Experience

Encube Ethicals Private Limited

• India
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Senior Manager Clinical Trials

  • Dec 2017 - Sep 2021



KlinEra Corporation India

• Mumbai, Maharashtra, India

• Clinical Project Manager

  • Aug 2017 - Dec 2017

  Project Management and Line Management Project Management and Line Management



Lotus Labs Private Limited

• Mumbai Area, India

• Manager Clinical Development

  • Jan 2015 - Aug 2017

  Project Management & Line Management Project Management & Line Management



Veeda Clinical Research Private Limited

• Ahmedabad Area, India

• Project Manager

  • Nov 2011 - Jan 2015

  Plan, organize, communicate, implement and evaluate team objectives for the clinical studies; Plan and manage clinical study to achieve quality results; Develop a project management plan as appropriate for the project Manage project as per the pre defined project management plan and maintain real time project status and ensure timely deliverables. Maintain adequate documentation for project deliverables Report the project status on regular basis to various stake… Show more Plan, organize, communicate, implement and evaluate team objectives for the clinical studies; Plan and manage clinical study to achieve quality results; Develop a project management plan as appropriate for the project Manage project as per the pre defined project management plan and maintain real time project status and ensure timely deliverables. Maintain adequate documentation for project deliverables Report the project status on regular basis to various stake holders; Proactively and appropriately escalate the barriers to success of the project; Monitor the progress of each individual project deliverable against project plan and budget; Assess the overall status of the project and resources needed for next awarded project; Support the Business development team in preparation of study budget and to provide adequate response for the request for proposals Supervise activities of the CTL’s/CRA's including the scheduling of monitoring visits, other activities associated with the project (e.g., review of visit reports for completeness and accuracy, assisting monitors with problem sites, etc.), and time accountability for the project. Coordinate with vendor’s and review technical aspects of the quotation & provide inputs. Assist the regulatory team in preparing regulatory dossier. Maintain an updated working knowledge of the updates in the regulations. Organise inter departmental training and discussion for sharing knowledge & sharing. Supervise and assess the performance of the team members; Motivates trains and develops the clinical team's expertise to ensure efficient and effective day-to-day clinical operations; Mentor CRA’s and act as a line manager to achieve the departmental targets and also responsible for building a successful team. Show less Plan, organize, communicate, implement and evaluate team objectives for the clinical studies; Plan and manage clinical study to achieve quality results; Develop a project management plan as appropriate for the project Manage project as per the pre defined project management plan and maintain real time project status and ensure timely deliverables. Maintain adequate documentation for project deliverables Report the project status on regular basis to various stake… Show more Plan, organize, communicate, implement and evaluate team objectives for the clinical studies; Plan and manage clinical study to achieve quality results; Develop a project management plan as appropriate for the project Manage project as per the pre defined project management plan and maintain real time project status and ensure timely deliverables. Maintain adequate documentation for project deliverables Report the project status on regular basis to various stake holders; Proactively and appropriately escalate the barriers to success of the project; Monitor the progress of each individual project deliverable against project plan and budget; Assess the overall status of the project and resources needed for next awarded project; Support the Business development team in preparation of study budget and to provide adequate response for the request for proposals Supervise activities of the CTL’s/CRA's including the scheduling of monitoring visits, other activities associated with the project (e.g., review of visit reports for completeness and accuracy, assisting monitors with problem sites, etc.), and time accountability for the project. Coordinate with vendor’s and review technical aspects of the quotation & provide inputs. Assist the regulatory team in preparing regulatory dossier. Maintain an updated working knowledge of the updates in the regulations. Organise inter departmental training and discussion for sharing knowledge & sharing. Supervise and assess the performance of the team members; Motivates trains and develops the clinical team's expertise to ensure efficient and effective day-to-day clinical operations; Mentor CRA’s and act as a line manager to achieve the departmental targets and also responsible for building a successful team. Show less



Lambda Therapeutic Research

• India
• Research Services
• 700 & Above Employee

• Senior Clinical Team Leader

  • Apr 2009 - Nov 2011

  Planning, Initiating, Executing and Closing a clinical study as per the regulatory and project requirements.

