-up, Study Conduct and Study Close out activities.

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

• Experienced in working on various EDC databases like Oracle Clinical, Rave and Inform.

• Responsible for huge number of studies in clinical data management including Database Design, Edit Checks, Data

Clarification Form, Data Management Plans, Time lines and Budgets.

• Good working knowledge in SAS and experienced in working with CDISC standards while reviewing the mapping specifications according to SDTM 3.1.2 guidelines.

• Good work experience in designing the CRFs, Data Validation Specifications, Vendor Data Reconciliation, SAE Reconciliation, Edit checks creations, Data cleaning and Query process for assigned studies.

• Having good experience in creating and gathering the required documents like DMP, DTA, CCI, DVS, SDR.

• Good working Experience in creating the SDR to design the database according to the unique CRFs.

• Have good working exposure to different phases of trials from Phase I- Phase-IV clinical trials and experience in managing start to end EDC trials

• Worked on Query management, offline listings, Protocol reviews, Database locks, Database freeze, UAT edit checks, Test cases creation and validation of edit checks.

• Having good experience in handling TMF

• Good Knowledge on RECIST.

• Experienced in working with discrepancy management issues within a data during the specific study.

• Having good coordination and interaction with clients, vendors and team in a different departments of clinical research domain.

• Provide logistical support to study team and forecast trial specific milestones, identify potential issues and

implement possibility plans to specific study team.

Work Experience

Sr. Clinical Data Manager

November 2015 to Present

• Actively participated in all areas of clinical data management including study start up, study conduct, study lock

• Led and participated in a focus team or global or local standard methodology teams,

• Monitored the team work and meetings.

• Developed clinical study data specifications, including CRF design, user requirements, edit rules/checks and query logic

• Worked with databases Medidata Rave, Oracle Clinical and Phase Forward Inform

• Knowledge in CDISC, CDASH, 21 CFR Part 11 guidelines.

• Provided clinical data management support for study operations and analysis groups

• Assisted in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit

• Experienced with validation of EDC systems from a study level. Should have experience creating study requirements, test cases, and UAT documentation.

• Experience in clinical data transfers between systems and creation of Data Transfer Agreements (DTAs) between external data sources

• Ensured completeness, correctness and consistency of clinical data and data structure across all projects.

• Participated in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM. Participated in CDM and cross functional initiative teams. Project level coordination of CDM tasks, while demonstrating knowledge of hands-on work.

• Communicated with functional peers regarding project status and issues and ensure project team goals are met.

• Provided guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.

• Worked in the therapeutic areas of Oncology, Chronic kidney disease, Respiratory and Antiviral, anti-microbials

Clinical Data Manager

EDC SOPs

September 2013 to November 2015

• Overseeing company's studies performed database cleanup

• Performed CRF design and reports design, edit checks writing, EDC SOPs writing

• Worked with databases Medidata Rave, Oracle Clinical

• Well known CDISC, CDASH, 21 CFR Part 11 guidelines.

• Worked with statistics team to develop statistical plan based on CRF design and data management plan

• Involved in data management plan and data transfer plan writing (DTA)

• Knowledge in discrepancy management and reports generation

• Ongoing reviewed of electronic CRF, generation of queries, closing of queries

• Communicated with medical monitor & pharmacovigilance department for resolution of site open safety issues and with site CRAs for resolution of site open issues

• Worked on UAT testing and reconciliation process of clinical database

• Generation and maintenance of data management related documentation

• Participated as the primary data management representative on multidisciplinary project teams and ensure effective communication exchange

Clinical Data Coordinator

August 2011 to September 2013

• Involved in managing Rescue Study activities for the client that involved in identifying and resolving challenges and bottlenecks.

• Involved in previewing and assessing all study elements to regain lost time and momentum.

• Identified keys issues preventing study success and resolving them to get study back on track.

• Performed SAE Reconciliation and LAB/Vendor data Reconciliation.

• Familiar with ClinPlus platform in order to perform data management activities and managing eTMF.

• Assisted SAS teams in reconciliation process using several SAS commands.

• Performed UAT for effective functioning of eCRF in EDC system using SQL queries.

• Performed Quality Control for all the activities throughout the entire CDM process to attain high quality and standardized data.

• Developed test scripts/query tests for each CRF fields and performed User Acceptance Test (UAT) to ensure its accuracy and effective functioning.

• Identified discrepancies in the clinical data sets pertaining to each CRF via computerized edits and manual checks/

listings.

• Generated data queries based on validation checks or errors identified during data entry process thereby improving inconsistencies and inefficiencies in processes.

• Performed Discrepancy Management including manual and system query generation, by sending queries to the sites, reviewing and closing the answered queries.

Clinical Data Coordinator

July 2009 to August 2011

• Appraised clinical research study protocols

• Set and managed project timelines, developed case report forms.

• Reviewed paper CRF and eCRF data, worked with CRO in designing the CRFs and clinical database and CRF

completion guidelines.

• Worked with coding using auto encoder including MedDRA and WHOdrug

• Communicated with database developers in designing the database, data model, testing, implementation of the study database.

• Generated and managed queries.

• Designed, processed the DCF and updated the datasheets.

• Tested UAT including edit checks, role testing and folder dynamics.

• Worked on SAE and lab reconciliation

• Functioned soft lock and hard lock of the database

• Implemented and maintained standard operating procedures and audit policies.

Skills

DATABASE (4 years), ORACLE (4 years), SAS (2 years), Serial Attached SCSI (2 years), SQL (2 years)

Additional Information

TECHNICAL SKILLS

Database / EDC Systems - Medidata Rave, Oracle Inform, Oracle Clinical, ClinPlus

Applications - MS Office Word, Excel, PowerPoint, Access, Outlook, Project Planner, JIRA, WebEx, J-Review

Programming - SQL, SAS, R Programming, Java, JavaScript, C++, HTML, CSS

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