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E-mail:

PROFESSIONAL SNAPSHOT:

 A professional with 8 years of qualitative experience in Clinical Data management since 2015.
 Good understanding of FDA and CDISC guidelines, Good Clinical Practice (ICH GCP).
 Knowledge of clinical Trial process from startup-conduct-closeout and Clinical Research Methodology.
 Knowledge of 21 CFR Part 11, Good Clinical Data Management Practice (GCDMP).
 Perform data entry and research in various systems and tracking tools. Apply knowledge of processes and related
systems to assist in identifying, assessing, and resolving issues/problems. Assess and resolve non-standard and
standard issues or problems. Seek advice and escalate issues when faced with tasks/problems outside the scope of
the work.
 A thorough professional with a proactive attitude, capable of thinking in & out of the box. Exceptional
communication, presentations, counseling, and mentoring skills.
WORK EXPERIENCE:

Syneos Health; Bangalore

Senior Clinical Data Associate (Aug 2022 – Present)
 Review clinical trials data in accordance with [Global] Data Management Plans and applicable standardized data
management processes (standard operating procedures, work instructions, et cetera) to identify erroneous,
missing, incomplete, or implausible data.
 Work simultaneously on different projects with varying degrees of complexity.
 Primary point of contact for Non eCRF data, Creating Matrix, and lab specific checks.
 Supports continuous improvement of monitoring processes to deliver quality, consistency, and efficiency in
delivery.
 Conduct data review. Write and resolve data clarifications. Develop and test databases and edit specifications.
 SPOC for the primary trial and a Backup for LDM responsibilities.
 Successfully delivered the data with minimal findings (0.3% error rate), for IA and Final DBL.
 Develop and test databases and edit specifications.
 Discrepancy management in addition to Vendor reconciliation of Labs (central, PK, PD, IG), ECG and data points.
 Liaise with the CTT team to analyze the potential data points thereby facilitating fast data cleaning process.
 Validate data according to CDISC and SDTM output.
 Query management and periodically metrics preparation as per client specifications.
 Preparation and maintenance of metrics projecting progress of study on fortnightly call with customer.
 Created DBL memo, for the recent interim lock and follow up post the snapshot.
 Cascading study updates and other information to keep the mentees up the speed, as a backup plan.
 Applied quality control procedures and checks to ensure data quality standards achieved. Serve as a reviewer of
project documents such as protocols, Case Report Forms (or electronic case report forms), monitoring
conventions, Case Report Forms (electronic case report forms) completion guidelines.
 Proposed efficient ways of performing task.

Glaxosmithkline Pharmaceuticals Limited; Bangalore

Senior Clinical Data Reviewer (April 2021 – Jul2022)
 Work simultaneously on different projects with varying degrees of complexity.

Madhumohan K [email protected] Mobile: +91 9652253137

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 Run ancillary programs (example: diagnostics, 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, et cetera) and aggregate review of
clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, et cetera), and/or
data inconsistencies that require further investigation.
 Apply quality control procedures and checks to ensure data quality standards (client) are achieved. Serve as a
creator/reviewer of project documents such as protocols, Case Report Forms (or electronic case report forms and
electronic diary), monitoring conventions, Case Report Forms (electronic case report forms) completion guidelines.
 Development of [Global] Data Management Plans, Data review plans, Vendor Data transfer specifications (DTS)
and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
 Development of edit check specifications consistent with the clinical data model and case report forms (electronic
case report forms) completion / monitoring conventions and the development and testing of data management
system edit / data validation checks and special listings / procedures/ creation of RPS (report programming
specifications) output used as tools for the data review and discrepancy management activities.
 Interact and collaborate with other project and specialty team members (clinical, programming, statistics, clinical
data management, technical support, drug safety, et cetera) to support the set- up, maintenance, and closure of
the data management aspects of the project to ensure consistent, cohesive data handling and quality.
 Serve as client contact for project meetings and clinical data management status update and potentially support
business development for data management time and cost estimates and prepare and present to potential clients
on global data management capabilities.
 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 and perform
other duties assigned by management.

Covance India Pharmaceutical Services Pvt Ltd; Bangalore

Clinical Data Analyst II (Sep 2018 – Mar2021)
 Managing project timelines and quality of work and providing trainings to the new resources.
 Develop and test databases and edit specifications.
 Discrepancy management in addition to Vendor reconciliation of Lab, ECG and MRI data points
 Validate data according to CDISC and SDTM output.
 Query management and periodically metrics preparation as per client specifications.
 Preparation and maintenance of metrics projecting progress of study on fortnightly call with
customer.
 Assisting in preparing Access Rights forms for EDC database and support team members by creating
forms/memos as required
 Filing of Data Management documentation and data management related administrative tasks as requested,
including maintenance of eTMF as required and Running study status reports.
 Performing Database Lock activities
 Perform Database Decommissioning and create supportive documentation.

