Page * of *

SAPNA RAHUL GHAITADKAY

(NEE: SAPNA KISHORE KHADE)

Contact: +91-982*******

E-Mail: ad35dj@r.postjobfree.com

Professional Summary

.

Pursed Bachelor in Pharmacy followed by Diploma in Marketing Management from Wellingkar’s Institute.

More than 18 years’ work experience, of which more than 16 years in Clinical Research in varying roles within Clinical Operations, Project Management and Line Management.

Therapeutic experience in Gastroenterology, Oncology, Ophthalmology, Respiratory, Neurology, Dermatology/Immunology and Cardio metabolic studies.

Experience of Phase II, III, IV, RWE and Bioequivalence studies for Global and Indian sponsors for US FDA submissions.

Skilled in Clinical operations activities from Proposal to Study close out activities including Project Management and Vendor Management.

Experience Snapshot

Dec 2021- Ongoing with Parexel International India, as Clinical Operations Manager

Manage and oversee team activities including appropriate resourcing of staff, staff assignments, quality control, and efficiency of project deliverables.

Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of their project in line with the project plan by conducting quality checks of deliverables.

Meet and aim to exceed client expectations by recruiting, retaining, and developing a skilled, experienced, and motivated team.

Support staff to improve their efficiency and effectiveness at prioritizing work and improving performance evidenced by the work produced, client feedback, audit results, and QC measures.

Serve as an ongoing liaison with the Project Team, Sponsor, and management regarding the performance of direct reports.

Provide technical support to staff to ensure that they have the required knowledge to fulfill their duties.

Monitor performance by close interaction with project leadership/functional leadership and ensure that ongoing/revised project documentation and correspondence are accurate and complete.

Provide consultation, facilitate metrics collection, and develop action plans in conjunction with Management/ Project Leadership/ Leads to keep the project on time and within budget.

Responsible for own assignments as a project team member and ensuring high quality and timely delivery of own deliverables, generating study-specific status reports for study teams, Sponsors, and/or management, and attending project team meetings as required at the project level.

Manage and develop the staff to ensure their performance meets and or exceeds both the business and their personal goals/objectives through training, mentoring, and allocating staff according to their ability.

Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.

Page 2 of 8

Mar 2020- Oct 2021 with Icon Clinical Research, as Central Clinical Trial Manager

To effectively review trip reports as per Protocol and ICON and Sponsor SOPs and to ensure the quality of reports are of the highest standards, errors are minimized and that issues are escalated as appropriate

To follow up on action items and protocol deviations and to be a liaison between CRA, CTM and PM for timely resolution of issues.

To act as an extension of the CTM/CTM team for the specific purpose of trip report review.

To observe and escalate safety trends in patients as identified in trip reports Dec 2017- Mar 2020 with SIRO Clinpharm Pvt Ltd., as Assistant Manager-Clinical Operations. Job Role:-

Line Management of Clinical Research Associate (CRA), Senior CRA and Clinical Trail Assistants.

Project Experience:

PM for MBC Study (Bioequivalence) for IND submission to US FDA.

PM for RWE study on Endocrine Disorder.

PM for an ongoing Bioequivalence study on COPD.

Assigned as CTL for an ongoing Phase IV Study on Infectious disease

Assigned as ongoing CTL for Phase IV study on HCC. Major Activities:

Work collaboratively with Project Manager (PM) or as a Project Manager to coordinate the execution of clinical deliverables and study timelines by setting up clinical tools and processes for the study team.

Help with the study setup and follow up study activities by ongoing tracking and review of study progress according to scope of work.

Provide ongoing training and support to the clinical team through establishment of study tools and training materials, frequent team meetings, and regular communication.

Ensure high performance and efficiency of the clinical team through co-monitoring/accompanied site visits and ongoing mentoring of CRA team.

Contribute to the risk management plan from a clinical perspective and coordinates clinical issue escalation and resolution with the Line Manager.

Identify quality issues within the study through regular review of the clinical team communications including site communications, monitoring visit reports, data flow information and Quality Assurance Audit findings

To provide regular guidance to personnel involved in a clinical trial team

Clinical trial and regulatory expertise in development and application of procedures, documents, training materials, communications, and/or tools.

Ongoing review of procedures and practices for maintenance.

Resolve queries (both internal and external) relative to current processes, regulatory guidelines, and/or quality (including policies and procedures, ICH-GCP and applicable regulations).

Implement self-grooming and training initiatives.

Ensure regulatory compliance.

Meet or exceed the planned metrics and expectations of sponsors/team/project manager.

Undertake the delegation of duties within the organization.

Regular participation in project/departmental meetings. Line Management

Manage and direct the efforts of CRAs/CTAs and recommend personnel actions including, but not limited to performance management, scheduling and work assignments, disciplinary action, promotions etc.

