Pushkar Narayan Toke
Flat No 4, Janakiram CHS, Hanuman Chowk, Mulund (E), Mumbai
Summary
Clinical Project Manager with more than 10.5 years of overall experience from being Clinical Research Coordinator, Clinical Trial Assistant, Clinical Research Associate to Project Manager in managing clinical research projects and ensuring successful project delivery. Skilled in cross-functional team management, client relationship management, clinical research methodologies, ensuring regulatory compliance and effective communication. Able to work independently in a virtual setting and possess a proactive and innovative problem-solving mindset while maintaining a keen focus on quality and patient safety.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Clinical Team Manager
(Working for Johnson & Johnson Pvt Ltd as Project Manager through ICON)
Mumbai
2021.12 - Current
- Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA, CRA and CTM/GTL
- Electronic submission to HA for new studies and amendments.
- Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents and applicable regulations
- Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting
- Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate
- Maintains and updates trial management systems
- Uses study tools and management reports available to analyse trial progress
- Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams
- May submit requests for vendor services and may support vendor selection
- In certain situations, may assist in negotiation of trial site contracts and budgets
- Forecasts and manage country/local trial budget to ensure accurate finance reporting and trial delivered –within budget
- Schedule and conduct a local/country investigator meeting
- Conducts local trial team meetings and provides or facilitates CRA training when needed (i.e Implementation of study amendment-and changes in study related processes)
- Reviews and approves Monitoring Visit Reports submitted by CRA; identifies issues and/or trends across a trial project and escalates deviation issues to the global team and Functional Manager.
- Prepares country specific informed consent in accordance with procedural document/templates & Reviews and manages site specific informed consent forms
- Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements
- Works with team to ensure CAPA is implemented for audits and inspection or any quality related visits
- Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials
- Actively contributes to process improvement, training and mentoring of CTAs, CRA and other PMs
- Conducts accompanied site visits with CRA
- May assumes additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”
- Serves as primary liaison for clinical monitoring issues, interacting with clients, vendors and other functional areas, escalating as required
- Forecasts units and hours and generic resources for the start-up and monitoring activities, determines worked units and hours, analyzing forecasted and worked activities to ensure adherence to contract and budget Provides Time Entry Guidelines to the relevant study team members in adherence with project scope and budget; monitor burn rates, escalating issues with potential solutions to the Project Manager (PM)
- Reviews filing of Essential Documents in the electronic Trial Master File to ensure sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines
- Collaborates with Quality Assurance (QA) to identify sites needing corrective and preventative action plans, responds completely and accurately to audit reports, provides team with project-specific audit process to ensure adequate preparations/reviews of all audit responses prior to submission to internal clinical review team/QA and then Sponsor Organizes project specific compliance plans for key processes, tools and systems
- Identifies metrics and trends across team members, countries, regions and uses the information to promote improvement in quality and consistency of execution.
Clinical Research Associate 3
(Working for Johnson & Johnson Pvt Ltd through ICON)
Mumbai
2020.07 - 2021.11
Clinical Research Associate-2
IQVIA
Mumbai
2019.03 - 2020.07
Clinical Research Associate
Novartis Healthcare Private Limited
Mumbai
2016.08 - 2019.03
Clinical Research Associate
Biosphere Clinical Research Pvt. Ltd
2015.12 - 2016.07
Clinical Trial Assistant
KlinEra Corporation
Mumbai
2015.03 - 2015.12
Clinical Research Coordinator
KEM Hospital
Mumbai
2014.06 - 2015.03
Clinical Research Coordinator
Fortis Hospital
Mumbai
2013.11 - 2014.06
Education
MBA - Healthcare And Pharmaceutical Management
IES Management College And Research Centre
Mumbai04.2012
Post Graduate Diploma - Clinical Research Management and Regulatory Affairs
Haffkine Institute
Parel, Mumbai01.2010
Advanced Diploma - Food Science and Quality Control
Ruia College
Mumbai04.2009
Bachelor of Science - Biochemistry
Ruia College
Mumbai04.2009
Skills
- Clinical Project Management.
- Communication and interpersonal skills.
- Cross-Functional Team Leadership.
- Client Relationship Management.
- Risk Management.
- Project Planning and Execution.
- Regulatory Compliance.
Accomplishments
- Achieved work of wonder certificate of appreciation for “Exemplary contribution & readiness during CDA & IM audits”, 2017
- Received Hats off award for “demonstrating Novartis values of Performance & Collaboration in relentless efforts for early termination of the EXJ821 Study in challenging situation through effective coordination across functional teams”, 2018
- Led team to achieve enrollment and DBL activities and , earning recognition from upper management and reward, 2021 and 2022.
