Rajalakshmi Umesh

Associate Lead Data Manager, Clinical Data Management (Bangalore, India)

Employment History

Covance Inc., Bangalore, Karnataka/India – May. 2021 – Present

Associate Lead Data Manager – May. 2021- Present

•Data management lead on 2 projects. Developed and implemented Data Management Plan, systems set-up, data accession, data entry and data review specifications and processes within timelines and budgets.

•Delivering Excellence: Takes leadership role in project implementation

•Provides Data Management expertise to the team in identifying opportunities for process and budgetary optimization

•Ensures Data Management are delivering quality data and documentation on time, on budget and to Shire’s quality standards and SOPs

•Reviews Data Management performance measures and evaluates cost/benefit of actions taken to remedy or improve performance

•Collaboration with study team members to identify and resolve issues impacting goal attainment

•Judgment and Decision Making: Evaluates immediate business impact and takes decisive action

•Provides within and between study comparisons of DM timelines for assigned projects. Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve.

•Manages data management personnel including hiring, performance management, training, and resource allocations

•Direct team members in daily activities including training and supervising Clinical Data Managers I and II

•Works with team members via matrix relationships by directing work, resolving problems and/or providing guidance

•Be responsible for identification of data handling processes for non-CRF data, including lab data and image handling

•Lead Case Report Form Design according to the protocol with all Study Team members using established standards

•Responsible for ensuring the integrity of data and providing recommendations for corrective action when necessary

•Liaise with Biostatisticians regarding data validation and lock of the database, including management of discrepancies.

•Managed clinical data vendors utilizing strategic communication skills that increased productivity, quality and punctual delivery of projects.

•Developed and maintained close liaison with project client contacts, core team members and Project Managers.

•Performed date review, validation, query development and resolution.

•Implemented and maintained data auditing reports, metrics and tracking reports.

•Reviewed and revised all documents for Trial Master File.

•Conducted all database release activities.

•Computer skills include Phase Forward, inform, Oracle Clinical, CIWS, I-review, ClinTrial, Dictionary Coding, QRMS, SQL, CRAMS, IDX, UNIX, Microsoft Office XP.

Covance Inc., Bangalore, Karnataka/India – Oct. 2018 – Apr. 2021

Assistant Clinical Data Manager – Oct. 2018 - Apr 2021

•Working currently as Backup Lead Data Manager performing all Task Matrix related activities including but not limited to upload and download of vendor data, liaising with programmers to run SAS checks at definite interval, liaising with all stakeholders for issue resolution, providing metrics data, allocation of work to the team globally, updating DM Dash board with current Study status, SAE reconciliation and oversight of other vendor reconciliations, adjudication of subjects for patient profile, generation of PDFs for decommissioning, QC of eCRF PDF for decommissioning, uploading of documents to eTMF etc.

•Currently playing a role of Associate Data Manager by performing activities including all Data management end to end activities like supporting lead in study start up activities- eCRF Design,

ECS Development, tSDV setup, EDC integration with IXRS system and change controls, drafting SAE Recon plan, drafting Vendor Data Plan, drafting DMP, DRP and DRP Matrix, in Post EDC set up activities independently leading for setting up Data Cleaning Tools for SAS checks of Vendors, Protocol deviations, SAE Reconciliations also liase and coordinating with SAS programmers and Validation team and also coordinating with Data review team to oversee the ongoing Data cleaning activities, SAE and Vendor Reconciliations and follow up with Clinical/vendor for any outstanding issues until resolution, timely conduct Internal study team meetings and focus on data cleaning quality so that will maintain the overall good health of the study during any upcoming deliverable, proactively identify and mitigate the Risks.

•Have worked in Startup and supported Lead for phase l study and performed activities like provided input on the eCRF screen design per the protocol, Led Screen Review Meeting that is EDC demonstration to client, aligned all activities with Covance SOP’s and templates, reviewed drafted DMP, ECS, Critical data definitions form and shared inputs with LDM and supported LDM on all start activities.

