Ravi Kumar PMP®
Hyderabad
Summary
To work in a globally competitive environment on challenging assignments where I can explore and enhance my skills and knowledge in a highly motivated, progressive, and friendly environment that dynamically works towards professional growth and development.
I am an M. Pharmcy-Pharmacology postgraduate from B.P.U.T university (affiliated), Rourke with 11.2 years of experience in clinical research organization as clinical data manager, with extensive skills And passion to expertise in clinical data analysis, data validation And risk management planning. And good team player with strong written and verbal communication skills.
Overview
11
11
years of professional experience
7
7
years of post-secondary education
2
2
Certifications
Work History
Team Manager
Cognizant
Mumbai
3 2022 - Current
- Working as a Project Data Manager and lead the data management activities throughout the life cycle of a clinical trial, from the study conduct and closed out activities
- Involved in set-up activities like Edit check specifications, eCRF completion guidelines and DMP creation
- Preparation of HOS deck and present with study team in monthly HOS meetings
- Supporting Program lead to keep studies on track
- Review applicable Clinical team query spreadsheet, listing review and work with Data Management team to resolve issues and escalate to Client
- Clarifying the doubts in the studies to the DMs working in the study
- Involved in study Archival activities post DB Lock
- Ensure that staff has the proper materials, systems access and training to complete job responsibilities
- Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff
- Ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by Management.
Assoc Clin Data Mgmt
IQVIA
Hyderabad
04.2021 - 03.2022
- Proactively communicating with Trial Data Manager
- Involved in all set-up activities including functional QC of eCRF's, DVS writing, Offline listing specs writing, CCG writing, developing DMP
- Performed SAE reconciliation, all third-party vendor data reconciliation including central lab, PK, Biomarker, ECG and IVRS reconciliation.
Team Leader
Accenture
Hyderabad
10.2018 - 04.2021
- Training & Mentoring for junior associates and an appropriate resource allocation for studies
- Created the Edit check specification, performed the UAT for Go-live study
- Performed the Screen UAT and UAT of Edit checks
- Perform Data Review & Discrepancy management activities such as query generation – resolution and Manual Checks
- Managing listing review activities for the allocated studies
- Responsible for weekly study call with respective study team to provide study updates
- Managed timelines and coordinate data management activities for assigned protocols
- Communication with Study team, attend and conduct relevant study teleconference meetings with Client staff
- External data handling, data reconciliation and Communication with vendors
- Worked for the close out studies as per the Database lock checklist
- Performed Freezing and Locking of the subject.
Clinical Data Coordinator
ICON clinical research
Chennai
01.2017 - 10.2018
- Serve as a member of the project team with primary responsibility for clinical data review, Data Transfers and reconciliation activities to support the delivery of clinical data
- Performed Data Review & Discrepancy management activities such as query generation resolution and Manual Checks (EDC trials)
- External data handling, data reconciliation and Communication with vendors
- Review, analyze, and validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines
- Follow up on outstanding queries for all active studies with the Site monitors located in different parts of the world
- Create and maintain study files and other appropriate study documentation
- Ensure timelines set by the client in terms of discrepancies resolved and clean patient delivery are met.
Clinical Data Analyst
PAREXEL International India Pvt Ltd.
Hyderabad
09.2014 - 01.2017
- Understand the data management requirements of the clinical trial protocol in order to perform Data analysis tasks
- Performed all third-party Data Reconciliations (Central Labs, ECG, PK-Pharmacokinetic data, PD-Protocol deviation data)
- Performed SAE reconciliation using Safety database (ARGUS) and Clinical database and regular follow up with associates of Safety database, preparation of Safety Data Amendment
- Performed other data management tasks like query management, data listing review
- Performed data validation, final inspection and QC procedures
- Experience in startup activities, test data creation, UAT testing
- Sending the weekly, monthly metrics to data team leads and study managers
- Training & Mentoring for junior associates and an appropriate resource allocation for studies
- Independently bring project solutions to the data analyst team
- Attend both client and team meetings when needed
- Develop and maintain good communications and working relationships with CDM team.
Clinical Data Analyst
Roxaane Research
Chennai
05.2013 - 09.2014
- Performing Data Entry, Data Validation like Discrepancy Management, Query management
- Generate queries and clarifications to clarify and improve the quality of the data
- Updating database with query resolutions
- Involved in Preparation of Clean and Dirty Patient Data, and User Acceptance Testing
- Responsible for certain aspects of data management process for assigned project
- Clean Patient Tracker, CRF Tracking, Assigning Patient in OC
- SAE reconciliation.
Education
Master of Pharmacy - Pharmacology
Royal College of Pharmacy
Odisha 05.2010 - 07.2012
Bachelor of Pharmacy - Pharmacy
Ultra College of Pharmacy
Tamil Nadu 05.2006 - 07.2009
Diploma in pharmacy - Pharmacy
Maharaja College of Pharmacy Vizianagaram
Vizianagaram 05.2004 - 06.2006
Languages
English, Hindi, Telugu and Tamil.
Certification
Project Management Professional (PMP)
Accomplishments
- Secured State 425 Rank in M. Pharm AP Entrance-2009
- Secured State 183 Rank in B.Pharm Lateral Entrance-2006
Personal Information
- Father's Name: Raghunadha Rao
- Date of Birth: 07/19/1986
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Disclaimer
I hereby declare that the above-mentioned information is correct to my knowledge, and I bear the responsibility for the correctness of the above-mentioned. Given a choice, I assure you that, I will prove to be as an asset to your organization.
Timeline
Assoc Clin Data Mgmt
IQVIA
04.2021 - 03.2022
Team Leader
Accenture
10.2018 - 04.2021
Clinical Data Coordinator
ICON clinical research
01.2017 - 10.2018
Clinical Data Analyst
PAREXEL International India Pvt Ltd.
09.2014 - 01.2017
Clinical Data Analyst
Roxaane Research
05.2013 - 09.2014
Master of Pharmacy - Pharmacology
Royal College of Pharmacy
05.2010 - 07.2012
Bachelor of Pharmacy - Pharmacy
Ultra College of Pharmacy
05.2006 - 07.2009
Diploma in pharmacy - Pharmacy
Maharaja College of Pharmacy Vizianagaram
05.2004 - 06.2006
Team Manager
Cognizant
3 2022 - Current