Summary
Overview
Work History
Education
Skills
EXTRAMURAL ENGAGEMENTS
Accomplishments
Timeline
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Pallavi Phopale

Pallavi Phopale

Manager Clinical Operations
Thane

Summary

Quality-driven and customer-focused clinical operation’s expert with over 16 years of experience with clinical research organizations and pharmaceutical industry. Expertise in project management with more than 7 years of onsite monitoring experience. Skilled 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

16
16
years of professional experience

Work History

Manager Clinical Operations

ICON PLC
04.2021 - Current
  • Overall responsible for planning & execution of clinical project and ensuring project team delivers quality outcome within timeline.
  • Planning resource demand per requirement and align on Strategic Resource Targets.
  • Assigning CRAs to studies and track their workload.
  • Tracking CRA monitoring competency and assessment
  • CRA Quality Visit Planning and Perform Quality Deep Dive
  • Monitoring all key trial deliverables and KPIs and take necessary actions accordingly
  • Reviewing monitoring visit report and discuss it with CRAs
  • Participating in recruitment and patient target meetings and support making strategies for patient recruitment
  • Participating in audit and inspection processes.
  • Organizing and/or participating in Sponsor/Project team/Investigator meetings
  • Manage and develop employees to ensure high-quality work performance and retention of high-quality employees.
  • Developing plans to support the growth and career development of assigned Clinical Operations employees as well as manage the delivery of quality performance in line with their job description.
  • Assisting CRAs in site selection, site initiation activities and ensuring tasks are done within timeline.
  • Responsible for managing the performance of staff, including providing input into salaries, bonuses as well as nominations for promotion.
  • Providing guidance/insight into aspects of clinical operations as well as contingency planning to accommodate the project while identifying potential impacts on the budget
  • Identifying and implementing process improvements through review of clinical operations SOPs, and processes; recommending improvement plans to senior management

Associate Manager

IQVIA
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; organize staff including shift patterns and no. of staffs required to meet demand

Lead CML (Centralized Monitoring Lead)

IQVIA
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
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 close out as per requirement.
  • Negotiate & finalize site budgets.
  • To assist in organizing and conducting investigator’s meetings.
  • IP and site supply management.
  • Verification of translated and back-translated ICD’s, subject diaries and patient information materials.
  • Prepare and execute CTAs
  • Assisting in RA and EC submission
  • Site personnel training on various guidelines as per industry standards of clinical trials.
  • To perform site monitoring and report preparation.
  • To update all sites on study progress.
  • To maintain the Trial Master File throughout study period.

Education

Master of Science - Clinical Research

Cranfield University
United Kingdom
04.2001 -

Bachelor of Science - Microbiology And Biochemistry

Mumbai University
Mumbai, India
04.2001 -

Skills

  • Resource management

    • undefined

    EXTRAMURAL ENGAGEMENTS

    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 AWARD

      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.

      IQVIA STAR CML AWARD

      Awarded by IQVIA for successfully driving assigned project.

      CIPLA- APPLAUSE *3

      Awarded by CIPLA twice for remarkable contribution and successful project completion for two PHASE III projects.

    Timeline

    Manager Clinical Operations

    ICON PLC
    04.2021 - Current

    Associate Manager

    IQVIA
    08.2019 - 04.2021

    Lead CML (Centralized Monitoring Lead)

    IQVIA
    11.2017 - 07.2019

    Deputy Project Manager

    CIPLA
    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

    Master of Science - Clinical Research

    Cranfield University
    04.2001 -

    Bachelor of Science - Microbiology And Biochemistry

    Mumbai University
    04.2001 -

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