Dr.Sridevi Muthusivam
Clinical Research Professional
Chennai
Summary
An accomplished Passionate visionary Medical professional with clinical research expertise over 19 years of work experience. A proven track record of leading and managing clinical operations team related activities for Bioavailability/Bioequivalence for generics and PK /PD studies on patients and clinical trial.
Over two decade experience of handling different internal stakeholders and external service providers in different geographies for the effective collaboration and execution of the studies. . Lead and manage team of scientists across three geographic location of India, US and Canada. Part of senior management leadership team and Instrumental in implementation of strategic goals. Implemented innovative ideas across the organisation to optimize the processes and procedure which inturn decrease the cost of operational expenditure.
Handled more than 1500 bioequivalence studies as principal Investigator and part of different therapeutic areas clinical trials as sub investigator submitted to different regulatory agencies like USFDA, EMEA, Brazil, Australia, MHRA Canada and South Africa & DCGI.
Extensive exposure in handling clinical studies/ project management for different regulated markets such as US FDA, European etc. Encouraged collaboration between budget management teams and executive leadership to develop financial plans to support company strategic initiatives. Optimized balanced management of studies with available resources by applying Micro level planning of studies. Handling different regulatory audits on one to one basis with the agencies like USFDA, ANVISA, WHO, MHRA< BFram, AGES, ANSM etc. Handling regulatory deficiency letters/ or requests for additional information posed by different regulatory agencies, pertaining to bioequivalence studies and Patient based Pk Studies
Overview
18
18
years of professional experience
8
8
years of post-secondary education
Work History
Co-Founder & COO
Solvitall Research Labs Private Limited
01.2023 - Current
- Manages overall operations of Solvitall Labs
- Translate the organization's strategic vision into actionable operational plans
- Provide leadership and direction to various departments and functions to ensure alignment with the company's objectives
- Drive a culture of continuous improvement and operational excellence
- Identify opportunities for process improvements and efficiencies across all areas of the organization
- Implement strategies and initiatives to streamline workflows and reduce operational costs
- Monitor and evaluate the effectiveness of operational processes
- Manage budgets, allocate resources, and optimize resource utilization to achieve operational goals
- Oversee workforce planning, talent acquisition, and talent development efforts
- Ensure the availability of necessary resources, technology, and equipment to support operations
- Establish and maintain standards to deliver high-quality services
- Monitor and assess customer feedback and satisfaction to drive improvements
- Ensure compliance with relevant quality and regulatory standards
- Define and monitor key performance indicators (KPIs) to measure and track operational performance
- Analyze data and trends to make informed decisions and adjustments to strategies
- Collaborate with CEO and other senior leaders to develop short-term and long-term operational plans that align with the organization's strategic objectives
- Implement strategies to support growth, expansion, or diversification efforts
- Identify operational risks and develop risk management strategies and contingency plans
- Ensure compliance with legal, regulatory, and statutory requirements
- Build and lead a high-performing team of senior leaders and managers
- Foster a collaborative and results-driven culture within the organization
- Mentor and develop talent to support leadership succession planning in each department
- Serve as a liaison between the CEO and other organizational departments
- Communicate the Company vision and priorities to the operational teams.