Page 3 of 8

Define and communicate job descriptions, core competencies, and performance standards and expectations.

Assist in the development and implementation of reward and recognition programs in order to achieve optimal employee satisfaction and retention.

Coordinate regular team meetings (at least with the frequency of two meetings per month) and ensure team is kept abreast of departmental and organizational activities, goals, and policies.

Establish accurate and consistent productivity expectations and revise as needed. May 2015- Jun 2017 with Novartis Pharmaceuticals Pvt. Ltd., as Clinical Operations Specialist

(COS)

Job Role: Worked on Biologic for PsA and Natriuretic peptide based referral of CHF patients Major Activities:

First point of contact for day to day operations, ensure appropriate and timely escalations with corrective action.

Plan and conduct Project kick off meetings within the organization and Vendors.

Conduct and Manage weekly project update meetings within the project team and the vendors.

Share presentations for the Monthly Project status update and Monthly Budget review status to the Management.

Involved in preparation and/ or review of project specific plans and documents including Protocol, ICF (Global, Country and Site), Study Logs and forms, Newsletters..etc.

Closely review and Track vendor KPI’s, payments and related documents.

Train Vendor CRA on in-house system and processes.

Plan and Oversee Investigator’s Meeting preparation and conduct including presentations.

Maintain FAQ and Learnings for the assigned projects/ activities.

Work closely with internal stakeholders like Regulatory, Safety, Drug Supply and Finance to ensure smooth conduct of the study.

Routine review and Follow up on open eCRF queries through Central monitor. Awards and Recognition: (Documents available on request). o Applause on the handling of new systems/ processes for an End-to-End Study setup. o Applause for support in achieving contractual activities for assigned Study. o Above And Beyond Award for Global Initiative.

o Certificate of appreciation towards poster presentation done for the department. Trial logistics:

Handled team of 20-25 CRA’s for trainings, project related activities. etc.

Worked closely with Central Monitoring Team, Data Management Team and Drug supply team.

Involved in the weekly update calls with the Vendors like CRO, Central Lab and other Line functions.

Review of Visit Reports, follow up letters and contact reports as per KPI.

Responsible for the set-up and maintenance of trial(s) in Clinical Trial Management Systems: Trial timelines and key milestones, enrolments, sites information as appropriate (i.e. ClinAdmin); generate enrolment curves to support reporting. Prepare and present assigned study status in the monthly Operations review meeting.

Ensure that the Project files are up-to date in CTMS (all study related documents on top of protocol and amendments including DSM, DRA, Safety. etc.)

Review Country and HQ TMF, ensuring all key documents are present and filed as appropriate. Final Protocol Packages availability.

Ensure availability of trial material for country management /sites (i.e. IV bags, fridge, laptops, etc) including tracking of rented material.

Support Trial Manager in keeping an overview of drug availability at site level in collaboration with country management and drug supply management.

Page 4 of 8

Support Trial Managers in meeting set-up, minutes, running reports from systems, draft trial documentation like study logs.

Trial Management:

Prepare and finalize Total Trial Grant in close association with different line functions and the PM to ensure accurate planning, tracking and reporting of trial(s) budget. Prepare and present the assigned study status in the monthly budget review meeting.

Responsible for review of site visit related documents like confirmation letter, visit report and follow up letters.

Responsible for evaluation of country level budget/ Grant Plan estimates and the negotiation of investigators fees and country related trial costs and monitor status of final invoices.

Review of Site visit reports and FU letter, ensure open issues are closed as per KPI.

Vendor coordination: Support trial Manager in the set-up and coordination of third-party vendors (i.e. CRO, Central Lab, DSM, iRT, DM, ePRO Vendors, investigators meeting organization.. etc.) ensuring all information, documentation and materials are in place for the trial start.

Responsible for effective and smooth workflow between different stakeholders (i.e. third-party vendors and country/sites management).Follow-up with vendors on day-to-day operations (recruitment reports, delivery of study kits, etc.)

Non project Initiatives:

Involved in training mentees/ new joiners.

Active involvement in Global initiative and was awarded beyond- Gold. (Upgradation of CTMS within Novartis). Activities involved sharing requirements, review of system/ UAT, review of training material and training slide decks.

Recently completed training on Project Management Fundamentals.

Actively involved in the review and updating of Storyboards based on the process to be followed based on SOP, WP and FRM’s.

Active involvement in the CSR- RAINBOW.

Member of Diversity and Inclusion Team.

Part of Monthly Birthday Celebrations Team.

July’ 13- April’ 15 worked as a Freelancer with Ektya Clinical and Sense CR.

Support creation of Site SOP’s with SenseCR.

Supported Clinical Operation Activities.

