Experience

COD Research Pvt Ltd
• Founder

  • Jan 2017 - Jan 2021

COD Research CSM
• Founder and Managing Director

  • Jan 2017 - Jan 2019

IICRM (International Institute of Clinical Research and risk Management)
• Director

  • Dec 2015 - Nov 2016


IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Sr.Clinical Process Associate

  • Nov 2014 - Dec 2015

  Perform complex processes and tasks that eventually result in high quality deliverable that are completed according to service level agreements (SLAs) and within project timelines. Establish and maintain effective project/ site communications. Create and maintain relevant project documents. Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information. Participate in document management… Show more Perform complex processes and tasks that eventually result in high quality deliverable that are completed according to service level agreements (SLAs) and within project timelines. Establish and maintain effective project/ site communications. Create and maintain relevant project documents. Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information. Participate in document management (creation, review, maintenance, storage, as applicable). Provide support & mentor/training to coworkers within RIM. Serve as TMF contact for documentation to Project team, cross functional departments to ensure high quality TMF deliverables are met on time. Follow processes for set up, maintenance, and support for assigned TMF projects. Facilitate collecting, processing and disposition of various project-related records for paper & electronic documents to sponsor. Follow applicable SOP’s to ensure completeness & accuracy of eTMF. Prepare/present TMF related information at internal meetings in a globally consistent format. Provide support & involvement with internal quality or audit processes as relevant Accountable for delivery of assigned TMF activities in accordance with project requirements & SLA’s. Manage documentation associated with assigned clinical trials. Follow records management tasks, policies, and procedures. Conduct review documents with compliance to IQVIA or customer file plans and SOPs SME on all designated Sponsor-specific TMF requirements (e.g. file format, process, and export/shipping requirements). Provide regular updates on performance to SLAs. Running system reports-CTMS, IXRS, EDC(Inform and Rave) Performing QC in CTMS against IXRS/EDC for the payment batch approval. Checking incomplete/ missing page, query aging and follow-up with CRAs, LCA and CL for resolution. Review of PD against protocol guidance document. Show less Perform complex processes and tasks that eventually result in high quality deliverable that are completed according to service level agreements (SLAs) and within project timelines. Establish and maintain effective project/ site communications. Create and maintain relevant project documents. Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information. Participate in document management… Show more Perform complex processes and tasks that eventually result in high quality deliverable that are completed according to service level agreements (SLAs) and within project timelines. Establish and maintain effective project/ site communications. Create and maintain relevant project documents. Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information. Participate in document management (creation, review, maintenance, storage, as applicable). Provide support & mentor/training to coworkers within RIM. Serve as TMF contact for documentation to Project team, cross functional departments to ensure high quality TMF deliverables are met on time. Follow processes for set up, maintenance, and support for assigned TMF projects. Facilitate collecting, processing and disposition of various project-related records for paper & electronic documents to sponsor. Follow applicable SOP’s to ensure completeness & accuracy of eTMF. Prepare/present TMF related information at internal meetings in a globally consistent format. Provide support & involvement with internal quality or audit processes as relevant Accountable for delivery of assigned TMF activities in accordance with project requirements & SLA’s. Manage documentation associated with assigned clinical trials. Follow records management tasks, policies, and procedures. Conduct review documents with compliance to IQVIA or customer file plans and SOPs SME on all designated Sponsor-specific TMF requirements (e.g. file format, process, and export/shipping requirements). Provide regular updates on performance to SLAs. Running system reports-CTMS, IXRS, EDC(Inform and Rave) Performing QC in CTMS against IXRS/EDC for the payment batch approval. Checking incomplete/ missing page, query aging and follow-up with CRAs, LCA and CL for resolution. Review of PD against protocol guidance document. Show less



