Pallavi Phopale
Senior Manager Clinical Research
Thane
Summary
Quality-driven and customer-focused clinical operations expert with over 19+ years of experience in the clinical research industry. Expertise in client management in Functional Service Provider (FSP) department of multinational CRO with an upbeat positive attitude and successful track record of building and cultivating business critical relationship with premium clients. Skilled project manager with more than 7 years of onsite monitoring experience. Adept in managing phase II, III, and IV trials across various therapeutic areas such as Respiratory, Gynecology, Oncology, Cosmetology, Gastroenterology, and COVID-19 Prowess in leading team of 25+ members in roles including CTA, CRA, Lead CRAs, CTMs, and Project Managers.
Overview
18
18
years of professional experience
Work History
Senior Manager Clinical Operations
ICON PLC
09.2026 - Current
- Provide leadership to the Clinical Operations team at the country level.
- Monitor and improve key performance and quality indicators (KPIs/KQIs), utilization, and customer satisfaction.
- Provide effective staff management support to ensure high performance of each team, quality work, and strong team engagement.
- Act as a counterpart and escalation point regionally to the customer clinical operations lead.
- Carry out key leadership responsibilities, including performance assessments, goal setting, and development planning.
- Empower and coach the clinical operations team to achieve their objectives, and grow professionally.
- Oversee and manage resource allocation to align project teams with client needs, and contractual expectations.
- Ensure operational excellence through clinical oversight and continuous process improvement.
- Foster a culture of accountability, collaboration, and innovation within the team.
- Support business growth by aligning team capabilities with client expectations, and organizational goals.
- Write/review and ensure implementation of Corrective Actions/Preventative Actions as an outcome of audits.
- Maintain inspection readiness and compliance with internal and external standards.
- Lead the development and scaling of high-performing clinical operations teams based on business and client requirements, including building teams from the ground up for major pharmaceutical clients.
- Drive workforce planning and talent acquisition by identifying resource requirements, hiring qualified clinical professionals, and optimizing resource deployment to support business objectives.
- Lead the study and allocate CRAs based on study requirements, workload, therapeutic experience, competency, and business priorities.
- Lead employee engagement, coaching, mentoring, career development, succession planning, and retention initiatives to sustain a high-performing clinical operations team.
- Establish and implement risk management and mitigation strategies to proactively address operational challenges, and ensure business continuity.
- Plan and conduct CRA Quality Visits and Quality Deep Dives to identify quality gaps, performance trends, and improvement opportunities.
- Review monitoring visit reports with CRAs, and provide guidance to improve monitoring quality, compliance, and study execution.
- Partner with project teams and sponsors to identify study risks, and implement mitigation plans to ensure the delivery of key milestones within agreed timelines.
- Lead and participate in governance meetings with sponsors, project teams, investigators, and internal stakeholders to align on study progress, risks, resources, and deliverables.
- Manage employee performance processes, including goal setting, performance reviews, development plans, compensation inputs, bonus recommendations, and promotion nominations.
- Collaborate with Clinical Operations, Project Management, Resource Management, Quality, Training, Finance, and other functions to achieve organizational and client objectives.
Manager Clinical Operations
ICON PLC
04.2021 - 08.2026
- Provide strategic and operational leadership for clinical operations teams, ensuring the delivery of clinical programs in accordance with organizational objectives, client expectations, quality standards, timelines, and applicable regulations.
- Lead the development and scaling of high-performing clinical operations teams based on business and client requirements, including building teams from the ground up for major pharmaceutical clients.
- Acted as the primary India Point of Contact (POC) for FSP engagements, managed client relationships, operational governance, resource planning, performance, and issue escalation.
- Provide end-to-end oversight of country-level clinical operations, including resource forecasting, study allocation, recruitment, onboarding, workload management, and performance monitoring.
- Develop strategic resource plans aligned with business forecasts and Strategic Resource Targets, ensuring optimal resource utilization and capacity.
- Drive workforce planning and talent acquisition by identifying resource requirements, hiring qualified clinical professionals, and optimizing resource deployment to support business objectives.
- Monitor team performance through defined KPIs, quality metrics, productivity measures, and study deliverables, ensuring timely identification and resolution of performance or operational risks.
- Lead employee engagement, coaching, mentoring, career development, and retention initiatives to develop and sustain a high-performing clinical operations team.
- Established and implemented risk management and mitigation strategies to proactively address operational challenges and safeguard business continuity.
- Oversee CRA monitoring quality, competency assessments, performance, workload, and compliance with study-specific and organizational requirements.
- Plan and conduct CRA Quality Visits and Quality Deep Dives to identify quality gaps, performance trends, and improvement opportunities.
- Review monitoring visit reports with CRAs, and provide guidance to improve monitoring quality, compliance, and study execution.
- Monitor critical clinical trial milestones and deliverables, including Site Initiation Visits (SIVs), recruitment, patient enrollment, monitoring timelines, and study KPIs.
