Experience

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  Fbae

  Jan 2000 - Feb 2015

  Treasurer

  The organization is an NGO. The focus of which is to spread awareness and educate general public about biotechnology

• 

  R v group of institutions

  Jan 2001 - Jan 2006

  Hod biotechnology
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  Nagarjuna college of engineering and technology

  Jul 2003 - Nov 2008

  Asst professor and hod
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  National law school of india university

  Jan 2008 - Jan 2009

  Mr.
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  Quintiles research (india) pvt ltd

  Nov 2008 - Oct 2011

  Assistant manager, clinical operations

  Managing team of Clinical research associates.Conduct Site selection, site initiation and site close out visits.Attending Investigator meetings.Build expertise in therapeutic areas.Coaching and mentoring team of CRAs.

• 

  Iqvia

  Oct 2011 - Jun 2016

  Clinical GDN School:• Developing curricula and training plan for different verticals under the Clinical GDN.• Liaise with QA team to design the cGDN School program to meet the requirements and standards of Q.• Discuss and get the concurrence from the Leadership team over the school format, infrastructure and financial matters.• Advise the training staff over the deliverables.• Discussion and development of soft skill training curriculum, in collaboration with Vendors.• Managing facilities and infrastructure requirements to successfully run the school program.• Generation and maintenance of reports to over school deliverables and finances. Show less • Work closely with management team to align records management to the company’s strategy, vision and objectives.• Set targets that are observable, achievable and measurable.• Achieve agreement with all the stakeholders and periodically share the reports.• Identify the resources and train them adequately, manage the transition.• Develop a design and conduct preliminary testing – assess existing systems, policies, guidelines and procedures. Develop support tools.• Implementation of the process and continue to review after implementation. Allocation of responsibilities, develop and implement conversion plan, communicate time frame, constantly assess and fine tune drawbacks in implementations involving systems, policies, procedures, guidelines and compliance. Show less Leading a team of Clinical Research Associates.Driving the business requirements of the organization and the business unit.Coordination with project management team to achieve the project deliverables.Conducting focused accompanied site visits to the investigational sites to ensure the quality and the conduct of the study as per the guidelines.Coaching and mentoring the clinical research associates.To conduct a systematic process to identify, analyze and respond to project risks, thereby removing or reducing their impact on the project.To increase the potentiality of the clinical research associates to ensure the success of the project.To improve relationships with various stake holders and there by develop confidence of customers in Quintiles.Support the clinical research associates to take intelligent and informed risk taking. Show less

  • Program Manager

    Feb 2015 - Jun 2016

  • Associate Manager, Records and Information Management

    Dec 2013 - Jan 2015

  • Associate Manager - Clinical Operations

    Oct 2011 - Nov 2013
• 

  Quintiles

  Jul 2016 - Jul 2017

  Associate manager, regulatory & start up

  • Assisting the Senior Manager in leading teams within Global Delivery Network of Regulatory & site start up activities, which could be site activation, regulatory submissions or site contracts • Line Management and Project Management Responsibilities. • Ensuring compliance with regulatory guidelines, sponsor or internal SOPs, and that all operations run smoothly and are in accordance with customer requirements. • Developing strategies to increase performance and efficiency of teams in deliverables. • Participating in business development activities, functioning as the subject matter expert in the SSU and Regulatory functions within the company.• Helping operations to run smoothly by allocating resources within the department efficiently.• Establishes, implements, and maintains standards, processes, and tools according to best practices for country and study site start up.• Act as liaison with vendors, study team members and internal/external customers related to document management deliverables during studies.• Facilitates communication within the GDN RSU team across the locations globally.• Develops and proactively manage timelines for GDN site start up and tasks quality review.• Handle escalations and develop plans / process for addressing/mitigating risks/gaps.• Ensures document standards are consistent with GCP and Regulatory requirements, and are measured through performance indicator target goals set by the study team.• Ensures the timely development of study specific procedures for study start up and document quality review utilizing approved processes and templates. Identifies best practices and participates in process improvement initiatives. Show less

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  Iqvia

  Aug 2017 - Jul 2021

  Manager, regulatory & startup

  Supporting US & Canada region for Regulatory and Startup activities.Leading a team of 50.Business unit is responsible for Essential document reviews, track and manage the documents.Filing of Essential documents in Electronic Trial Master file (eTMF).Manage, accounts and contacts in Clinical Trial Management System (CTMS).Business transition and management. Migration of process knowledge, systems and operation capabilities.Establish scope and need for business development.Participate and drive in strategic development.Recruit, train and retain resources at various grades.Driving seamless and consistenr workflow between other business units. Show less

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  Gsk

  Jul 2021 - now

  #GSKonboardinghttp://www.gskbengalurucareers.com/

  • Associate Director

    Dec 2021 - now

  • Manager - Study Delivery

    Jul 2021 - Dec 2021