Tech Observer

• United Arab Emirates
• Technology, Information and Internet
• 1 - 100 Employee

• Clinical Research Associate

  • May 2012 - Jun 2013

  Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site. Liaising with doctors/consultants or investigators on conducting the trial. 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… Show more Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site. Liaising with doctors/consultants or investigators on conducting the trial. 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. Ensuring all unused trial supplies are accounted for. Writing visit reports, filing and collecting trial documentation and reports. Show less Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site. Liaising with doctors/consultants or investigators on conducting the trial. 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… Show more Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site. Liaising with doctors/consultants or investigators on conducting the trial. 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. Ensuring all unused trial supplies are accounted for. Writing visit reports, filing and collecting trial documentation and reports. Show less



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Research Associate

  • Jun 2010 - May 2012

  Identifying and briefing appropriate trial investigators (clinicians). setting up and disbanding trial study centers. designing trial materials and supplying study centers with sufficient quantities. providing clinicians with instructions on how to conduct the trials collecting and authenticating data collection forms (commonly known as case report forms) monitoring progress throughout the duration of the trial Identifying/selecting an investigator who will be responsible for… Show more Identifying and briefing appropriate trial investigators (clinicians). setting up and disbanding trial study centers. designing trial materials and supplying study centers with sufficient quantities. providing clinicians with instructions on how to conduct the trials collecting and authenticating data collection forms (commonly known as case report forms) monitoring progress throughout the duration of the trial Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site. Liaising with doctors/consultants or investigators on conducting the trial. 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, investigation drug accountability, and adverse event review. Ensuring all unused trial supplies are accounted for. Writing visit reports, filing and collecting trial documentation and reports. Show less Identifying and briefing appropriate trial investigators (clinicians). setting up and disbanding trial study centers. designing trial materials and supplying study centers with sufficient quantities. providing clinicians with instructions on how to conduct the trials collecting and authenticating data collection forms (commonly known as case report forms) monitoring progress throughout the duration of the trial Identifying/selecting an investigator who will be responsible for… Show more Identifying and briefing appropriate trial investigators (clinicians). setting up and disbanding trial study centers. designing trial materials and supplying study centers with sufficient quantities. providing clinicians with instructions on how to conduct the trials collecting and authenticating data collection forms (commonly known as case report forms) monitoring progress throughout the duration of the trial Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site. Liaising with doctors/consultants or investigators on conducting the trial. 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, investigation drug accountability, and adverse event review. Ensuring all unused trial supplies are accounted for. Writing visit reports, filing and collecting trial documentation and reports. Show less



Intas Pharmaceuticals Ltd. (Biopharma Division)

• Clinical Trial Assistant

  • Apr 2009 - Jun 2010

  • Site Feasibilities. • Management of Ethics Committee submission on clinical study. • Scheduling patient visits as per protocol schedule of events. • To maintain the essential documents at the site. • To maintain and submit the progress status of the trials to the Ethics Committee. • Assisting for Regulatory Affairs department. • To maintain and submit revisions & amendments of trials related documents to Ethics Committee. • To maintain & document relevant communications… Show more • Site Feasibilities. • Management of Ethics Committee submission on clinical study. • Scheduling patient visits as per protocol schedule of events. • To maintain the essential documents at the site. • To maintain and submit the progress status of the trials to the Ethics Committee. • Assisting for Regulatory Affairs department. • To maintain and submit revisions & amendments of trials related documents to Ethics Committee. • To maintain & document relevant communications with Sponsors/CRO i.e. meeting notes, letters and telephone calls. Show less • Site Feasibilities. • Management of Ethics Committee submission on clinical study. • Scheduling patient visits as per protocol schedule of events. • To maintain the essential documents at the site. • To maintain and submit the progress status of the trials to the Ethics Committee. • Assisting for Regulatory Affairs department. • To maintain and submit revisions & amendments of trials related documents to Ethics Committee. • To maintain & document relevant communications… Show more • Site Feasibilities. • Management of Ethics Committee submission on clinical study. • Scheduling patient visits as per protocol schedule of events. • To maintain the essential documents at the site. • To maintain and submit the progress status of the trials to the Ethics Committee. • Assisting for Regulatory Affairs department. • To maintain and submit revisions & amendments of trials related documents to Ethics Committee. • To maintain & document relevant communications with Sponsors/CRO i.e. meeting notes, letters and telephone calls. Show less