- Partner with project teams and sponsors to identify study risks, and implement mitigation plans to ensure the delivery of key milestones within agreed timelines.
- Support sponsor audits, and ensure timely implementation and closure of Corrective and Preventive Actions (CAPA).
- Lead and participate in governance meetings with sponsors, project teams, investigators, and internal stakeholders to align on study progress, risks, resources, and deliverables.
- Establish and implement role-based operational hubs and customized FSP operating models based on client requirements.
- Provide clinical operations expertise and strategic recommendations to clients and internal stakeholders to address operational challenges, and improve delivery.
- Provide input into contingency planning, and assess the potential operational, resource, timeline, and budget impact of project risks and changes.
- Manage employee performance processes, including goal setting, performance reviews, development plans, compensation inputs, bonus recommendations, and promotion nominations.
- Identified and implemented process improvements through the review of SOPs, workflows, and operational trends to enhance efficiency, quality, and client satisfaction.
- Collaborate with Clinical Operations, Project Management, Resource Management, Quality, Training, Finance, and other functions to achieve organizational and client objectives.
- Promote a culture of quality, accountability, continuous improvement, collaboration, and patient-focused clinical trial delivery.
Associate Manager
IQVIA PLC
08.2019 - 04.2021
- Responsible for overall Timelines, Quality, and Productivity of the project.
- Supporting team in achieving the KPIs thereby aligning with the organization's goal.
- Perform quality reviews and compliance checks on the parameters outlined in quality oversight plan.
- Manage feedbacks/escalations to monitor study deliverables and mitigate risk operationally.
- Manage staff per organization policies and applicable regulations. Responsibilities include planning, assigning and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relation issues and resolving problems. Participate in the selection and onboarding process for new staff by conducting candidate review and participating in interviewing process.
- Participate in the allocation of resources to the projects by ensuring assignments are appropriate to staff experience and training; organizing staff including shift patterns and no. of staffs required to meet demand
Lead CML (Centralized Monitoring Lead)
IQVIA PLC
11.2017 - 07.2019
- Performing Functional Lead responsibilities for assigned project deliverables for specific customers or projects. Managing project-specific and process-related challenges.
- Acting as a POC for all internal and external stakeholders.
- Overseeing CML and CM (central monitor) deliverables, as applicable.
- Managing team's performance related challenges and escalates as applicable.
- Assuring alignment of deliverables; based on time zone/experience/expertise and project needs.
- Providing a project status report/update to internal and external stakeholders as applicable.
- Providing oversight on clinical deliverables on assigned projects.
- Attending kick-off meetings, weekly team meetings and client meetings as needed or requested.
- Preparing and/or overseeing Clinical Operations Plan (COP) and study specific documents including Monitoring Plan, Study Data Validation (SDV) plan and Study Reference Manual / Guidelines / Instructions, Annotated Site Visit Report and Letter Templates, Scripts for monitoring visits as applicable.
- Managing Project Resources (Clinical Research Associates (CRA/Clinical Trial Assistant (CTA) and Centralized Monitoring Team)
- Overseeing the IP Management for assigned study to identify risks and proposed mitigation.
- Acting mentor/coach for junior CMS staff
- Conducting periodic review of site level Key Risk Indicators and historic site performance according to Central Monitoring Plan and early identification of site level risk / issues occurring during study conduct.
- Developing and managing training plan for project team
- Managing and coordinating efforts of cross functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure complete and accurate documentation of all the study-specific tools and templates and keep project audit ready. Process quality and audit initiatives by identifying impacted areas, providing root causes and implementing of corrective and preventive action.
- Acting as a 'Subject Matter Expert' (SME).
- Tracking and follow up on non-recruiting sites, follow appropriate escalation processes. Support Clinical Lead to update operational group plans and related documents throughout the study.
- Closely working with CRA, CTA, CM and CAS to ensure that study systems are updated including patients visits in Clinical Trial Management System (CTMS)
- Verifying approving investigator payment batch to release payments
- Trial Master File Management
- Protocol Deviation Management
Deputy Project Manager
Cipla Pvt.Ltd
04.2015 - 11.2017
- Develop project management plans together with oversight of database and study maintenance.
- Serve as primary project contact with vendors to ensure communication is maintained and reporting and tracking schedules are adhered to through study execution phase.
- Manage study issues and obstacles and ensure compliance with standard processes, policies and procedures.
- Maintain appropriate communication with relevant functional areas.
- To anticipate and proactively solve study-related clinical site issues as they occur and initiate, recommend and communicate corrective actions as indicated. Use functional expertise and exercise good judgment in seeking appropriate guidance and ensure that follow-up to any and all corrective action is taken at the clinical site and is properly documented.
- Provide input for the development of proposals and study documents for clinical studies and manage project budgets.
- Forecasting budget for assigned studies and keeping a track on planned actual expenditure for assigned studies to ensure the study budgets are on track.
