Data Management Clinical

Neelima Bisen

Harlingen, Texas / USA +1-956-***-**** **************@*****.*** www.linkedin.com/in/dr-neelima-bisen-aa1796162

SUMMARY

Clinical Data Manager with 8 years of experience in overseeing data management activities for clinical trials, ensuring data integrity, compliance, and accuracy. Proficient in utilizing advanced data management software, developing and implementing data management plans, and collaborating with cross-functional teams. Demonstrated ability to streamline processes, enhance data quality, and support regulatory submissions

TECHANICAL EXPERIENCE

Clinical Data Management Systems (CDMS): Medidata Rave, Oracle Clinical, Inform

Data Management Plan (DMP) development and implementation

Data cleaning, validation, and reconciliation

CRF (Case Report Form) design and development

Data analysis tools: SAS, SQL

CDISC standards: SDTM, ADaM

Regulatory compliance: GCP, ICH guidelines, FDA, EMA regulations

Project management and timeline adherence

Microsoft Office Suite (Excel, Word, PowerPoint)

Project management tools: JIRA, MS Project

Risk-Based Monitoring strategies

Medical Data Review and Quality Control

Protocol development and amendments

Database design and maintenance

Adverse Event (AE) and Serious Adverse Event (SAE) reporting

Visualization Tools: Experienced in TIBCO Spotfire Data Visualization and Analytics, CDW (Clinical Data Warehouse), elluminate platform.

Document Management Systems: Proficient in eTMF, Veeva Vault

PROFESSIONAL EXPERIENCE

Accenture Solutions Hyderabad/India

Protocol Data Manager DEC2021-Present

Provide insights into study start-up activities, including timelines, and collaborate to allocate study resources as required.

Review and offer feedback on the stable draft protocol, ensuring regular updates to the study team regarding study start-up activities. Schedule and conduct regular meetings, including Interactive Review Meetings, to discuss study activities.

Develop a comprehensive Data Management Plan encompassing specific data cleaning list, understand the responsibilities, and provide necessary input to the client. Coordinate with other stakeholders to gather inputs on listing specifications and provide feedback to the clients.

Performing the Quality Control ( QC) of the work done by the team on monthly basis or as and when required.

Responsible for the review, development and/or writing of clinical trial documents and manuals, including but not limited to Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans and eCRF Completion Guidelines

Generate various documents during the study set-up phase (e.g., procedure/edit checks, database specifications, dynamic metrics specifications) as applicable. Draft technical specifications for programming reports as needed and applicable.

Collaborate with the database developer team, as well as the build and testing teams, to support Data Management and Study Start-Up (DMSSU) activities, including overall eCRF build, programming, UAT of edit checks, and UAT testing of eCRF as necessary and applicable. Conduct testing of integration configurations (e.g., Safety Gateway) as applicable.

Develop eCRF instructions and prepare for eCRF training if required. Address queries regarding the protocol, CRF, or procedure/edit check specifications, escalating them to the client for further clarification if necessary.

Manage the upload and approval of pre-deployment documentation to eTMF. Ensure post-deployment documentation is uploaded to eTMF. Handle user access requests, reviews, revocations, and run user access reports throughout the study duration, as necessary and applicable.

Track study execution activities against the schedule defined in the Data Management Plan (DMP) using Rave reports/CDW reports. Provide regular progress updates to clients through meetings or email. Monitor Data Review Acknowledgement (DRA) reports from the eTMF reports tab to ensure data review acknowledgement from all applicable stakeholders during conduct and lock phases.

Coordinate with the team to oversee BICR transfer, external data transfer, and reconciliation. Support subject data transfer activities and inform stakeholders accordingly. Review the GBS query spreadsheet and collaborate with the client to clarify if needed.

Review query metrics and assist with migration activities for Rave or Oracle studies. Review study DB lock timelines and provide input to the client on study lock activities and timelines. Attend study lock meetings to provide updates on activities. Track study lock activities against the DB lock timelines using RAVE reports or CDW reports for Rave studies. Provide regular progress updates to clients through meetings or email.

Providing data review training and guidance to team members that are supporting their trial(s).

Request a database snapshot or data extract. Lock forms in Rave on an ongoing basis or as needed in accordance with log timelines; also, re-lock or unlock forms if necessary. Monitor missing pages, pending Source Data Verification (SDV), and pending Principal Investigator (PI) signatures of assigned investigative sites/clinical studies via various applicable reports. Track and follow up with site-facing roles via Data Management Letters (DMLs) to ensure data entry is completed by sites and all critical missing eCRFs are completed at the time of lock.

IQVIA Bengaluru /India

Senior Medical Data Reviewer AUG 2015-DEC 2021

Independently managed Study Start-Up to Close-Out processes, including involvement in Data Management Planning (DMP) tools and conducting Spotfire User Acceptance Testing (UAT), contributing to study documentations.

Identified anomalies in patient-reported data requiring further investigation with clinical sites to ensure overall accuracy.

Verified clinical trial data for medical and other discrepancies, issuing queries to sites accordingly.

Acted as Point of Contact for multiple projects spanning various therapeutic areas.

Provided project management expertise, collaborating with clinical study teams, key decision-makers, and internal members to drive continuous process improvements, escalate issues, project workload projections, and offer technical guidance with minimal supervision.

Fostered strong customer relationships, tracked service performance, identified root causes of issues, and implemented remedial actions under guidance.

Ensured timely resolution of compliance issues and consistently sought opportunities to enhance task efficiency and deliverable quality.

Conducted therapeutic area/indication training for project clinical teams and prepared training materials for data management activities.

Participated in Kick-Off meetings, weekly team meetings, and client meetings as required.

Performed data analytics as a Clinical Data Scientist, reviewing visualizations to identify potential issues of concern.

Served as a Subject-Level Data Reviewer (SLDR), identifying patient anomalies through Subject-Level Data Review to ensure medical congruence/plausibility of subject data per protocol.

Reviewed study status information for data flow reports and initiated appropriate actions.

Sai Hospital Pune/India

Clinical System Analyst NOV 2013- Aug 2015

Led the implementation of a new electronic health record (EHR) system across multiple departments, coordinating with clinical staff, IT teams, and external vendors to ensure a smooth transition and minimal disruption to workflow.

Conducted extensive workflow analysis to identify inefficiencies and opportunities for improvement within clinical documentation, order entry, and medication management processes.

Configured and customized the EHR system to meet the specific needs of each clinical department, including building templates, order sets, and decision support rules.

Developed and delivered comprehensive training programs for clinical staff on EHR usage, providing ongoing support and troubleshooting to ensure user proficiency and satisfaction.

Collaborated with interdisciplinary teams to design and implement clinical decision support alerts and reminders, improving patient safety and adherence to evidence-based guidelines.

Managed system upgrades and enhancements, coordinating testing, validation, and deployment activities to minimize downtime and ensure system reliability.

Generated and analyzed clinical data reports to support quality.

EDUCATION & OTHER

B.A.M.S. [Bachelor of Ayurvedic Medicine and Surgery], Graduated in NOV 2007

UNIVERSITY : MUHS (MAHARASHTRA UNIVERSITY OF HEALTH SCIENCES, NASHIK)

COLLEGE: Smt.K.G.M.P. Ayurvedic College, Mumbai INDIA

LANGUAGES: English, Hindi and Marathi

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