Associate Vice President-Clinical Operations
Par Biosciences Pvt Limited, Endo International Company
07.2015 - 12.2022
- Overall management of clinical, Pharmacokinetics, regulatory and administration department pertaining to clinical operations
- Supervising a team of over 50 people in different disciplines like study participant recruitment, Medical writing Team, Study execution, Pharmacokinetics team
- Manages study operation plan including project timelines and quality of deliverables throughout the life cycle of the study conduct
- Serve as subject Matter Experts in handling regulatory audits and sponsor audits
- Implemented new business processes, strategies, identified issues, proposed strategies to manage implications and risks on studies Execution
- Review and refines Clinical operational Plans including the study Initiation plan, IP Management plan, Retention samples plan, AE and SAE management plan, study monitoring Plans and other Micro level planning for execution of studies
- Provides input, review and revision of protocols, case report forms, training materials, project specific plans and study reports
- Participates in selection of vendor/resources for assigned studies
- Maintains frequent and meaningful contact/review with Team to assess performance and provide guidance as needed
- Serves as Medical/scientific expert to internal/external stakeholders: develops and executes medical plan and procedures across the sites
- Established future-state regulatory intelligence and compliance strategies to predict and respond to emerging global requirements well in advance of need
- Involved in Study Initiation with proper training and streamlined processes as per applicable regulatory guidelines/in House SOP
- Close Monitoring of activities from Medical Writing, Execution Team, Clinical Operations, Compliance and risk management of study Conduct
- Management of Outsourcing Vendor effectively
- Encouraged collaboration between budget management teams and executive leadership to develop financial plans to support company strategic initiatives
- Coordinates internal and external Clinical Development Activities of all Team members involved in the design and conduct of assigned Clinical Studies
- Contributes to relevant study documentations including Clinical Protocols, statistical Analysis plan, Clinical Study reports as well as operational plans
- Develop and manage study timelines (including recruitment) and may develop and manage program timelines
- Participates in selection of subjects/Study participants for clinical studies
- Proactively identifies project risk and resolves with some supervision
- Oversees study activities by adherence to pertinent regulations through review of monitoring reports, CQA-GCP reports, communications with study site personnel, CRA and other CRO/designee personnel
- Leads ongoing review of data to ensure GCP and Oversees the submission of trial-related and essential documents to Trial Master File
- Identifies and provides solutions to clinical Trial issues and/or risks
- Represents Clinical Operations in cross-functional initiatives as assigned by management
- Provides input into non-project related activities and development of department processes, procedures, and guidelines as requested
- Designing studies and submitted studies for different regulatory agencies like USFDA, ANVISA, WHO, BFram, AGES, MHRA, ANSM etc.
Head – Clinical Trial and Principal Investigator-Bioequivalence studies
Micro Therapeutics Research Labs (P) Ltd
08.2010 - 06.2015
- Overall management of clinical, pharmacokinetic and statistical, project management, regulatory and administration department
- Principal investigator for the bioequivalence studies
- Handling team of clinical investigators for Bioequivalence and clinical trial department
- Project management from scratch to review & submission of study reports
- Designing studies and submitted studies for different regulatory agencies like USFDA, ANVISA, WHO, BFram, AGES, ANSM etc
- Ensuring that all the study documents like study protocol, reports and study activities like study monitoring, IMP handling etc
- Are carried out as per the regulatory requirements
- Submitting protocols to regulatory agencies prior to the start of the study and discussing with them to finalize the study design
- Reviewing and maintaining study master files and regulatory documents
- Handling different dosage forms like solid oral, semi-solid oral, topical, injectables
- Closely worked with bioanalytical department to ensure that the methods are developed, validated and study subjects samples have been analyzed as per the requirements
- Experienced in handling DCGI, ANVISA, USFDA, AFSSAPS audits and got the approval
- Responsible for DCGI application for BE NOC, DGFT and Narcotic drug license for the sample export
- Handling different regulatory agencies deficiency letters
- Extensive pilot study data review to understand the study outcome and designing the pivotal study accordingly for the in-house products
- Reviewing and submission of bio study reports to different regulatory agencies as per the requirement
- Ensuring the archival of documents, IMPs as per the regulatory requirements
- Ensured proper handling of IMPs for the bio studies and clinical studies
- Generated SOPs for different clinical department activities
- Handling institutional ethics committee (IEC) and reported AE/SAE to IEC, sponsor
- Trained ethics committee members for GCP/Schedule Y.