- Vendor management.
- Forecasting study milestones of assigned clinical trials and accomplishing deliverables as per the planned milestones.
- Overlooking work of CRAs and their site visit repots.
- Training of CRAs. (off site as well as on site)
- Identification of potential investigators.
- Designing of clinical trial Standard Operating Procedures.
- Overlooking registration of clinical trials on Clinical Trial Registry - India (CTRI).
Senior Clinical Research Associate
Cipla Pvt.Ltd
03.2011 - 03.2015
- Identification of potential investigators and clinical sites; conducting site selection visits, site initiation, investigators' meetings for training the investigators and study team as per regulatory requirements.
- Provide training to investigators and study team on protocol, ICF, CRF and other study documents and ensuring compliance to the protocol and applicable regulatory requirements.
- Overlooking registration of clinical trials on CTRI.
- Designing of clinical trial Standard Operating Procedures.
- All below listed Clinical Research Associate activities.
Clinical Research Associate
Cipla Pvt.Ltd
06.2008 - 03.2011
- Site identification, feasibility evaluations, selection, initiation, on-site monitoring, and closeout as per requirement.
- To perform site monitoring and report preparation.
- Negotiate and finalize site budgets.
- To update all sites on study progress.
- Trained site personnel on various guidelines for clinical trials.
- To assist in organizing and conducting investigators' meetings.
- Prepare and execute CTAs.
- Assisting in RA and EC submission.
- IP and site supply management.
- Verification of translated and back-translated ICDs, subject diaries, and patient information materials.
- To maintain the Trial Master File throughout the study period.
Education
Master of Science - Clinical Research
Cranfield University
United KingdomBachelor of Science - Microbiology And Biochemistry
Mumbai University
Mumbai, IndiaSkills
- FSP team management across the six global leading multinational pharmaceutical organizations
- Team scaling strategies (Hub creation)
- Client relationship management
- Project and line management
- Resource allocation
- Risk-based monitoring
Accomplishments
- ICON ISPIRE AWARD*2
- Awarded for managing and expanding the Pfizer as well as Novartis program.
- STANDING OVATION AWARD*2
- Awarded by IQVIA for successfully driving close out initiative.
Additional Information
POSTER PRESENTATIONS and AUTHERSHIP (International)
· Comparison of HFA salmeterol-fluticasone (SFC) combination when given through breath actuated inhaler (BAI) and pressurised meter dose inhaler (pMDI) in patients with moderate-to-severe asthma, presented in European Respiratory Society (ERS) 2013, Barcelona Spain
· Efficacy and safety of nebulized formoterol/budesonide (FB neb) compared with formoterol/budesonide pMDI (FB pMDI) in patients with severe to very severe COPD, Presented in Asia Pacific Society of Respirolgy (APSR) 2014 Bali Indonesia.
POSTER PRESENTATIONS AND AUTHERSHIP (NATIONAL)
· Efficacy and safety of nebulized formoterol/budesonide (FB neb) compared with formoterol/budesonide pMDI (FB pMDI) in patients with severe to very severe COPD, presented in National Conference On Pulmonary Disease (NAPCON) 2014 Agra
· Evaluation of efficacy and safety profile of fluticasone/formoterol (FF) combination verses budesonide/formoterol (BF) combination administered through a pressurized metered dose inhaler (pMDI)in patients with moderate to severe persistent asthma: a randomized controlled trial, presented in NAPCON 2014 Agra
Accomplishments
ICON ISPIRE AWARDAwarded for managing and expanding the Pfizer as well as Novartis program.
STANDING OVATION AWARD *2Awarded by IQVIA for successfully driving close out initiative.
IQVIA STAR CML AWARDAwarded by IQVIA for successfully driving assigned project.
CIPLA- APPLAUSE *3Awarded by CIPLA twice for remarkable contribution and successful project completion for two PHASE III projects.
Personal Details
- Date of Birth: 16/09/1985
- Nationality: Indian
- Marital Status: Married
Extra
Classical Dance – Completed Grade 3 with distinction; currently pursuing Grade 4, reflecting strong proficiency and a deep passion for the art form.
Timeline
Senior Manager Clinical Operations
ICON PLC
09.2026 - Current
Manager Clinical Operations
ICON PLC
04.2021 - 08.2026
Associate Manager
IQVIA PLC
08.2019 - 04.2021
Lead CML (Centralized Monitoring Lead)
IQVIA PLC
11.2017 - 07.2019
Deputy Project Manager
Cipla Pvt.Ltd
04.2015 - 11.2017
Senior Clinical Research Associate
Cipla Pvt.Ltd
03.2011 - 03.2015
Clinical Research Associate
Cipla Pvt.Ltd
06.2008 - 03.2011
Bachelor of Science - Microbiology And Biochemistry
Mumbai University
Master of Science - Clinical Research
Cranfield University