TRUSHALI ARUN MENDRE

New York, NY ***** • 347-***-**** • adlmfq@r.postjobfree.com

Professional Summary

Dynamic, organized and results-oriented with a record of developing projects from concept to execution in regulatory affairs industry with demonstrated impact and business benefit. Excels at partnering with all levels of the organization & stakeholders to create and implement a vision- driven project plan to meet business goals. Versatile and fiscally astute in tracking large project portfolios, clinical contracts, budgets, resources, and scope of work. Well versed with software like Microsoft Office suite, MS Project, Medidata, INFORM, RAVE, Jira, Citrix, eCRF, CTMS and IWRS

Skills

Cross-functional collaboration

Quality Management Systems

Regulatory submissions FDA and EU

Supervising resources

MS Office & MS Project

Stakeholder Management

Work History

Quality Management Intern, 04/2020 to 09/2020

VistaPath (Medical device start-up) – Boston, MA

Successfully managed and organized QMS implementation tasks, reducing time to implement supplier management and other key aspects of QMS implementation for Medical device start-up (Class I device)

Established and tracked quality department goals and objectives to implement quality control and quality assurance implementing ISO13485 and ISO9001

Collaborated with technical team for outstanding queries with Risk identification & analysis

Designed and developed Supplier Guideline, Voice of Customer analysis, as well as Audit plans for all suppliers (including contract manufacturer)

Implemented change orders as per scope changes.

Developed Microsoft Project Plan (Project management software) and requirements checklist for testing-subunit to the client

Associated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans

Disclosure Team Coordinator (Regulatory submissions), 04/2016 to 08/2018

Tata Consultancy Services – Mumbai, India

Coordinated with team for drug development Phase 1, 2a, 2b and Phase 3 Studies for therapeutic areas of Oncology, Dermatology, Hematology and Cardiovascular global studies and Biomarker analysis.

Assisted in Medical device submissions for Class I, II and III for PMA and 510k respectively and the required documentation (EU-MDR assistance)

Tracked the studies using Study logs, delegation logs, issue logs and other study trackers.

Collaborated with cross-functional teams and directed/ mentored the team members to get submissions done with quality and in time.

Anticipated associated project risks and issues and recommended solutions and strategies to meet the regulatory requirements to the client and or senior management

Directed teams on submission timelines and approval requirements.

Led the complex project for clinical trials as per ICH-GCP guidelines and successfully meet regulatory requirement by posting Protocol & Result summaries on Clinical trials.gov (CTg), using Protocol Registration System (PRS). The project was completed two-months ahead of the timeline

Reviewed the submission documents and ensured that they are in compliance with Regulatory requirements.

Responsible for stakeholder communications to construct, assess & communicate issues for clarification and resolution with US-FDA and EU regulations

Used advanced features of Microsoft Office (Word, Excel, PowerPoint, Sharepoint) to complete necessary reports for senior management review

Senior Regulatory Writer, 09/2015 to 04/2016

Tata Consultancy Services – Mumbai, India

Authored and reviewed more than 250 documents like Clinical disclosures (Result summaries and Protocol summaries) for Global Pharma clients & submitted to US FDA and EU. Authored and reviewed IND, NDA, Investigator’s Brochure(IB) and other Clinical trial documents.

Conducted quality checks for more than 250 disclosure documents for CTg and EudraCT posting, Protocol and Clinical study report (CSR), in timely manner, while adhering to the regulatory guidelines and the quality checklist

Planned and implemented training for team members for PRS entries on ClinicalTrials.gov and query resolution for errors generated in the system

Gathered the feedback and concerns put forth by the regulatory authority (specifically NIH and EU feedback on the drafts if any) and resolved them

Liaised between quality control and other departments and contractors, providing project updates and consultation.

Conducted data review and followed standard practices to find solutions.

DST Team Coordinator (Data Management), 08/2013 to 09/2015

Cognizant Technology Solutions – Mumbai, India

Built strong relationships with customers through positive attitude and attentive response.

Directed and coordinated the development of study modules on global studies to include checks and points as per amendments from Study team in the Case Report Form (CRF) & Data plans

Managed resources and mentored team-members for daily deliverables of study modules. Assisted and managed team workload to achieve specific targets

Leveraged project issues and resolution with the client and the Data standards support team for verification, testing and validation, given an outcome

Encouraged cross-functional collaborations with the client, statisticians, medical writers to ensure milestones achieved through time, with quality and budget

Worked on clinical projects in start-up, conduct, data freeze and database lock for Phase 1, 2 & Phase 3 studies.

Created query detail report, study status report, protocol deviation data listings, SAE and AE reports (with co-ordination with Safety team

Developed process improvements and offered actionable solutions to correct recurring issues

Narrative Writer, 04/2012 to 08/2013

Cognizant Technology Solutions – Mumbai, India

Authored & QCed Global Oncology phase 2 and 3 studies, for AELD's, Death, SAE, and AESI as per ICH-GCP guidelines for multi-country projects

Accomplished submission of 1200 narratives in batches, with apt use of Narrative tracking sheet.

Implemented use of ICH- GCP, GMP and ethical principles for clinical trials

Cross-functional communication to maintain quality in work

Authoring and QC of documents like the Clinical Study Report (CSR) and Protocol and resolved queries raised by regulatory authority

Site Feasibility Manager, 06/2011 to 03/2012

Meliorate Clinical Research Pvt Ltd – Pune, India

Independently strategized the overall business development and develop business proposals

Served as primary liaison between Investigators, CRO's and the project team for project initiation, negotiating Clinical trial agreements (CTA) or contracts and conduct of the trial

Reported senior management team to identify stakeholders for the project, budget and build the project plan. Define milestones, KPI, KRI, reporting & drive the project successful completion including stakeholder expectations

Steered meetings & follow-up with Doctors from various Therapeutic Areas for clinical trials

Coordinated independently with different vendors, CRO’s and Sponsor organizations for getting trials contracts for the Investigators and hospitals

Planned end-to end for every project deliverable managing the resources, the time and study logistics

Negotiated contracts and helped identify cost-saving suppliers and strategies

Presented the clients with Microsoft PowerPoint presentations as and when needed

Updated and reviewed all documents viz, Investigator Site File (ISF), Trial Master file (TMF), Protocol deviations, Memos & Subject files before monitoring visit. Tracked if every sites, IRB or EC submission of CIOMS, AE & SAE, Note to File, Protocol Deviation etc are in place

Reviewed the eCRFs with the source documents (Patient notes, IVRS records, lab records, IP logs) in databases like (INFORM, RAVE,) as respectively and see that all queries are resolved and Data clarification forms (DCFs) are resolved

Education

Master of Science: Project Management, Graduated 12/2020

Northeastern University - Boston, MA

Master of Science: Biotechnology, Graduated 04/2010

Pune University - India

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