Emergency Physician/Clinical Research Investigator/Head-Clinical Research
Lifeline Multispecialty Hospitals
12.2005 - 08.2010
- Handled, assisted clinical studies in patients in different therapeutic areas like Oncology, Gastroenterology, Post-surgical Trial, Dermatology, etc
- Point of contact for the clinical study related activities for the sponsor
- In charge of the clinical research wing and managing a team of clinical research professionals
- Ensured the proper management of investigational medicinal products for the clinical studies
- Involved in informed consent process, documentation of CRFs, etc
- Ensured adherence of clinical trial conduct to study protocol, global standard operating procedures, and regulatory guidelines
- Review and refines Clinical operational Plans including the study Initiation plan, Investigational IP, Management plan, Retention samples plan, AE and SAE management plan, study monitoring Plans, and other Micro level planning for the execution of studies
- Established and maintained communications with sponsors and ethical committee
- Conducted disease management surveys and patient screening programs
- Handled and reported adverse drug events and serious adverse drug events.
Education
Bachelor of Medicine and Bachelor of Surgery (MBBS) - Medicine
Tirunelveli Medical College (Tamilnadu Dr MGR Medical University)
Kanchipuram 08.1999 - 04.2005
Master of Health Science (Diabetology) - Diabetology
Annamalai University
Tamilnadu 02.2012 - 07.2014
Skills
Adapt in building excellent rapport to stakeholders
undefinedConferences Workshops
- Attended training and certification from American Heart Association on Advanced Cardiac Life support and Basic Life Support.
- Attended Six months training in Diagnostic Ultrasound Imaging from Selvi School of Sonology.
- Participated in Pre conference Workshop on 'Preparing for GCP Site Inspections' by Indian Society for Clinical Research (ISCR) in Feb 2019.
- Certified on Good Clinical Practice (GCP), conducted by Cliantha Research Limited, Held at Chennai in Aug 2018
- Participated in Workshop on 'Data Review Process' conducted by Par Biosciences Mar 2018
- Speaker in panel discussion conducted by CDSCO, Hyderabad Zone in Mar 2014 (Topic-Clinical trial Approvals in India and Audio Video Counselling)
- Guest Speaker in workshop conducted by T.S.Narayanaswami College in Sep 2013.
- Guest speaker in workshop conducted by Clinedu Institute at Madurai Pharmacy College in Jun 2013.
- Workshop on GCP in the context of BA/BE conducted by Arkus Clinical Trial Support Solutions, Chennai in Apr 2013.
- Participated in 'Leadership Workshop' conducted by Franklin Covey during the year 2012
- Participated in 'Workshop on Linguistic Programming' conducted by New Life Catalyst during the year 2012
- Attended two days workshop on Pharmacokinetics and Biostatistics by Pharma edge at Balaji Medical College, Chennai in 2011
- Hands on training in Clinical Data management and Pharmacovigilance by Lambda Research Labs at Mumbai in Sep 2007.
- Investigator Workshop on electronic data capture, conducted by Bristol Mayor Squib, held at Goa in Jun 2007.
- Investigator workshop on Good Clinical Practice (GCP), conducted by Quintiles, held at Chennai in Jan 2006.
- Certified on ICH-GCP conducted by ICON CLINICAL RESEARCH held at Bangalore.
- Attended two days workshop on Pharmacokinetics and Biostatistics by Pharma edge at Balaji Medical College, Chennai in 2011.
- CME programmes with Lifeline Multispecialty Hospitals, Chennai.
Timeline
Co-Founder & COO
Solvitall Research Labs Private Limited
01.2023 - Current
Associate Vice President-Clinical Operations
Par Biosciences Pvt Limited, Endo International Company
07.2015 - 12.2022
Master of Health Science (Diabetology) - Diabetology
Annamalai University
02.2012 - 07.2014
Head – Clinical Trial and Principal Investigator-Bioequivalence studies
Micro Therapeutics Research Labs (P) Ltd
08.2010 - 06.2015
Emergency Physician/Clinical Research Investigator/Head-Clinical Research
Lifeline Multispecialty Hospitals
12.2005 - 08.2010
Bachelor of Medicine and Bachelor of Surgery (MBBS) - Medicine
Tirunelveli Medical College (Tamilnadu Dr MGR Medical University)
08.1999 - 04.2005
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