Taj Uddin
Senior Clinical Research Associate
Unnao
Summary
Dynamic Clinical Operations professional with extensive experience in the pharmaceuticals industry with proven ability of leading role in the clinical research field. Skilled in Clinical Project Management, Study Start Up Activities, Budget/Agreement Execution & Finalization, Study Execution, Vendor Management, Risk based Monitoring (RBQM) and Collaboration with different stakeholder along with excellent communication and problem-solving skills. Talents include in-depth knowledge of ICH guidelines & Other regulatory guidelines.
Overview
12
12
years of professional experience
Work History
Senior Clinical Research Associate - Clinical Operations
CLINNEX RESEARCH PVT.LTD.
04.2024 - Current
- Manage the study start-up activity which includes Feasibility activity, Site assessment, Regulatory Submission, Study Timelines Projection based on the feasibility and SQV evaluation, Budget Negotiation along with Contract execution and timely site activation.
- Assist project management team and other cross functional team for study plans preparation and review during the study set-up phase and ongoing phase.
- Act as key member in assisting the project management team and other cross functional team for tracking the project status update in align with different project matrix (eg: Recruitment milestone, regulatory updates, safety updates, system compliance & finance tracking)
- Assist the project management team in identifying any unforeseen risk and develop & implement mitigation plan to overcome.
- Act as a single point of contact for clients, vendors and project management team.
- Ensure team compliance with project-specific training matrix and study plans.
- Review site visit reports and ensure monitoring and reporting standards are met.
- Assist project management team in the audit/ inspection preparation and resolution of audit/ inspection findings.
- Conduct on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites.
- Act as mentors for the new joinee CRA and assist in their development and training.
Lead Monitor-CRA- Clinical Operations
AstraZeneca Pharma India Ltd
10.2020 - 08.2021
- Lead the study start up activity (eg: Identification of potential site; budget finalization, Study Document drafting and finalization at country level, CSA finalization, Regulatory Submission, EC Submission etc.)
- Assist Local study team in preparation of study plan and strategy for patient recruitment.
- Assist the Study team in planning of study milestone Starting from Study Start-up to Close out phase.
- Play an active role in the project team in ensuring compliance with study plans (eg: Monitoring Plan, eTMF Plans etc.)
- Perform Site Selection Visit, Site Initiation Visit, Site Monitoring Visit and Site Close-out Visit in accordance with the protocol, other applicable regulatory guidelines including local regulatory guidelines and applicable organizational SOP.
- Keep a close association with site(s) for: Patient Recruitment, Patient follow-up and Patient Follow-Up and Protocol related activities.
- Audit Respond In accordance to CAPA.
- Act as a communication link between Local Study Team, and the site.
- Attend and facilitate Investigator Meeting.
- Training of Investigator on Protocol and other applicable regulatory guidelines including local regulatory guideline.
- Act as coach and mentor to oversee the issue and challenges faced by other junior team member and actively respond and guide them.
Clinical Research Associate II- FSP (ROCHE)
IQVIA RDS (INDIA) PVT LTD.
12.2018 - 10.2020
- To perform site feasibilities, site initiation visit, site monitoring and close out activities and to prepare the reports for same in accordance with SOPs
- Monitoring the clinical sites as per monitoring plan to ensure that Principal Investigator(s) are conducting the study as per Protocol, ICH-GCP & SOPs
- Training of Investigator and site team personnel on Protocol and other applicable regulatory guidelines including local regulatory guideline
- EC Submission
- Ensure the timely reporting of SAE to the sponsor and regulatory agencies in accordance with the applicable regulatory guideline
- Ensure timely completion and submission of Case Report Forms/eCRF according to CRF/eCRF guidelines, Clinical Monitoring Plan and Data Management Plan
- To review the site payment and releasing them as per signed clinical trial agreement
- Attend applicable LST meetings and GST meeting
- To ensure that various study trackers (payment, PD, AE/SAE, CIOMS, ICF tracking, MV plan, DM queries) are updated at regular intervals
- Monitor and update the study system and tools (CTMS, eTMF & SIP) as per study plan.
Clinical Research Associate - Clinical Operations
Lambda Therapeutic Research LTD.
