Ajay Singh Solanki work email
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Around 24 years of experience working in Clinical Research industry. Currently providing Clinical Research Consultancy services to Pharma and CRO in Clinical Project Management and Clinical Operations. In past, had lead Global Clinical Project Management & Clinical Operations at SPARC. Was Responsible for the PM team managing Direct and Outsourced, local and global clinical trials while working in close coordination with various teams including formulation development, medical sciences, regulatory, analytical, manufacturing and others. Earlier, at IQVIA (Quintiles), Developed and Lead Site Visit Report Reviewers' and Risk Based Monitoring (RBM) teams in Global Delivery Network (GDN - Centralized Clinical Operations) with upto 200 team members. Developed an India based team of dedicated Site Visit Report Reviewers/Site Report Specialists (SRSs) and lead and managed India and APAC SRS teams. Also created various other India based service delivery teams to cater to different departments across the globe including - QA admin team, QA SOP team, Late phase studies' CTMS legacy data entry teams. Also developed and lead the Data driven Trial Excellence (DTE) teams including - 1. DTE - Centralized Clinical Operation and 2. DTE - Service Delivery Team. Worked in close coordination with global counterparts and managed end to end right from planning and inception of the functional teams through training, establishing processes and metrics till the teams became operational.Earlier at IQVIA, managed clinical operations team of 3 office locations with a team of 90. Was responsible for Operations and Deliverables, Resourcing, Performance management and Development along with General Management and Budgeting for clinical operations teams at three office locations.
Freelance
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Clinical Research Consultant - Pharma And CroFreelance Aug 2021 - PresentIndiaProviding support to Pharma Companies and Contract Research Organizations (CROs) involved in Clinical Trials. This includes providing Oversight support and Guidance to Project Teams regarding:Global Clinical TrialsClinical Operations related tasks, activities.Clinical Project Management related tasks, activities.Good Clinical Practice (GCP) related issues, discussion points.New Drugs and Clinical Trial Rules, 2019 related aspects.Clinical Trial Document review.On boarding of Clinical Operations, Clinical Project Management personnel.Hiring and retention of Project Management and clinical operations personnel.Mentoring and Coaching of Project Management and Clinical Operations personnel.Acting as a sounding board for Clinical Research Professionals on Clinical Trial Related discussions.
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Associate Vice President, Global Head - Clinical Project Management And Clinical OperationsSun Pharma Advanced Research Company Ltd. Apr 2019 - Jul 2021Mumbai Area, IndiaLead Project Management and Clinical Operations at SPARC comprising of Project Managers, Clinical Research Associates and Clinical Trial Associates. Responsible for the Clinops teams managing local and global clinical trials while working in close coordination with various internal teams including formulation development, medical sciences, regulatory, analytical, manufacturing, program management and other teams across Sun Pharma Industries Ltd. and SPARC and also external ones including CROs, Labs and various other service providers. Drove project planning, project implementation and project management, from inception till close out for studies across phases including Pilot and Pivotal BE studies in patients, Phase I, II and III studies across various therapy areas including CNS, Oncology, Endocrinology, RA, Respiratory, Ophthalmology etc. Was responsible for resource planning, resource allocation and resource management, performance management, training and budgeting for clinical operations. Also involved with vendor selection and vendor management for clinical studies including CROs, Labs, DM, EDC, IWRS and other vendors. -
Sr. Gm, Head - Clinical Project Management And Clinical OperationsSun Pharma Advanced Research Company (Sparc) Ltd. Apr 2016 - Mar 2019Mumbai Area, India -
General Manager, Head - Clinical Operations And Project ManagementSun Pharma Advanced Research Company (Sparc) Ltd. Feb 2015 - Mar 2016Mumbai -
Director And Associate Dir., Clinical Process Delivery, Global Delivery NetworkIqvia India Jun 2013 - Feb 2015AhmedabadDeveloped and Lead Site Visit Report Reviewers' and Risk Based Monitoring (RBM) teams in Global Delivery Network (GDN, earlier called Global Process Delivery Center - GPDC) with upto 200 team members. Developed an India based team of dedicated Site Visit Report Reviewers or Site Report Specialists (SRSs) who were responsible for reviewing site visit reports in regional or global studies for monitors based in countries across the globe. Had also created various other India based service delivery teams to cater to different departments across the globe. Managed 4 different service delivery teams who were catering to global departments (Site Report Specialists team in India and APAC, QA admin team, QA SOP team, Late phase studies' CTMS legacy data entry teams). Also developed and lead the Clinical GDN teams including - 1. Data driven Trial Excellence - Centralized Clinical Operation (DTE-CCO) team of Lead Clinical Analysts (LCAs), Clinical Analysts (CAs or Remote Monitors), Clinical Analyst Support (CASs) working across multiple streams including - Remote monitoring, Investigator Payments, File Reviews and Safety Letter Tracking. 2. DTE - Service Delivery Team (DTE - SDT) working across multiple streams including - Contact Center Support for sites and Vendor System Access Support. Worked in close coordination with global counterparts and managed end to end right from planning and inception of the teams through training, establishing processes and metrics till the teams becoming fully functional. -
Associate Director, Clinical OperationsIqvia India Aug 2008 - May 2013Ahmedabad Area, IndiaManaged clinical operations team of Clinical Research Associates, Clinical Trial Assistants and Clinical Line Managers for more than 4 years. Had managed clinical operations team at 3 office locations (Ahmedabd, Mumbai and Delhi) with a team of upto 90. Was responsible for clinical operations team's Functions and Deliverables, Resourcing, Performance management and Development. Also responsible for General Management, Budget and study feasibility review in Psychiatry and Coordination and Collaboration with other departments. -
Clinical Study Manager And Sr. Clinical Study ManagerIqvia India Apr 2006 - Jul 2008Ahmedabad -
Clinical Team Leader And Sr. Clinical Team LeaderIqvia India Jan 2004 - Mar 2006Ahmedabad -
Cta, Cra And Sr. Clinical Research AssociateIqvia India Apr 2001 - Dec 2003Ahmedabad Area, India -
Marketing OfficerCadila Pharma, Micro Nova Pharmaceuticals Dec 1999 - Mar 2001Udaipur, Jaipur
Ajay Singh Solanki Skills
Ajay Singh Solanki Education Details
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Indian Institute Of Management, AhmedabadTier-1 Of 3-Tier Middle Managment Program (Management Development Program) -
Marketing/Marketing Management, General -
B. N. College Of Pharmaceutical SciencesBachelor Of Pharmacy (B.Pharm.)
Frequently Asked Questions about Ajay Singh Solanki
What company does Ajay Singh Solanki work for?
Ajay Singh Solanki works for Freelance
What is Ajay Singh Solanki's role at the current company?
Ajay Singh Solanki's current role is Clinical Research Consultant - Pharma and CRO.
What is Ajay Singh Solanki's email address?
Ajay Singh Solanki's email address is aj****@****les.com
What schools did Ajay Singh Solanki attend?
Ajay Singh Solanki attended Indian Institute Of Management, Ahmedabad, Mohanlal Sukhadia University, B. N. College Of Pharmaceutical Sciences.
What skills is Ajay Singh Solanki known for?
Ajay Singh Solanki has skills like Clinical Trials, Clinical Research, Cro, Ich Gcp, Pharmaceutical Industry, Cro Management, Electronic Data Capture, Gcp, Clinical Operations, Edc, Clinical Monitoring, Clinical Development.
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Ajay Singh Solanki
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