Jithesh P M
Associate Manager-CDM
Mumbai
Summary
To set career in a Pharmaceutical / Clinical research organization where my Clinical research experience and overall expertise are privileged for the excellence of organization and for my own development
Overview
17
17
years of professional experience
Work History
Associate Manager Clinical Data Management
IQVIA India private limited
KOCHI
10.2024 - 07.2025
- Served as the Line Manager for the Data Management Team, providing leadership and people management support for approximately 100 staff members across the site.
- Managed all line management responsibilities, including performance management, career development, resource planning, leave management, and employee engagement.
- Conducted random quality reviews and audits to ensure compliance with data management processes, quality standards, and project requirements.
- Supported project delivery by overseeing resource allocation and team performance across diverse therapeutic portfolios.
- Led end-to-end recruitment activities, including candidate screening, interviewing, hiring, onboarding, and workforce planning.
- Oversaw performance appraisal processes and employee development initiatives for a 100-member team.
- Managed the complete employee lifecycle from recruitment and onboarding through performance management and exit formalities.
- Resolved employee administrative and operational issues while ensuring compliance with organizational policies and procedures.
Assistant Manager Clinical Data Management
Symbiance Pharma Solutions
Chennai
04.2023 - 10.2023
- Responsible for providing line management leadership to the Data Management team (CDC/DBA/Other DM functions).
- Managing, training and coaching junior members of the clinical data team.
- Recruiting clinical data members of the team including associates and data managers.
- Participating in appraisals and one-to-one meetings.
- Ensuring all clinical data tasks are completed within budget and are delivered on time.
- Ensures team delivers to expected quality and timelines.
- Handled respiratory studies managed the team of 10 members
Team Lead
Symbiance Pharma Solutions
Chennai
11.2021 - 03.2023
- Participation in departmental project team meetings and resource allocation.
- Delegating study related activities and regular contact/communications with the project manager.
- Proactively participate in internal audits.
- Escalation of quality or compliance issues as and when appropriate.
- Processes to enhance quality of work and quality review.
- Bi-weekly team meeting to discuss timelines among team members and to see the progress of the study.
- There were 2 resources who were reporting to me.
- I was handling 2 studies with resources appropriately assigned based on study requirements.
Clinical Data Coordinator II
ICON Plc Research India Pvt Ltd
Chennai
04.2017 - 10.2021
- Independently perform all data cleaning activities on the assigned projects.
- Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings.
- Independently and accurately generate data queries to resolve data discrepancies.
- Appropriately address responses to data queries and accurately update the clinical data as necessary.
- Coordinate Data Management Quality Reviews.
- Perform SAE, LAB, IVRS, PK reconciliation activities.
- Assist with development and monitoring of study metrics and status.
- Represent Data Management at internal/external meetings as appropriate.
- General understanding of Sponsor contracts with regard to Data Management activities.
- Conduct basic quality control procedures and perform weekly QC.
- Perform prerequisites for project milestones and clean critical variables.
- Lock eCRFs for cleaned subjects in EDC data systems.
- Provide weekly trial status and escalate issues to the attention internal customer (Project manager) and external customers regularly.
- Review data for completeness, accuracy, and consistency.
- Prepare missing pages report for Paper studies and Daily Query status for EDC and Paper studies.
- Provide and complete ad-hoc data listings as and when needed.
- Develop and maintain good communications & working relationships with CDM & CDA teams.
- Trial Master File:
- Managing the eTMF (Electronic Trial Master File) in EDMS (Electronic Document Management System) and GDMS (Global Document Management System) & PTMF (Paper Trail Master File).
- Uploading of study related documents in a sequential basis.
- Sorting out of the missing documents in ELARA\GDMS\DMV, to ensure that the documents are being uploaded in a proper basis.
- Quality Review of the inventory file with that of the EDC database.
- Tracking of missing and inconsistent and quality errors to avoid TMF rejection.
Clinical Data Coordinator I
ICON Plc Research India Pvt Ltd
09.2011 - 03.2017
- Processing of data including case report form, entry and validation of electronic data in accordance with SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements, project management responsibilities as assigned, Query management and discrepancy review, and all data cleaning activities on the assigned projects.
- Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings. Preparation of Study status report to send it to the client on a weekly basis.
- Participated in external team meetings with the client.
- Run Query Detail report and addressing of all answered queries on a daily basis.
- Done Range revalidation, Study Status tracking and maintaining clean patient tracker.
- Reporting and close out activities such as freezing and locking, archiving of all study related documents and participated in project related meetings.
Trainee Junior Data analyst
Cognizant Technology solutions India Pvt Ltd
01.2009 - 01.2011
- Executed data entry in RAVE database, conducted AMOS/MIPS reconciliation, performed user acceptance testing, identified data issues, cleaned data, raised queries, and completed reconciliation and closeout activities.
Education
Master of Science - Zoology
University Of Madras
CHENNAI06-2007
Bachelor of Science - Zoology Vocational
University Of Madras
CHENNAI06-2005
Skills
CDM Tools: Rave 56386 ,Oracle Clinical 453, Inform, Red cap
TMF Tools: PTMF,ELARA,GDMS,ICO-Master
Data bases: Oracle 9i
Timeline
Associate Manager Clinical Data Management
IQVIA India private limited
10.2024 - 07.2025
Assistant Manager Clinical Data Management
Symbiance Pharma Solutions
04.2023 - 10.2023
Team Lead
Symbiance Pharma Solutions
11.2021 - 03.2023
Clinical Data Coordinator II
ICON Plc Research India Pvt Ltd
04.2017 - 10.2021
Clinical Data Coordinator I
ICON Plc Research India Pvt Ltd
09.2011 - 03.2017
Trainee Junior Data analyst
Cognizant Technology solutions India Pvt Ltd
01.2009 - 01.2011
Master of Science - Zoology
University Of Madras
Bachelor of Science - Zoology Vocational
University Of Madras
Disclaimer
I hereby declare that the above-furnished information is true to the best of my knowledge. September 26 -2023. Mumbai