01.2018 - 12.2018
- Conducting independent clinical site feasibility studies as well as clinical site identification starting from Phase-III to Phase-IV studies, doing pre-site initiation visit (PSIV), performing initiation of study
- To perform site initiation and Site Close Out visit as per monitoring plan and to prepare various site visit reports.
- To train site team on GCP, protocol and regulatory requirements, etc.
- Monitoring the clinical sites as per monitoring plan to ensure that Principal Investigator(s) are conducting the study as per Protocol, ICH-GCP & SOPs
- Assisting the site for submission of all essential documents to the Institutional review board (IRB) for their review process.
- Validate the consistency between the source and data captured on the eCRFs to ensure credible and quality data is generated from the site.
- Manage safety reporting - review SAEs, ensure all stakeholders are notified and that all safety related company procedures and regulatory requirements are complied.
- Maintenance of all ISF (Investigator Site File) & TMF (Trial Master File) throughout the duration of the clinical trial.
- Manage the shipment of all clinical trial supplies in co-ordination with the CTL.
- Maintenance of all essential documents throughout the duration of clinical trial including investigational product (IP) accountability at various sites.
CRA-II
IR Innovate Research Pvt Ltd.
06.2016 - 01.2018
- Assist in the preparation of Investigators Brochure (IB), Protocol, Informed consent documents and all documents for submission to the Institutional Ethics Committee (IEC)
- To prepare and/or upgrade the SOP for operations team and to implement the same with version & supersede number.
- To prepare CDA and Clinical Trial Agreement with vendors and Investigators.
- To finalize the study budgets with vendors & investigators in coordination with Sr Management
- To perform independent Site Evaluation, Initiation, Monitoring and Close-out activities
- To train internal as well as external team for protocol, CRF filing guidelines, SIV, SMV, SCV, Informed Consent Process.
- To review dossiers prepared by site CRA meant for Ethics Committee submission
- Doing site monitoring of all the other clinical sites which are managed by other associated partner CRO across the different regions to make sure that principal investigators are conducting the study as per the protocol, ICH-GCP and SOPs.
- To ensure 100% source data verification so-that credible & quality data is being generated from the site.
- To report the enrollment status from sites to the Sr. Management.
- Track protocol deviation, adverse events and study material at sites & to assist site in recruitment strategies.
Quality Control Officer-I
FORTIS CLINICAL RESEARCH LIMITED.
09.2013 - 05.2014
- Review of Protocol, Informed consent documents and all study documents
- Review of CRF data in compliance to protocol
- Review of analytical data as per established method development and method validation.
- Review of TMF files and Analytical report for completeness.
- Assist QA team in audit and inspection.
Education
Master Of Pharmacy - Pharmaceutics
Amity University
Lucknow01.2013
Bachelor of Pharmacy - undefined
Integral University
Lucknow01.2010
Skills
Clinical trial management
Accomplishments
- Experienced Clinical Trial Professional with a demonstrated history of working experience in various position such as CTL, Lead Monitor and Clinical Research Associate in more than 10+ different therapeutics area.
- Successfully clear more than 20+ Regulatory (DCGI, FDA, etc.) and Sponsor audit.
- Recognized for good management skill in the study completion by the sponsor in one of the International Journal.
Additional Information
Computer Skills – MS Office, Windows 2010/XP, Linux, ChatGPT and Power BI
Timeline
Senior Clinical Research Associate - Clinical Operations
CLINNEX RESEARCH PVT.LTD.
04.2024 - Current
Lead Monitor-CRA- Clinical Operations
AstraZeneca Pharma India Ltd
10.2020 - 08.2021
Clinical Research Associate II- FSP (ROCHE)
IQVIA RDS (INDIA) PVT LTD.
12.2018 - 10.2020
Clinical Research Associate - Clinical Operations
Lambda Therapeutic Research LTD.
01.2018 - 12.2018
CRA-II
IR Innovate Research Pvt Ltd.
06.2016 - 01.2018
Quality Control Officer-I
FORTIS CLINICAL RESEARCH LIMITED.
09.2013 - 05.2014
Bachelor of Pharmacy - undefined
Integral University
Master Of Pharmacy - Pharmaceutics
Amity University
Other Details
Language Known: English, Hindi,
Marital Status: Married
Reference: Upon request.
Hobbies
Playing Play Station and Travelling with Family
Declaration
I, Tajuddin hereby declare that all the information furnished here is true to the best of my knowledge