- Successful conduct of International Clinical Trials Day in year 2019, 2021, 2022.
- Relevant Non-Clinical Training/Meetings
- Attended 1 day workshop on “e-MONITOR : Evolving Role of a Clinical Research Associate” conducted by ISCR
- Attended Investigator meetings
- 2 months internship in Glenmark Pharmaceuticals on project entitled “Acceptance of new antibiotic drug combination (Levofloxacin+ Cefixime) –an empirical research.” As a summer intern in 2011
- CSR Project on Waste management and recycling (Inseed)
Certification
- Vaccines : Covid-19 : Phase III
- Oncology : Non Small Cell Lung Cancer : Phase III
- Oncology : Multiple Myeloma: Phase III and IV
- Oncology : Mantle Cell Lymphoma : Phase III and IV
- Oncology : Breast Cancer : Phase III
- Urology : Bladder Cancer : Phase II
- Urology : Advanced Urothelial cancer : Phase III
- Metabolic Diseases : Diabetes : Phase III & IV
- Rheumatology : Rheumatoid Arthritis : Phase III
- Immunology : Juvenile Idiopathic Arthritis : Phase III
- Gastroenterology : Ulcerative colitis : Phase III
- Respiratory : COPD : Phase III
- Respiratory : Asthma : Phase III
- Ophthalmology : Dry eyes : Phase III
- Ophthalmology : Diabetic Retinopathy : Phase IV
- Dermatology : Urticaria : Phase III
- Transplant : Liver Transplant : Phase IV
- Anti-Fungal : Oral Candidiasis : Phase III
- Orthopedics : Osteoarthritis : Phase III
- Gastroenterology : Hepatitis : Phase II, III, IV
- Ophthalmology : Uveitis : Phase III
- Psychiatry : Schizophrenia : Phase III
- Cardiology : Percutaneous Coronary Intervention : Phase IV
- Cardiology : Biomarker in Heart Failure : Phase IV
Languages
- English
- Marathi
- Hindi
Timeline
Clinical Team Manager
(Working for Johnson & Johnson Pvt Ltd as Project Manager through ICON)
2021.12 - Current
Clinical Research Associate 3
(Working for Johnson & Johnson Pvt Ltd through ICON)
2020.07 - 2021.11
Clinical Research Associate-2
IQVIA
2019.03 - 2020.07
Clinical Research Associate
Novartis Healthcare Private Limited
2016.08 - 2019.03
Clinical Research Associate
Biosphere Clinical Research Pvt. Ltd
2015.12 - 2016.07
Clinical Trial Assistant
KlinEra Corporation
2015.03 - 2015.12
Clinical Research Coordinator
KEM Hospital
2014.06 - 2015.03
Clinical Research Coordinator
Fortis Hospital
2013.11 - 2014.06
MBA - Healthcare And Pharmaceutical Management
IES Management College And Research Centre
Post Graduate Diploma - Clinical Research Management and Regulatory Affairs
Haffkine Institute
Advanced Diploma - Food Science and Quality Control
Ruia College
Bachelor of Science - Biochemistry
Ruia College
- Vaccines : Covid-19 : Phase III
- Oncology : Non Small Cell Lung Cancer : Phase III
- Oncology : Multiple Myeloma: Phase III and IV
- Oncology : Mantle Cell Lymphoma : Phase III and IV
- Oncology : Breast Cancer : Phase III
- Urology : Bladder Cancer : Phase II
- Urology : Advanced Urothelial cancer : Phase III
- Metabolic Diseases : Diabetes : Phase III & IV
- Rheumatology : Rheumatoid Arthritis : Phase III
- Immunology : Juvenile Idiopathic Arthritis : Phase III
- Gastroenterology : Ulcerative colitis : Phase III
- Respiratory : COPD : Phase III
- Respiratory : Asthma : Phase III
- Ophthalmology : Dry eyes : Phase III
- Ophthalmology : Diabetic Retinopathy : Phase IV
- Dermatology : Urticaria : Phase III
- Transplant : Liver Transplant : Phase IV
- Anti-Fungal : Oral Candidiasis : Phase III
- Orthopedics : Osteoarthritis : Phase III
- Gastroenterology : Hepatitis : Phase II, III, IV
- Ophthalmology : Uveitis : Phase III
- Psychiatry : Schizophrenia : Phase III
- Cardiology : Percutaneous Coronary Intervention : Phase IV
- Cardiology : Biomarker in Heart Failure : Phase IV
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