Swapneel Waghmare
Chester,United Kingdom
Summary
- Results-driven Senior Business Analyst offering 10 plus years of experience in the clinical research domain. Adept at helping companies improve operational efficiency and team productivity. Hands-on leader with exceptional organisational, critical thinking and prioritisation skills.
- Expert in implementing risk-based monitoring (RBM) models to monitor trial processes affecting patient safety and data quality.
- Instrumental in gathering, verifying and finalising data to formulate reports and share results of findings with the project team and senior leadership,
- Articulate communicator with problem-solving, analytical, project management and team management skills
Overview
11
11
years of professional experience
4
4
years of post-secondary education
Work history
Senior business analyst
Infosys Technologies Ltd
04.2022 - Current
- Worked as a Business analyst for the Medical Affairs publication platform project in assisting with the Upgrade of the application from a desktop to a web-based platform
- Worked as an automation Business Analyst for Veeva eTMF migration and Veeva CTMS implementation as well as eTMF migration Proof of Concept (POC).
- Utilized defect tracking tool JIRA for reporting bugs/defects in functionality. Conducted weekly status meetings with development teams for defect resolution.
- Utilized Oracle SQL for querying database tables during testing.
- Delivered end-to-end IT systems and business change projects in line with project specifications.
- Involved in eliciting business requirements in detail.
- Analysed business processes, systems and data to identify opportunities for enhancement and efficiency.
- Collaborated with diverse teams to gather and document precise business requirements for alignment with organisational goals.
- Leveraged qualitative and quantitative analysis tools to assess data and report on findings.
- Reviewed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) test scripts.
- Coordinated with technical team and client for solution development
- Collaborated with cross-functional teams to implement operational improvements and business strategies.
- Maximised project ROI, performing user acceptance testing (UAT) to validate user requirements and expectations.
- Documented process flows and implemented requirements for functional improvements.
- Analysed complex data sets and studied impacts on business growth and operational efficiency.
- Applied strong analytical skills to translate business requirements into effective technical solutions.
- Uncovered root causes of complex business challenges and guided management with data-driven insights.
- Identified patterns and communicated findings to customers to integrate business requirements.
Centralized Monitor
IQVIA
03.2021 - 04.2022
- Managed the operational insight of the assigned project(s) and completed the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on the action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.)
- With guidance, provided Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation and workload projections.
- Supported Clinical Leads to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulations/guidelines and project Clinical Operations Plan.
- Performed centralized monitoring activities on assigned projects and evaluated the quality and integrity of the study as per the protocol, SOPs, respective regulations and guidelines.
- Performed Subject Level Data Reviews that required further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/Endpoints/SAEs etc.) and review any other information as necessary to determine overall readiness of the patient information for next level review.
- Maintained regulatory, ICH-GCP, and protocol compliance, providing actionable recommendations for site performance.
- Performed management of triggers and preparation of i-site pack for respective sites and countries for assigned studies.
- Escalated quality issues about the site and/or subject to respective stakeholders within the project team.
- Conducted periodic reviews of site-level KRls and historic site performance according to the Central Monitoring Plan.
- Monitored site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit)
- Supported the project management team to develop a monitoring strategy including monitoring triggers/thresholds.
eTMF specialist
IQVIA
06.2018 - 02.2021
- Supported the ISSC (Investigator strategy & site coordination) lead or representative to provide updates during weekly client teleconferences and internal team meetings, as required
- Participated in the drafting of the feasibility questionnaire for a study.
- Was involved in the ongoing submission of documents to the eTMF and review/Quality Control (QC) of the eTMF to ensure accuracy and completeness including working with sites, the Clinical trial manager (CTM), and the study team to resolve issues related to missing or expired documents.
- Created and maintained the eTMF Plan and TMF Index with the project manager/study lead and/or sponsors
- Assisted in the dissemination of confidential disclosure agreements (CDAs) and feasibility questionnaires to sites and followed up with sites accordingly to ascertain interest and meet study timelines
- Participated in the review and negotiation of the CDAs according to country-specific requirements
- Involved in sending regulatory packets to selected sites and documents/follows up with sites on the start-up process at the site
- Supports sites to answer any questions required for their local IRB/ethics committee submissions
- Depending on the country supported the review, negotiated Informed Consent Forms and followed up with sites and sponsors accordingly
- Performed site contact directly, or through a local representative (country dependent), as required to resolve issues before
- Worked on IRB/ethics committee submission and final review
- Collected and reviewed essential regulatory documents required to activate a site according to the study-specific regulatory management plan.
- Notifies the regulatory affairs department when initial essential documents are available for review
- Adhered to study timelines, documented/escalated study challenges and communicated updates to the Project Manager and Investigator strategy & site coordination (ISSC) Lead/Management.
Principal Project Assistant
PPD
04.2015 - 06.2018
- Oversaw procurement process for project supplies, minimising delays and cost overruns.
- Liaised with external vendors to secure necessary resources and services.
- Compiled and distributed project status reports for enhanced transparency and accountability.
- Collaborated with project teams in gathering user requirements and developing project plans.
