Mohd Shahnavaj Siddiqui
Clinical Data Manager
Nagpur
Summary
Experienced professional seeking a challenging position with a reputable organization to expand knowledge, skills, and learnings. Committed to contributing expertise and dedication to drive success and achieve professional growth.
Overview
9
9
years of professional experience
1
1
Certification
4
4
Languages
Work History
Clinical Data Management Scientist
Accenture Operation Pvt Ltd
05.2024 - Current
- Ensure completeness and validity of the clinical trial data has gone through data entry with good quality.
- Perform Query Management, Spotfire reports, Listings Review and Dataset review and other activities as per study requirement and take action as per guidelines.
- Create, process and action data clarification forms as and when required.
- Ensure timelines set by the client in terms of discrepancies resolved and clean patient delivery are met.
- Run J review and rave reports to clean the clinical data.
- Perform SAE reconciliation review and log updates as per study requirement.
- Perform Vendor reconciliation review and log updates as per study requirement.
- Communicating with the clients and other stakeholders, monitors through emails for overview of study requirements and timelines.
- Perform site closure as when requested.
- Share study status with PDMs/DMLs as when requested.
- Attend and Participate in client indication/protocol team meetings.
- Perform Adhoc work or additional task as and when requested by Accenture PDM/Client.
- Perform QC of Accenture CDMs activities for the current protocol and for protocols that are being transitioned to accenture.
- Train and mentor Accenture CDMs newly hired in accordance with client training requirements which have been communicated to Accenture.
- Perform SAE reconciliation between SRT and STARFish tools and take action as per guidelines.
- Resolve the issue related to STARFish tool by communicating with Clinical and safety Team or by raising ticket to STARFish IT team.
Clinical Data Specialist (VRL)
IQVIA (RDS) INDIA PVT. LTD.
04.2022 - 04.2024
- Maintaining understanding of the processes study documents, including the protocol to perform proper execution on data management activities
- Performing discrepancy management and all aspects of data review in accordance with the data handling manual (DHM) and as per the agreed timelines
- Executing data listing programs and reviewing patient data consistency, quality and completeness as defined in the DHM
- Working in Conduct and close out environment in Late phase studies
- Performing freeze and lock activities by the DTL in preparation for database closure
- Perform Query Management, GPR, Listings Review and Dataset review and other activities as per study requirement
- Perform SAE reconciliation review and log updates as per study requirement
- Perform Vendor reconciliation review and log updates as per study requirement
- Develop and maintain good communications and working relationships with CDM team
- Support DOC and VRL in managing the study quality by following efficient quality review process and highlight data trends and issues to DOC as required
- Communicating with the clients and other stakeholders, monitors through emails for overview of study requirements and timelines
Senior Process Associate (CDM) (Lead DM)
TATA CONSUITANCY SERVICES
04.2019 - 04.2022
- Maintaining understanding of the processes study documents, including the protocol to perform proper execution on data management activities
- Performing discrepancy management and all aspects of data review in accordance with the data handling manual (DHM) and as per the agreed timelines
- Tracking and following up on the outstanding queries and missing eCRF data as advised by the client SDM
- Executing data listing programs and reviewing patient data consistency, quality and completeness as defined in the DHM
- Performing UAT (User acceptance Testing) of rave validation checks and communicate potential findings according to the client UAT process
- Working in Study start up, Conduct and close out environment in Late phase studies
- Working in End to End work package studies in late phase
- Uploading the study related documents on eTMF and Touchpoint as per the user manual
- Updating the study status report and making it available to the client on regular and agreed basis
- Performing freeze and lock activities by the SDM in preparation for database closure
- Retrieving PD24 form with Laboratory Reference Ranges (LRR) from eTMF system for study or site
- Clarifying any mistakes on PD24 with the monitor to avoid inconsistency on the PD24 for
- Entering Lab Reference Range into Rave using Site Admin Module
- Communicating with the clients and other stakeholders, monitors through calls for overview of study requirements and timelines
- Executing and Reviewing NON-CRF Data cleaning Spotfire reports and manual listing for the clients as well as vendors
Clinical Research Associate
ALKEM LABORATORIES LIMITED
06.2016 - 04.2019
- To serve as custodian and monitor subjects during their confinement in the clinical study
- Supervision of dosing activity and administration of investigational Product
- Execution of pilot and pivotal bioequivalence studies as per protocol, regulatory guidelines and SOPs
- Centrifugation, separation and storage of plasma samples
- Data entry into the CRF, Compilation and Review of TMF
- To serve as a co-ordinator for assigned studies and to manage the execution of those studies
- Communication to IEC, accounts, sponsor, catering, pathology laboratory, contractual staff, security, utility
- Preparation and review of Clinical study report
- Obtaining consent from volunteer for screening and study participation
- Dispensing supervision of investigational drug products
- Performing Monitoring of clinical studies activities as per Protocol and inform PI or CO-PI about any Adverse events or Serious Adverse events in the study
Education
Master of Pharmacy - Pharmacology
SMT. Kishoritai Bhoyar College Of Pharmacy
Kamptee, Nagpur, Maharashtra 04.2001 -
Bachelor of Pharmacy - Pharmacy
SMT. Kishoritai Bhoyar College of Pharmacy
Kamptee, Nagpur, Maharashtra 04.2001 -
HSSC - Science
Seth Kesarimal Porwal Junior College
Kamptee, Nagpur, Maharashtra 04.2001 -
Skills
- Discrepancy Management
- Starfish Tool handling
- Entimice tool handling
- Rave Database handling
- Vendor Reconciliation
- SAE Reconciliation
- UAT Testing
- Discrepancy Management
Certification
Pursuing Advanced Certification Course in Data Science and AI by iHUB DivyaSampark
Experimental skills
- Surgical: Intracerebroventricular and site specific cannula implantation, transcardial perfusion and brain removal.
- Instrumental: Stereotaxic Apparatus, HPLC (JASCO), Autoanalyzer, Digital Kymograph, UV.
- Blood withdrawal technique: Retro orbital, Tail Vein, Heart puncture, Tail cut, Saphenous vein.
- Route of drug administration: Oral, I.V., I.P., S.C, I.M., I.D., Retro Orbital Injection.
- Behavioral techniques: Actophotometer, Vogel Conflict Test, Rota Rod Apparatus, Light And Dark Apparatus, EPM Apparatus, T-Maze Apparatus, Forced Swim Test, Fear conditioning apparatus.
Areas Of Interest
- Clinical Data Management
- Pharmacovigilance
- Clinical Trials
- Preclinical Trials
Disclaimer
I hereby declare that the information provided by me is true to best of my knowledge.
Mohd Shahnavaj Siddiqui
Timeline
Clinical Data Management Scientist
Accenture Operation Pvt Ltd
05.2024 - Current
Clinical Data Specialist (VRL)
IQVIA (RDS) INDIA PVT. LTD.
04.2022 - 04.2024
Senior Process Associate (CDM) (Lead DM)
TATA CONSUITANCY SERVICES
04.2019 - 04.2022
Clinical Research Associate
ALKEM LABORATORIES LIMITED
06.2016 - 04.2019
Master of Pharmacy - Pharmacology
SMT. Kishoritai Bhoyar College Of Pharmacy
04.2001 -
Bachelor of Pharmacy - Pharmacy
SMT. Kishoritai Bhoyar College of Pharmacy
04.2001 -
HSSC - Science
Seth Kesarimal Porwal Junior College
04.2001 -
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