• Senior Clinical Research Associate

  • Jan 2008 - Mar 2009

  • Identification, Selection, Initiation, Monitoring and Closure of various Studies in compliance with the ICH-GCP requirements. •  Assisting Project Managers (PMs) and Clinical Team Leaders(CTLs) in conducting feasibility studies for Clinical Trial proposals from various International Pharmaceutical Companies •  Participating in various Investigators’ Meetings and CRAs’ Meetings. •  Assisting PMs and CTLs in preparing applications for regulatory… Show more • Identification, Selection, Initiation, Monitoring and Closure of various Studies in compliance with the ICH-GCP requirements. •  Assisting Project Managers (PMs) and Clinical Team Leaders(CTLs) in conducting feasibility studies for Clinical Trial proposals from various International Pharmaceutical Companies •  Participating in various Investigators’ Meetings and CRAs’ Meetings. •  Assisting PMs and CTLs in preparing applications for regulatory approvals. •  Liaisioning with the Translating Agency. •  Communicating with the Investigators and the representatives of Sponsoring Companies. •  Assisting PMs and CTLs in liaisioning with Custom Authorities for clearance of study medication •  Facilitating recruitment of patients in different Clinical Studies. •  Coordinating EC approvals.



PPD

• United States
• Research Services
• 700 & Above Employee

• Clinical Research Associate

  • Jan 2007 - Jan 2008

   Identify potential investigators in collaboration with the sponsor  Provide trial status tracking and progress reports as required by the Project Manager or Clinical Team Manager  Conduct telephonic study feasibilities  Perform evaluation visits to assess facilities and staff so as to ensure the selection of appropriately qualified investigative sites  Follow up with regulatory executive for timely submission  Perform monitoring duties as specified in the relevant… Show more  Identify potential investigators in collaboration with the sponsor  Provide trial status tracking and progress reports as required by the Project Manager or Clinical Team Manager  Conduct telephonic study feasibilities  Perform evaluation visits to assess facilities and staff so as to ensure the selection of appropriately qualified investigative sites  Follow up with regulatory executive for timely submission  Perform monitoring duties as specified in the relevant procedures  Verify data versus source documentation and validate CRF entries  Generate and resolve queries as required  Control investigational product accountability through physical inventory and records review. Control trial supplies ordering, dispatch, return and destruction, where applicable  As necessary, prepare and submit regulatory, ethics committee and provincial applications and regulatory packages  Ensure the proper essential documents are in place prior to trial start up and on an ongoing basis throughout the study - prepare Regulatory compliance Review packages  Ensure administrative set up of sites, laboratories, storage facilities, equipment, etc  Administer investigator payments  Conduct and ensure proper trial close out and retrieval of trial materials  Archive relevant documents as per procedures  Clearly document all observations in reports and letters in a timely manner, according to accepted business writing standards. Ensure that any serious issues are immediately raised to the attention of the project management, clinical team management and clinical operations management in writing  Maintain a working knowledge of GCP, Corporate global SOPs and applicable client SOPs  Facilitate effective communication between investigational sites and the PPD project team through written, oral and electronic contacts Show less  Identify potential investigators in collaboration with the sponsor  Provide trial status tracking and progress reports as required by the Project Manager or Clinical Team Manager  Conduct telephonic study feasibilities  Perform evaluation visits to assess facilities and staff so as to ensure the selection of appropriately qualified investigative sites  Follow up with regulatory executive for timely submission  Perform monitoring duties as specified in the relevant… Show more  Identify potential investigators in collaboration with the sponsor  Provide trial status tracking and progress reports as required by the Project Manager or Clinical Team Manager  Conduct telephonic study feasibilities  Perform evaluation visits to assess facilities and staff so as to ensure the selection of appropriately qualified investigative sites  Follow up with regulatory executive for timely submission  Perform monitoring duties as specified in the relevant procedures  Verify data versus source documentation and validate CRF entries  Generate and resolve queries as required  Control investigational product accountability through physical inventory and records review. Control trial supplies ordering, dispatch, return and destruction, where applicable  As necessary, prepare and submit regulatory, ethics committee and provincial applications and regulatory packages  Ensure the proper essential documents are in place prior to trial start up and on an ongoing basis throughout the study - prepare Regulatory compliance Review packages  Ensure administrative set up of sites, laboratories, storage facilities, equipment, etc  Administer investigator payments  Conduct and ensure proper trial close out and retrieval of trial materials  Archive relevant documents as per procedures  Clearly document all observations in reports and letters in a timely manner, according to accepted business writing standards. Ensure that any serious issues are immediately raised to the attention of the project management, clinical team management and clinical operations management in writing  Maintain a working knowledge of GCP, Corporate global SOPs and applicable client SOPs  Facilitate effective communication between investigational sites and the PPD project team through written, oral and electronic contacts Show less



Reliance Life Sciences Pvt. Ltd.

• India
• Biotechnology Research
• 700 & Above Employee

• Clinical Trial Supply Management

  • Sep 2005 - Dec 2006

   Handled clinical laboratory supplies for clinical trials.  Handled clinical laboratory supplies for clinical trials.



SRL Ranbaxy Ltd.

• Scientific Officer

  • Dec 2002 - Sep 2005

   Processing human tissue samples.  Performing Immunohisto chemistry  Processing human tissue samples.  Performing Immunohisto chemistry