Madhumohan K [email protected] Mobile: +91 9652253137

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ICON Clinical Research Pvt. Ltd; Chennai

Clinical Data Coordinator (Dec 2016 - Aug2018)
 Performing as a core resource for the largest, highly expected Therapeutic area ‘Oncology’ in the
organization.
 Reliable back-up to a Data Operations Coordinator of an Onco trial (sister study).
 Conduct data review. Write and resolve data clarifications. Develop and test databases and edit
specifications.
 Validate test steps, Test case creation, development of eCRF to meet the needs of the customer
and the clinical trial utilizing protocol and specifications provided at the pre-design meeting.
 Understand Quintiles EDC processes and the requirements on the design for reporting and study
management.
 Responsible for optimal design reducing the number of edit checks required, ensuring good system
performance, and the utilization of global/client specific libraries to ensure consistency.
 Good communication skills and interpersonal skills, Mentor for two core resources of different
career level.
 Technically sound, logical thinker to resolve questions and issues with the Technical Lead, DTL and
VTL. This role will need to have a good knowledge of forms design, data flow, and the impact of
design on the system.
 Review and reconcile SAE with the GMS safety database vs EDC.
 Dataset validation (DTP) of the RAVE extracts incompatible with SDTM IG v1.3

Quintiles Research India Pvt Ltd; Bangalore

Clinical Data Specialist (Jul 2015 – Dec 2016)

 Accurately review Case Report Form data for completeness, accuracy, and consistency in accordance with
all applicable procedures
 Identify and appropriately address data discrepancies in the clinical data via computerized edit and manual checks.
 Review and resolve auto queries that have fired in the system. Perform manual checks as specified in guidelines
and protocol, issue manual queries and track, review and close all query responses (Query management).
 Perform lab reconciliation on received reconciliation output, issue queries and send vendor issue spreadsheet.
(External data reconciliation in coordination with the vendors).
 Reference data issues log to resolve questions whenever possible.
 Interact with the onshore project leads regarding data validation issues.
 Ensure timelines set by the client in terms of pages produced and clean patient delivery are the key focus.
 Assisting team leaders in resolving complex issues.
 Database lock procedures performed upon confirmation from the onshore PLs, ensured with the thorough checks.
 Create the metrics reports for the deal to ensure the daily assigned task is being accomplished on prioritize wise.
This metrics report also helps us the number of backlogs, the total number of FTEs working on the project also how
many backlogs have missed SLAs.
 Perform complete subject review process to ensure the accuracy of the data.
 Involve in maintenance of study files and other study documents in company specific storage database.
 Perform final database lock activities like Subject review, freezing, locking and casebook locking.

Madhumohan K [email protected] Mobile: +91 9652253137

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THERAPEUTIC
Therapeutic Area
EXPERTISE AND TECHNOLOGYSUMMARY:
Expertise:
 Oncology- Hematologic Malignancies- Leukemia and Myeloma (Phase-III)
 Genito-Urinary: Urinary/Bladder- Incontinence (Phase-III)
 Immune Mediated Inflammatory Disease (IMID)- Systemic IMID: Rheumatoid Arthritis - Phase-III
 Dermatology- Psoriatic Arthritis - Phase II
 Musculoskeletal- Osteoarthritis- Phase III
 Respiratory- Pleural Effusion - Phase I and Pleural Effusion- Phase II
 Vaccines- Pediatric and Adults - Phase II

Data Management Systems experience:

 Medidata RAVE.
 Veeva Vault.
 Inform.

PERSONAL TRAITS

 Skillful in MS Office applications (Excel, Word, Power Point, and Outlook).

 Good knowledge on Clinical Research.
 Familiar with ICH-GCP Guidelines and 21CFR11.
 Optimistic personality disciplined and honest.
 Attentive about learning and adaptive to upgrade.
 Ability to establish and maintain effective working relationships with co-workers and managers.

ACADEMIC CREDENTIALS:

QUALIFICATION UNIVERSITY/BOARD YEAR

Acharya Nagarjuna University College of
M. Pharmacy Pharmaceutical Sciences, Guntur, Andhra 2015
Pradesh

B. Pharmacy Sri Venkateswara College of Pharmacy, RVS 2013

Nagar, Tirupati Rd, Chittoor, Andhra Pradesh

DECLARATION:
Given an opportunity, I have the confidence of discharging any given assignment with utmost diligence and to the
growth of the organization. I hereby declare that the information furnished above is true to the best of my knowledge.

Place : Bengaluru, India

Date : (Madhumohan K)

Madhumohan K [email protected] Mobile: +91 9652253137