April’ 12- July’ 13 with PPD Pharmaceuticals Development Pvt. Ltd., Mumbai as Senior Clinical start up Specialist (Sr CSS- redesigned to Country Approval Specialist) Job Role: Worked on multiple indications including Dermatology, Neurology, Respiratory, Cardio Vascular etc. for Feasibility and Site Start-up activities.

To review and/or negotiate all required essential regulatory documents for completeness and readiness as required for site IP Approval and ensure that ongoing awareness of IEC/IRB submission deadlines, meeting dates and procedures are communicated to start up team members as appropriate.

To negotiate with difficult investigators, research nurses and site staff to reach desired resolution.

To identify activities along the critical path toward individual site IP approval and completion of all site start-up activities for a study.

To effectively analyze project specific data, systems and deliverables to ensure accuracy and completeness.

To extract pertinent information from all study documents such as protocols, informed consents, contracts, etc.

To review and approve draft or IRB approved informed consent form document (ICF) using the appropriate ICF checklists to document the review.

Work independently or with minimal supervision with multiple sites simultaneously and handle multiple tasks effectively while keeping up with rapid changes in priorities without loss of efficiency Page 5 of 8

Demonstrated understanding of applicable ICH Guidelines, FDA Good Clinical Practices, PPD and client Standard Operating Procedures/Working Practice Documents/PWIs.

Conduct Feasibilities within the allocated time.

Oversee site start-up for assigned projects according to timelines and quality standard.

Assists with coordination of the flow of information between PPD teams, clients, or functional departments involved in site start-up.

Develops plans/guidelines for project implementation using PPD tools.

Monitors and analyses project status to ensure successful progress and completion of all assigned projects and provide metrics to management with Risk identification and contingency planning.

Collaborates with PPD teams to manage all financial and contractual aspects of the studies related to site start-up.

Works with Site Start-up team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets.

Ensures consistency and application of required and agreed processes within the Site Startup team.

Identifies and escalates issues appropriately/pro-actively.

Initiate, develop and execution and dissemination of study-related progress reports. Significant Highlights:

Work closely with the Clinical Operations Team including the Clinical Operations Manager, Project Managers, Site Monitors and the Project Associate to ensure deliverables are provided in a timely manner.

Providing Updates to the Project Manager and the Country Leads with updates from the CSS team.

Coordination with Vendors for Translation, DCGI Submission, Photocopying and any other activities as required.

Processing and Tracking payments sent to sites for EC Submission.

Timely updating of CTRI website, responding to DCGI queries for Site Inspections.

Work with Australia and New Zealand teams for preparation of Country ICF’s for sponsor approval.

Documentation of each activity performed at workplace make the easy access of data to study team members.

Jul’10-Apr’12 with Covance India Pharmaceuticals Private Limited, Mumbai as Specialist I

(Global Site Services)

Job Role: Handled studies on Neurology and Respiratory for Site Start up and multiple indications for Feasibility.

First person to join the Department in India and responsible for setting up India specific processes, Train New Joiners and Monitors on the SSU processes and procedures.

Country Lead for India for Feasibility and Site start up activities for assigned studies. Responsible for the leadership and management of site start-up for an assigned group of studies.

Worked with major functional area leads (Project Management, Clinical Management, Clinical Administration, Legal, & Regulatory) to identify and evaluate fundamental issues pertaining to the successful site start-up of the projects, relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials.

With support from the Study leads, was accountable for ensuring that all project deliverables meet the customer’s expectations and the contracted deliverables, providing accurate projections, reports and updates, and on-going risk assessments, including accountability for delivery to time, cost and quality for assigned activities.

Primary contact with investigative sites during site start-up activities.

Responsible for working with investigative sites to collect the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor.

Responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.

Where applicable, provide logistical support for clinical trial supply coordination.

Liaise with operational project team regarding project issues. Page 6 of 8

Resolve informed consent and contractual language issues by exercising advanced judgment when interacting with study sites.Assess impact of changes in study amendments on Informed Consent and other study documents and revise and review/approve accordingly.

Negotiate contracts and budgets with investigative sites within parameters provided by the sponsor.

Liaise with Sponsor and Covance regulatory regarding document submission requirements. Significant Highlights:

Laid down working procedures specific for India.

Performed document collection from the site using eportal.

Maintaining payment tracker and preparing Budgets made the process of vendor payment easy.

Documentation of each activity performed at workplace for easy access of data to study team members.

Assisted in timely submission of CIOMs and safety reports to DCGI, tracking and maintaining original copies at study level.

Prepared a detailed database with site level details for study sites, which made job easier for all. Dec’06 to Jul’10 with Quintiles Research India Pvt Ltd., Mumbai as Senior Clinical Research Associate, Clinical Research Associate & Trainee Clinical Research Associate Job Role:

Performed Lead Activities and Project Management for an Ophthalmology and GI studies.

