Data Management

Vallu Visrutatma

Ph: 617-***-****

Email: ***********@*******.***

SUMMARY:

Experienced clinical data professional with approximately 6+ years of extensive in Clinical Data Management activities for Phase I- IV Clinical Trials

Broad knowledge of the clinical development process and GCP/GMP/ICH and FDA guidelines

Expertise in EDC systems- Oracle Clinical, Oracle Inform, Central designer and Medidata Rave.

Experience in vendor management activities and communication with sites

Excellent knowledge of R, SAS, SQL query, SQL Plus, XML, Oracle database, and MS Office suite.

Worked in Therapeutic areas like Oncology, Diabetes, orthopedics and cardiovascular.

Coordinated study start-up activities; review and sign off eCRF, eCRF completion guidelines, Data Validation (edit check) Specifications, Data Management plan (DMP), Data review guidelines (DRG), coordinated database live activities, tested/accepted Clinical database for EDC studies.

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

Assist with developing and implementing data management standard operating procedures and in creating written data management plans.

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.

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

Recognized by Senior Department Managers for superior performance and requested by name to support other departments with tight deadlines.

Received Award of Excellence for identifying critical discrepancies in the database that supported company's FDA submission for drug approval.

Key member of a data quality improvement team that reduced data errors by 70%.

Assigned by senior management to Project Initiation Group based on expertise in database design, report testing and database validation.

Technical Skills

EDC Databases: Oracle Inform, Oracle Clinical, Clindex EDC BioClinica electronic data capture system-Express 4.1, Medidata Rave.

Reporting Tools: TOAD, Business Objects, Spotfire, Clintrial 4.3, Redcap, CRIS, J-Review, I-Review, BOXI, IVRS.

Operating systems: Windows 7/XP, MS Office (Word, Excel, Outlook, PowerPoint)

SAS Programming: Base SAS, SQL, SAS Macros

Database: Medidata Rave

MS Office: Word, Excel, Power Point, Access, and Outlook

PROFESSIONAL EXPERIENCE:

Acorda Therapeutics, Ardsley,NY Oct 2016 -June 2017

Clinical Data Manager

Expertise working with Oracle Clinical.

Experienced in creation of DMP (Data Management Plan) and Edit Checks Specifications, Edit Checks Testing and Validation for both Paper and EDC studies for multiple protocols simultaneously.

Responsible for creation of data management plans and other data management documentation as needed

Responsible for Supporting and executing the validation and testing procedures of clinical database, eCRF and edit checks.

Responsible for CRF design, review and validation of clinical database, including supporting management of CRO activities.

Performed quality control individually and quality assurance tasks on all projects responsible for as well as when requested.

Helped in designing the databases and required forms necessary for the entry and report of clinical data.

Responsible for monitor and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines

Responsible for participating in ongoing data review throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management for the life of a project.

Supported the creation and maintenance of all essential data management documentation, Data Review Guidelines, CRF Completion Guidelines, Data Entry Guidelines, and other study specific work instructions or guidelines for assigned projects to ensure compliance to quality system

Compiled and validated data. Develop and initiate more efficient data collection procedures.

Responsible for protocol review, designing the CRF as per the protocol, generation CRF completion guidelines/CCI's that are to be utilized by the sites

Responsible for CRF/database design and implementation, including specifications, testing and reproduction

Training with requirements as per the ICH-GCP guidelines in clinical research; Monitoring clinical research; Ensuring patient safety and data integrity; Data collection; Preparation of reports.

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

Developed and extracted patient clinical data reports for publications and presentations

Responsible for Generating site queries for missing information and communicating with site personnel to resolve both internal and external queries

Responsible for Collecting data, and identifying errors and inconsistencies in CRF data, and ensuring their resolution

Interpret data from primary and secondary sources using statistical techniques and provide ongoing reports.

Shire Pharmaceutical, Exton, PA Jan 2016-Sep 2016

Clinical Data Manager

Expertise working with Medidata RAVE.

Support the Lead Data Manager by performing activities such as CRF design, database design and Data Validation Manual creation

Perform initial review of Clinical Trial Data

Provided assistance in protocol review and eCRF design for newly conceived trials.

Reviewed and approved clinical database specifications, study set-up documentation, SDTM eCRFs, CDISC and mapping documents. Oversaw the set-up of non-CRF data transfers.

Participated in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis).

Developed Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.

Developed database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.

Lead EDC database (DB) specification process.

Developed Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.

Reconciled electronic data transfers from vendor to Sponsor.

Developed test scripts and execution logs for User Acceptance Testing (UAT). Reviewed clinical research study protocols.

Executed projects and completed oversight of clinical trial data. Ensured documentation according to agreed timelines and quality expectations.

Worked with database developers in designing the database, data model, testing and implementation of the study databases.

Reviewed and tested the EDC functionality and validation procedures.

Worked on SAE and Lab reconciliation.

Performed soft lock and hard lock of the database at the completion of the study after thorough QC of data.

Florida Institute of Technology, Florida. May 2014 - Dec 2015

Clinical Data Manager

Defined edit checks for the study/project.

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.

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.

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.

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

SAE and External Data:

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

Performed reconciliation of Serious Adverse Events.

Quality Control Activities:

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

Freezing the database.

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

Close Out:

Creation and maintenance of study files and other documentation.

Miscellaneous

Performed conduct activities on about 15 studies.

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.

Contributed to design and development of new GUIs, validation components and reporting tools.

Quintiles, Banglore, India (CRO) Jan 2012- Dec 2013

Clinical Data Coordinator

Collected, reviewed and maintained regulatory documents and performed IRB submissions

Assisted in the development of protocols, case report forms, informed consent forms, and IRB materials

Monitored data expeditiously to reduce data discrepancies; collaborated with both the sites and data

Increased network practitioner recruitment rate by nearly 150%

Interpret data from primary and secondary sources using statistical techniques and provide ongoing reports.

Compile and validate data. Develop and initiate more efficient data collection procedures.

Performed detailed research and data collection from multiple databases to identify and extract useful information.

Performed strategies for selection, audit, approval, and qualification of vendors based on the service/product being delivered.

Worked on methods and tools used to accomplish a vendor pre-qualification and ongoing qualification.

Conducted risk assessment strategies to determine the timing, method, and nature of audits.

Ensures all processes are compliant with SOPs and GCP guidelines.

Responsible to Generate data queries based on validation checks or errors and omissions identified during data entry to resolve identified problems

Assisted in Process clinical data including receipt, entry, verification, or filing of information

Coordinated data updates between sites, local labs, and external vendors

Responsible for complete and accurate data entry using EDC before data point cut offs

Performed QC of Source Date to ensure adherence to protocol, GCP and internal SOPs

Assisted study team in verifying patient eligibility

Maintained multiple tracking spreadsheets to monitor the progress of assigned clinical trials

Involved in Quality control of the trial data against all CRFs

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

Generated and resolved queries via Oracle clinical and INFORM

Supported the data base locking activities after getting the approvals

EDUCATION

Masters in Information Technology Management – Webster University – Orlando, Florida

Bachelors in Biotechnology- Jawaharlal Nehru Technological University- Hyderabad, India

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