Clinical Operations Project Management
Resume:
SAPNA RAHUL GHAITADKAY
(NEE: SAPNA KISHORE KHADE)
Contact: +91-982*******
E-Mail: **********@*****.***
Senior Managerial Assignment in
Clinical Research with a reputed organization in the CRO / Pharmaceutical industry Professional Summary
.
Pursed a Bachelor's in pharmacy followed by a Diploma in Marketing Management from Wellingkar’s Institute.
More than 15 years of work experience, of which more than 16 years in Clinical Research in varying roles within Clinical Operations, Project Management, and Clinical Operations Line Management.
Therapeutic experience in Gastroenterology, Oncology, Ophthalmology, Respiratory, Neurology, Dermatology/Immunology and Cardiometabolic 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, Bid defense, and Study Start-up to Study close-out activities including Project Management and Vendor Management. Experience Snapshot
Dec 2021- Ongoing with Parexel International India, as Clinical Operations Manager
Monitor performance by close interaction with project leadership/functional leadership and ensure that ongoing/revised project documentation and correspondence are accurate and complete.
Responsible for own assignments as a project team member. This may include taking the role of a senior-level contributor on a project team 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.
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.
Manage and oversee team activities including appropriate resourcing of staff, staff assignments, quality control, and efficiency of project deliverables.
Where assigned, produce accurate resourcing plans in conjunction with appropriate Project Team Members, including but not limited to facilitating appropriate resource identification and assignment, and monitoring resource needs throughout the project.
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.
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.
Central File documentation) and take appropriate remedial action.
Meet and aim to exceed client expectations by recruiting, retaining, and developing a skilled, experienced, and motivated team.
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. Page 2 of 8
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.
Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.
Where appropriate, may be tasked with support efforts for generating business leads (client networking, public speaking, etc.)
Where appropriate, may participate in and contribute to Project bids, including client presentations.
Where appropriate, may be responsible for coordinating client or account activities for department or function.
Where appropriate, take appropriate action following regular feedback sessions from the client’s technical groups.
Participate in and/or champion the implementation of PAREXEL and department system/standards improvement activities.
Maintain an agreed level of productivity/billability and staff turnover.
Complete routine administrative tasks on time (e.g. timesheets, training, travel expense claims). Travel as needed.
Maintain a positive, results-orientated work environment, building partnerships, and modeling teamwork, communicating to the team in an open, balanced, and objective manner.
Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, Parexel SOPs, and where applicable, sponsor SOPs.
May manage employees from multiple disciplines (e.g., in smaller countries) and act as role models for location. May serve as GMBA for a location or country.
Demonstrate leadership within a department, function, or location. This includes taking an active role in departmental, functional, or location activities (e.g., management meetings), ensuring employees adhere to corporate policies, and following up with management as appropriate.
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 is of the highest standards, errors are minimized, and 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:
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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.
Define and communicate job descriptions, core competencies, and performance standards and expectations.
Assist in the development and implementation of reward and recognition programs to achieve optimal employee satisfaction and retention.
Coordinate regular team meetings (at least with the frequency of two meetings per month) and ensure the 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, ensuring 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 the preparation and/ or review of project-specific plans and documents including Protocol, ICF (Global, Country, and Site), Study Logs and forms, and Newsletters.
Closely review and Track vendor KPIs, payments, and related documents.
Train Vendor CRA on in-house systems and processes.
Plan and Oversee the Investigator’s Meeting preparation and conduct including presentations.
Maintain FAQs 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. Page 4 of 8
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 CRAs for training, project related activities. etc.
Worked closely with the Central Monitoring Team, Data Management Team, and Drug supply team.
Involved in the weekly update calls with 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, and site information as appropriate (i.e., ClinAdmin); generate enrolment curves to support reporting. Prepare and present the 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 the Trial Manager in keeping an overview of drug availability at the site level in collaboration with country management and drug supply management.
Support Trial Managers in meeting set-up, minutes, running reports from systems, and 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 letters, visit report and follow-up letters.
Responsible for evaluation of country-level budget/ Grant Plan estimates and the negotiation of investigator's fees and country-related trial costs and monitoring the 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 FRMs.
Active involvement in the CSR- RAINBOW.
Member of the Diversity and Inclusion Team.
Part of the 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.
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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, Cardiovascular 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 the 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.
Demonstrated understanding of applicable ICH Guidelines, FDA Good Clinical Practices, PPD and client Standard Operating Procedures/Working Practice Documents/PWIs.
Conduct Feasibility within the allocated time.
Oversee site start-up for assigned projects according to timelines and quality standards.
Assists with coordination of the flow of information between PPD teams, clients, or functional departments involved in site start-up.
Develop 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 the 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/proactively.
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 on time.
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 the CTRI website, responding to DCGI queries for Site Inspections.
Work with Australia and New Zealand teams for preparation of Country ICFs for sponsor approval.
Documentation of each activity performed at the workplace makes 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, training 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, and regulatory) to identify and evaluate fundamental issues on 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.
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With support from the Study leads, was accountable for ensuring that all project deliverables met the customer’s expectations and the contracted deliverables, providing accurate projections, reports and updates, and ongoing 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 the operational project team regarding project issues.
Resolve informed consent and contractual language issues by exercising advanced judgment when interacting with study sites. Assess the 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 the Sponsor and Covance Regulatory Department regarding document submission requirements. Significant Highlights:
Laid down working procedures specific to India.
Performed document collection from the site using e-portal.
Maintaining a payment tracker and preparing Budgets made the process of vendor payment easy.
Documentation of each activity performed at the workplace for easy access of data to study team members.
Assisted in the timely submission of CIOMs and safety reports to DCGI, tracking and maintaining original copies at the study level.
Prepared a detailed database with site-level details for study sites, which made the 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 Ophthalmology and GI studies.
Managed clinical operational and quality aspects of allocated studies in compliance with ICH GCP and Schedule Y.
Develop 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 average performed 8-10 site visits/ month and supported as a 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 ensured 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 Investigator's meeting including arranging Venue, Agenda and Prepared study Presentations and Delivery. Appreciated by the Global project manager and Sponsor for the smooth conduct of the Investigator's meeting.
Sponsor and In-house Audit faced with no Critical Findings.
Participated in Training programs for SOPs as part of Learning and Development.
Trained on Soft Skills, ICH- GCP, Schedule Y and India GCP. Page 7 of 8
May’05 to Nov’ 06 with SRL Ranbaxy, Mumbai as Clinical Research Associate Job Role:
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 coordination with investigations at the 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 specimens received and reports generated/dispatched (Weekly / Monthly)
Maintenance of specimen storage records and providing them to the sponsors (weekly and 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 and test Request Form- Visit-wise.
Single-handily managed a BA/BE-related trial and reporting with quick TAT.
Single handily planned, and managed Sample collection kits for multiple sample collections 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, and pack inserts for the approval of Drug Formulations to be marketed in Non-Regulated markets of the 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 a 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 a target market for the promotion of sales to potential clients.
Maintained excellent business relationships with customers and 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, and operational and promotional budget analysis.
Monitored and obtained updates on stock inventory to always ensure minimum stock levels for product availability; 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
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Proficient at MS Office (MS-Word, Excel & PowerPoint) Application. Personal Dossier
Permanent Address : 801/B, Vaibhav Society, Bldg no 24, Shastri 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
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