Managed clinical operational and quality aspects of allocated studies in compliance with ICH GCP and Schedule Y.

Develops Clinical tools e.g. Monitoring Plan, Monitoring Guidelines in conjunction with the Project Manager including Preparation of Study Logs and the Study Reference Binder, patient informed consent templates and other protocol specific documents as required.

In conjunction with the project manager prepared, organized and presented at Investigator Meetings.

In collaboration with the project manager, provide oversight of all study-related activities and monitoring of study conduct at assigned study sites.

Performed Selection, Monitoring and close out visits and Archival of the study documents.

Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.

Perform administrative duties including attendance at clinical monitoring staff meetings, project team meetings, clinical committees, clinical training sessions, etc.

Train new monitors on the site visits for start-up, monitoring and close out visits. On an average performed 8-10 site visit/ month and supported as SWAT CRA for Site Selection visits.

Served as the primary clinical operations contact for the Project Manager and CRAs.

Coordinated all start up activities and to ensure timely Ethics Committee and Regulatory submissions

(if appropriate) are addressed.

Provided input into the preparation of forecast estimates for clinical activities for resource management, assignment, the delegation of clinical responsibilities and identification of additional resource requirements.

Significant Highlights:

Managed Ophthalmology Project for India.

Planned Investigators meeting including arranging Venue, Agenda and Prepared study Presentations and Delivery. Appreciated by the Global project manager and Sponsor for smooth conduct of the Investigators meeting.

Sponsor and In-house Audit faced with no Critical Findings.

Participated in Training programs for SOP’s as part of Learning and Development.

Trained on Soft Skills, ICH- GCP, Schedule Y and India GCP. May’05 to Nov’ 06 with SRL Ranbaxy, Mumbai as Clinical Research Associate Job Role:

Page 7 of 8

Design and Preparation of Clinical Trial Presentation, Investigator Manual, Customized Test Requisition Form, Report Format and Patient ID Labels

Preparation of customized Lab standard reference ranges, specimen collection and study supplies for a clinical trial.

Participation in Investigator’s meetings

Daily interaction and co-ordination with investigations at site and the sponsor

Clinical trial management and customer service for investigator-sponsor queries and problems

Daily checking of clinical trial test requisition forms of specimens received from the site and providing the Reports for specimen received and reports generated / dispatched (Weekly / Monthly)

Maintenance of specimen storage records and providing it to the sponsors(weekly & Monthly basis)

Organizing specimen pick-ups from sites and international shipments to destinations abroad

Assisting customized reporting of test results to the Sponsor (e.g. MS-Excel format, Electronic Data Transfer).

Significant Highlights:

Prepared Study Specific Central lab reference Manual, Test Request Form- Visit wise.

Single handily managed a BA/ BE related trail and reporting with quick TAT.

Single handily planned, managed Sample collection kits for multiple sample collection throughout the day for a Global Project.

Jul’04 to May’05 with IPCA Labs, Mumbai as Officer Regulatory Affairs Job Role:

Preparing Dossiers, Packaging materials, pack-inserts for the approval of Drug Formulations to be marketed in Non-Regulated markets of Middle-East and Africa as per the country specific guidelines.

Responding to Queries raised by MOH from different countries of the Non-regulated markets with supporting documentation.

Prepared database of products under registration with Country- Specific requirements for ease of use to the team members.

Feb’03 to May’04 with Innovex India Pvt Ltd., Mumbai as Executive Scientific Information Job Role:

Identified, solicited and developed target market for promotion of sales to potential clients.

Maintained excellent business relationship with customer constant communication to develop rapport and

Strong pattern of customer loyalty, including major hospitals.

Assisted in the preparation and presentation of quarterly sales, market share, key accounts & operational and promotional budget analysis.

Monitored and obtained updates on stock inventory to ensure minimum stock levels for product availability at all times; provided inputs and recommendations about items to be re-ordered. Academia

Diploma in Marketing Management from Wellingkar’s Institute in 2004.

B.Pharmacy from V.M.H.P. Shah College of Pharmacy, Mumbai University in 2002.

One month In-plant training at German Remedies, Mumbai. Memberships

Pharmacy Council of India.

IT Skills

Proficient at MS Office (MS-Word, Excel & PowerPoint) Application. Page 8 of 8

Personal Dossier

Date of Birth : 26 Aug 1980

Permanent Address : 801/B, Vaishav Society, Bldg no 24, Shashtri Nagar Road No 1, Goregaon West, Mumbai- 400104, Maharashtra, India.

Languages Known : English, Hindi & Marathi

(Read and write)

I hereby solemnly, do affirm that the particulars furnished above are true to the best of my knowledge. Sapna Ghaitadkay (Khade)

Place: Mumbai

Contact this candidate