- Liaised with monitors and investigative sites to resolve outstanding regulatory issues identified through ongoing regulatory review and investigator file reviews promptly.
- Developed and maintained assigned data points within the CTMS database according to the established conventions and tools for the project, within specified timelines.
- Facilitated cooperation between cross-functional teams regarding study activities.
- Performed file reviews and documented outstanding issues in project-related tracking tools i.e. CTMS
- Distributed the study Q&A / Directives log to the project team and/or notified the project team of where the updated version can be located.
- Led inspection/audit preparation activities and develop CAPA plans, as necessary, for related findings in conjunction with cross-functional leaders
- Performed the execution and dissemination of study-related information, including project tracking updates to clients, clinical study teams and other PPD departments.
- Upon direction of the Clinical Trial Manager/Project Manager to finalize the table of contents (TOC) for all study files (Central, Internal, Country, Investigator), develop and distribute filing guidelines to the clinical team.
- Assisted PM/CTM with the creation of study documents, checklists, and reports as needed.
- Assisted in the creation of study-specific documents and plans (e.g., Communication Plan, Project Plan, Monitoring Plan, etc.), study logs (e.g. Drug Accountability Log, Site Visit Log, etc.), study trackers (e.g. training tracker, FAQ, etc.)
- Facilitated communication between project team members and stakeholders.
- Assisted the Oversight Director at the Program level to coordinate/liaise with the functional leads and the study teams across thirteen protocols for study level updates which include a compilation of Program level Compliance metrics, Study team roster maintenance, Program level updates/reminders and disseminating appropriate study information to the applicable study teams.
- Reviewed and escalated appropriately site key risk/performance/quality indicators (KRI, KPI, KQI [e.g., early termination and screen‐fail rates, the average number of open findings, etc.]), ad‐hoc clinical listings review, tracking and trending of violations and deviations, ensuring visits occurred per the MP, site status, enrolment, CRF status and SAE follow‐up.
Records Management Associate
Syntel
03.2013 - 03.2015
- Involved in the processing of records, quality checks of processed clinical site and Clinical level records and indexing and filing of those records into the document management system
- Ensured that Records were processed and managed in compliance with GCP, 21CFR11 and mandatory standards of the Sponsor Company.
- Performed identification, processing and categorization of all the documents generated in Clinical Trials.
- Conducted quality checks of processed documents.
- Involved in updating MIS, QC report, Query log, and Attribute mapping of the document, data uploading in Documentum i.e., document repository of client database.
- Proofreading and final QC of the uploaded documents in the repository to deliver an error-free final product.
- Coordinating with the team for recent onsite updates and giving floor support to new joiners.
- Maintaining and reconciling Electronic Trial Master Files.
- Supporting clients in Regulatory, IRB/IEC submission, sponsor Audits and other applicable competent authorities Inspections.
- Implementing records Retention policy and Integrity of records in compliance with local and global regulations.
Education
Bachelor of Science - Biotechnology
Jawaharlal Nehru Engineering College
India 08.2008 - 07.2012
Skills
- Business Analysis
- Business Process
- Analytical Skills
- Requirements gathering
- Business requirements
- Software documentation
- Agile methodologies
- User Acceptance Testing
- JIRA
- SQL
- Communication
- Power BI
- Data Analytics
- Leadership
- Microsoft Excel
- Microsoft Office
- Clinical project management
- Agile/scrum projects
- Process improvements
Languages
English
Fluent
German
Beginner
Hindi
Fluent
Marathi
Native
Gujarati
Intermediate
Accomplishments
- Created requirements specifications, process flows and standardisation processes which decreased requirements gathering and analysis time by 50 %.
- Facilitated continuous interaction between users, development teams and stakeholders resulting in a 95 % success testing rate.
Certification
- Agile Requirements Foundations, issued Oct 2023, Issuing organisation-LinkedIn
- Business Analysis Foundations, issued Aug 2023, Issuing organisation-LinkedIn
- A Beginner's Guide to Writing User Stories issued Jul 2023, Issuing organisation-LinkedIn
- Creating Flowcharts for Beginners, issued Jul 2023. Issuing organisation-LinkedIn
- Scrum: The Basics, issued Jun 2023. Issuing organisation-LinkedIn
- Data Science & Analytics Career Paths & Certifications: First Steps, issued Jan 2022. Issuing organisation-LinkedIn
Volunteer experience
Volunteered as a sales assistant at SHARE NGO (Supporting Homeless Assisting Refugees Everywhere) based in Chester, UK from April 2023 to May 2023.
Work availability
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday
morning
afternoon
evening
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Quote
The man who views the world at 50 the same as he did at 20 has wasted 30 years of his life.
Muhammad Ali
Timeline
Senior business analyst
Infosys Technologies Ltd
04.2022 - Current
Centralized Monitor
IQVIA
03.2021 - 04.2022
eTMF specialist
IQVIA
06.2018 - 02.2021
Principal Project Assistant
PPD
04.2015 - 06.2018
Records Management Associate
Syntel
03.2013 - 03.2015
Bachelor of Science - Biotechnology
Jawaharlal Nehru Engineering College
08.2008 - 07.2012
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