Taj Uddin Email & Phone Number

Lucknow, Up, In

New Delhi, Delhi, India

New Delhi Area, India

New Delhi Area, India

•Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site. •Setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product. •Training the study staff in standard operating procedure for the clinical trials as per applicable regulatory requirements.•Verify that investigator and investigator’s team are adequately trained and comply with the protocol. •Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements. •Monitoring the trial throughout specified duration involving monitoring visit to the trial sites. •Source data verification •Informed consent form review, case report form review, investigational drug accountability, and adverse event review. •Ensure the timely reporting of AE and SAE to the sponsor and regulatory agencies in accordnace with the applicable regulatory guideline•Ensure the reporting of any protocol deviation/protocol violation observed during the monitoring visit in accordance with the applicable regulatory guidelines. •Ensuring all used and unused trial supplies accountability.•Writing visit reports, filing and collecting trial documentation and reports.

Noida Area, India

1. Performing pre-initiation activity which includes site feasibility,investigator selection,analysis of potential patient recruitment,selection of vendor,etc.2. Assist in the preparation of trial related documentation (protocols, Case report forms, investigators brochures,consent documents, letters of agreement, confidentiality agreements and CSR).3. Ensure the preparation and completeness of various trial files(eg:TMF,SSF and ISF) as per applicableCRO/Sponsor SOP and in accordance with GCP and other regulatory guidelines.4.Monitoring the assigned clinical trial as per CRO/Sponsor SOPs ,study protocol and in accordance with GCP and other regulatory guidelines.5. Ensure the timely reporting of AE and SAE to the sponsor and regulatory agencies in accordnace with the applicable regulatory guideline.6.Ensure timely completion and submission of Case Report Forms/eCRF according to CRF/eCRF guidelines,Clinical Monitoring Plan or Data Management Plan.7.Ensure timely resolution of eCRF queries or DCF in paper CRF studies.

Noida Area, India

1.Assisting in the management of the designated clinical trials which includes site feasibility,investigator selection and analysis of potential patient recruitment sites,vendor selection,etc.2.Update the progress of assigned studies by tracking regulatory submissions and approvals,recruitment and enrolment, CRF completion and submission, and data query generation and resolution to the sponsor and study manager.3.Preparation and completeness of various trial files(eg:TMF,SSF and ISF) as per applicableCRO/Sponsor SOP and in accordance with GCP and other regulatory guidelines.4.Monitoring the assigned clinical trial study data as per CRO/Sponsor SOPs ,study protocol and in accordance with GCP and other regulatory guidelines.5.Ensure the timely reporting of AE and SAE to the sponsor and regulatory agencies in accordnace with the applicable regulatory guideline.6. Ensure the reporting of any protocol deviation/protocol violation observed during the monitoring visit in accordance with the applicable regulatory guidelines.7.Ensure timely completion and submission of Case Report Forms/eCRF according to CRF/eCRF guidelines,Clinical Monitoring Plan or Data Management Plan.8. Ensure timely resolution of eCRF queries or DCF in paper CRF studies.

Noida Area, India

1. Assist in drafting quality assurance policies and standard work procedures(SOP's)and its implentation2. Conduct internal monitoring and inspection of procedure to ensure quality standard of procedure and activity3. Analyze the procedures and activity to identify areas for improvement in the quality system4. Assist in developing corrective and preventive actions. 5. Identify training needs and organize traininginterventions to meet quality standards

Faridabad

Quality control officer in bioanalytical and clinic deptt.

Gurgaon, India

Worked on various generic molecule method development and validation in Bioanalytical Lab.

Master Of Pharmacy, Pharmaceutics And Drug Design, A

Activities and Societies: 1. worked on formulation and evaluation of clotrimazole soap bar. 2. Method develoment and validation.

Bachelor'S Degree, Pharmacy, A

Activities and Societies: Done internship in vibgyor on topic "validation and quality control in manufacturing unit"