•Have worked in Startup and supported Lead for phase lll study like provided input on the eCRF screen design per the protocol, aligned all activities with Covance SOP’s and templates, drafted DMP, reviewed ECS, drafted DRP and DRP Matrix, drafted SAE Recon plan, drafted Vendor Data plan, drafted Coding specification, review Critical Data Review, drafted the tSDV test scripts and reviewed tSDV specifications, drafted eCCG’s, performed DM UAT of screens and reviewed eCRF specifications for consistency, also performed the DMUAT for EDC integration with IXRS, reviewed ECS and provided inputs on ECS per protocol, coordinated and follow up’s with cross functional team EDC designer, clinical team, Stats team and Lead data manager for all activities to be in line with agreed timelines. For this study and other phase l study currently working as Back up Lead

Data Manager performed Post EDC set up activities like setup of EDC Data cleaning tools that is SAS checks for PD, SAE, CCLS and Manual review SAS EDC checks, currently working on IXRS SAS checks to bring to production for this study.

•Have worked in Startup and supported Lead for Covid 19 study like provided input on the eCRF screen design per the protocol, aligned all activities with Covance SOP’s and templates, drafted DMP, reviewed ECS, drafted DRP and DRP Matrix, drafted SAE Recon plan, drafted Vendor Data plan, drafted Coding specification, review Critical Data Review, drafted eCCG’s, performed DM UAT of screens and reviewed eCRF specifications for consistency, reviewed ECS and provided inputs on ECS per protocol, coordinated and follow up’s with cross functional team eDC designer, clinical team, Stats team and Lead data manager for all activities to be in line with agreed timelines. For this study currently working as Back up Lead Data Manger and have performed 2 Change controls performed and took a Lead in DMUAT.

•Review clinical trials data in accordance with [Global] Data Management Plans and applicable standardized data management processes (Standard Operating Procedures, Work Instructions) to identify erroneous, missing, incomplete, or implausible data and run ancillary programs (like special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.

•Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database.

•Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application.

•Perform reconciliation of the clinical and safety databases, reconciliation of central laboratory and/or third-party vendor data (Electronic Case Report Form, Electronic Diary, specialty laboratory) and aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance) and/or data inconsistencies that require further investigation.

•Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved.

•Serve as a reviewer of project documents such as protocols, Case Report Forms (or Electronic Case Report Form and Electronic Diary), monitoring conventions, Electronic Case Report Form and Electronic Diary completion guidelines.

•Assist with the development of [Global] Data Management Plans and Quality Management. Plans that will deliver accurate, timely, consistent, and quality clinical data.

•Assist in the development of the clinical data model and/or database design and annotate the Case

Report Form (Electronic Case Report) according to these specifications, the creation of data acquisition conventions and data review guidelines / edit check specifications consistent with the clinical data model, [statistical] analysis plans, and Case Report Form completion / monitoring conventions and the development and testing of Data Management system edit / data validation checks and special listings / procedures used as tools for the data review and discrepancy management activities.

•Closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.

•Support the training of project staff on project-specific, global, standardized Data Management processes; maintain technical data management competencies via participation in internal and external training seminars and review literature and research technologies / procedures for improving global data management practices.

Pharmaceutical Product Development, Bangalore, India – Jul. 2017 – Oct. 2018

Clinical Data Associate II – Jul. 2017 – Oct. 2018

•Served as a Lead Clinical Data Associate for 2 protocols of different therapeutic area and as a mentor/trainer for new and less experienced Clinical Data Associates to assist with general and study specific issues.

•Review Coding, Sponsor and Medical Monitor queries and maintain tracker to document the changes.

•Performed third party vendor reconciliation (Pharmacokinetics, Biomarkers, Human Immunodeficiency Virus Ribonucleic acid, Laboratory)

•Creates weekly status report (Metrics, Clean Patient Tracker and Missing Pages Report) and sends them across to the team.

•Assisted Study Leads in Updating Data Validation Manual and Electronic Case Report Form guidelines as per the trials protocol and design, Validated the Missing pages’ report in accordance to the specifications created.

•Performed user acceptance testing and Data Validation checks and also worked on database modifications due to protocol amendments or edit check updates.

•Generated Patient Data Report generation team and assisted with archival team for various protocols.

•Interact and collaborate with other project and specialty team members (clinical, programming, statistics, clinical data management technical support, drug safety)

•Have High Potential to lead the study- performed Co-Lead activities, aligned with Standard Operating Procedures as required to maintain the overall health of the study.

•Also worked on overall development of Existing Process-Process enhancement and provided/shared ideas with team, create forum for healthy discussion- like scheduling Knowledge Sharing Sessions and shared with senior management, about bringing new Tools for better review and ease Data Management review.

Quintiles IMS, Bangalore, Karnataka/India – Oct. 2014 – Jul. 2017

Senior Medical Data Reviewer – Apr. 2016 – Jul. 2017

•Completed check on quality of the deliverables, was identified to perform quality control for cross functional studies.

•Ensured timelines set by the client in terms of pages produced and clean patient delivery are the key focus. Ensured the completeness and validity of the clinical trial data that has been entered in database.

•Performed quality control and user acceptance testing procedures for visualizations and platform used for reviewing.

•Created the metrics reports for the deal to ensure the daily assigned task is being accomplished on prioritize wise.

•Performed role of Subject Matter Expert for Inform data base.

•Attended kick-off meetings, weekly team meetings, and client meetings, as needed or requested.

•Hands on experience with Excel, preparing user acceptance testing for visualizations and other process related activities and also sending study metrics to team members and follow up for all pending issues and tasks to complete before set timelines with good quality.

•Reviewed any other information as necessary to determine overall readiness of the patient information for next level review.

Medical Data Reviewer – Oct. 2015 – Apr. 2016

•Reviewed and resolved queries. Performed manual checks as specified in guidelines and protocol, issue manual queries and track, review and close all query responses (query management).

•Reviewed all inclusion and exclusion criteria to ensure each patient met minimum level of acceptance into the clinical trial.

•Reviewed all reported adverse event, concomitant medication and medical history information to ensure all supporting information was expected and/or implausible data was verified and adherence to protocol expectations and its impact on other patient reported/observed information.

•Reviewed all laboratory results to ensure completeness of information and adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the adverse event information for the patient.

•Reviewed any other information as necessary to determine overall readiness of the patient information for next level review.

•Interacted with other Medical Review staff to verify information and/or triage new data issues or prior identified action items.

•Performing Data Management activities and achieved four major milestones.

Indegene Life systems Pvt Ltd, Bangalore, Karnataka/India – Apr. 2013 – Sep. 2014

Clinical Trial Analyst – Apr. 2013 – Sep. 2014

•Review of clinical trial protocols from Clinical trials.gov, EudraCT and updated appropriate information in trial database, product used by client for trial details information sources.

•Reviewed and updated latest results from authenticated articles.

•Worked on adhoc client requirements for different clinical trial reports as required.

•Trained new hires, for easy on boarding and mentoring.

•Quality control activities.

Vishal Dental Clinic, Bangalore, Karnataka/India – Apr. 2012 – Mar. 2013

Dentist – Apr. 2012 – Mar. 2013

•Patient consultation and provided dental treatment appropriately.

Therapeutic Experience

•Other: Non-Inflammatory, noninfectious Respiratory, Cystic Fibrosis (phase lll)

•CardioMetabolic: Cardiovascular Disease, Type II Diabetes, Acute Coronary Syndrome

(ACS), Acute Myocardial Infarction (phase lll)

•Oncology: Solid Tumors, Breast, Colorectal, Lung Cancer (Small and Non-Small Cell Lung

Cancer), Prostate, Hematologic Malignancies, Leukemia, Hodgkins or non-Hodgkins

Lymphoma (phase I, phase II & phase II)

Language Capabilities

•English

•Kannada

•Telugu

•Tamil

•Hindi

Education

• Bachelor of Dental Sciences, Rajarajeswari Dental College & Hospital, Bangalore, Karnataka, India

SKILLS

•Ability to attain, maintain and apply a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures

•Knowledge or ability to rapidly gain knowledge with programming/query languages

•Ability to attain, maintain and apply a working knowledge of GCPs and applicable SOPs

•Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations

•Ability to prioritize activities and consistently meets deadlines according to accepted levels of quality, paying attention to details

•Ability to prioritize and to adapt quickly to changing business conditions plus a “can-do” attitude

•Logical thinking, attention to detail, good organizational skills, and problem-solving abilities

•Understanding the principles of clinical research, GCP (Good Clinical Practice), and GCDMP (Good Clinical Data Management Practices)

•Good communication skills with the ability to communicate with both the technical and business areas

•Excellent problem solving skills and ability to think creatively

Memberships/Awards

•IQVIA Applause Award 2015

•IQVIA Bravo Award 2016

•IQVIA Triumph Award 2017

•Covance ACE LEVEL 1,2,3 Awards 2018-2021

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