NEHA SHARMA

New Jersey, US

Mobile: +1-609-***-**** E-mail: adzuo7@r.postjobfree.com

LinkedIn URL: https://www.linkedin.com/in/neha-sharma-ns/ OBJECTIVE

Aspiring for the position of a Sr. Manager/Manager- Clinical Data Management, to contribute skills and expertise in the clinical data management of projects and clinical research studies . PROFILE SNAPSHOT

Experience: An enthusiastic, diligent, highly motivated and result driven professional with around 13+ years of overall experience including Clinical Data Management and Research Analysis (R&D) in Healthcare industry Knowledge & Expertise: Trained on ICH GCP, GCDMP and Six Sigma processes, with proven skills in Clinical Data Validation / Clinical Study / Project Management involving preparation of data management plans; monitoring/ supervising clinical data management team; providing key inputs to Clinical Trial teams to ensure consistency of analysis plans and eCRFs as per the Global standards. Clinical Data Management: Strong understanding of clinical research/data management, including creation of data specification documents/data-handling documents, coordinating with Clinical Research Associates (CRAs) / Contract Research Organizations (CROs), Data Management, Biostatistics, Medical monitoring, Medical writing teams, and key stakeholders for electronic Case Report Forms (eCRFs), Validation and Analysis Plans (VAPs), Data Handling Plans (DHP) and database design testing for assigned projects for project start up to the clinical study report and submission of abstract.

Technical Skills: Hands-on experience in the use of inform, Clintrial, Medidata Rave, Oracle Clinical, OC RDC, Microsoft Office (Word/Excel/PowerPoint) coupled with highly effective documentation and presentation skills essential to prepare Case Report Forms (CRFs), CRF Completion Guidelines (CCGs), Standard Operating Procedures (SOPs), Process Inputs (PIs) and train vendors / Data Management Associates on clinical data management activities.

FUNCTIONAL SKILL SET

• Clinical Data Management

• Clinical Research & Trials

• Protocol, Building Database for Study Start-up, Conduct & Close-out

• Design of Case Report Forms

• CRF Completion Guidelines & Data Management Documents for Clinical Trials as per ICH GCP Guidelines

• Knowledge in GCP standards, CDISC standards (CDASH, SDTM), FDA and ICH guidelines and recommended CDM best practices

CAREER CONTOUR

As Manager -Clinical Data Management

• Successfully spearheading a team of 15+ hardcore DM which include – SAS / Statistics / Medical writing team

• Responsible for planning, project management and task coordination services for biostatistics and data management functions.

• Established timelines for required deliverables and immediate milestones in all projects.

• Support Data Management vendor contracting, tracking of vendor work product and review invoices against expected work.

• Participate in program planning and management meetings.

• Diligently perceiving the performance evaluation of data management team in sync with technical performance

• Significant role contribution in project bidding; presenting the Data Management competencies to foreign clients; regulating the development of database model in accordance of CRF .

• Efficiently ascertaining the risk/maintaining the risk management plan for DM projects; assisting the programmers in database design and CRF annotations in compliance to SDTM standards ensuring tracking of all work in progress against milestones and escalate any delay, resource constraint or any risk anticipated. As Assistant Project Manager

• Played a pivotal role as a key point of contact (POC) for internal/external stakeholders for DM pertinent tasks for assigned projects/studies

• Proactively engaged in end-to-end undertakings encompassing – study startup/conduct/close-out activities with stringent adherence to stipulated timeframe, quality and costing

• Strategically responsible for safeguarding quality & compliance with standard operating procedures (SOPs)/ ICH-GCP for diversified allocated projects

• Actively provided assistance for external/certification audits and regulatory inspections

• Meticulously formulated/revised/evaluated/sanctioned project specific essential documents, plans deliverables and so on

• Involved in diversified plans which included - data management/data validation/quality management/ data review guidelines etc.

• Proficiently executed manual review of data listings; quality control (QC) checks/reviews and SAE reconciliations based on requirements

• Instrumental in generation/development of innovative & revised data management SOPs

• Efficiently executing trainings on database design and implementation to site users and pharmaceutical industry stakeholders

As Clinical Data Coordinator

• Key role involvement in vast gamut of tasks comprising of - guiding CDAs in User Acceptance Testing (UAT) leading to robust database design/procedure verification as a part of database validation

• Involved in an array of tasks such as – creating/processing/tracking of data clarification forms/updating clinical databases for safeguarding data validity; supported in database lock/freeze process and final data transfer activities

• Actively responsible for executing advanced QC functions; handling Project Management and creation & delivering training materials/on-the-job aids

Organization Designation Duration

Tech Observer, New Jersey Manager-CDM Aug 2017 – Sep 2023 Assistant Project Manager Mar 2015 – Aug 2017

Clinical Data Coordinator Mar 2013 - Mar 2015

• Strategically interfaced with specialty team members to assist set-up/management/conclusion of data management aspects of the project

PRECEDING ORGANIZATIONS

CLINICAL RESEARCH INVOLVEMENT-

Phase I-IV,PMS, RWE, and early Pk studies, involved in therapeutic areas such as Oncology, endocrinology, cardiovascular, ophthalmology, rare disease, device studies, respiratory, Liver diseases,MS, ALS etc EDUCATION

• PG Diploma in Clinical Research Data Management from ICRI, India, 2007

(Evaluated by WES as Canadian equivalent : Postgraduate diploma)

• Bachelor of Science (Microbiology) from HNB Garhwal University, India, 2006

(Evaluated by WES as Canadian equivalent: four years Bachelors’ degree) LANGUAGE SKILLS

• Proficient in English (having exposure to US cross-culture communication skills) TRAININGS / CERTIFICATIONS / CONFERENCES

• Training on Good Clinical Data Management Practices from Tech Observer

• Certified in Medidata Rave

• Certified in Oracle Clinical (version 5.1.0)

• Participated in SCDM Conference (2019 / 2016)

• Attended GCP/FDA audits

• Attended Investigator’s meetings at trial start up in US and Mexico regions Organization Designation Duration

Wincere Inc, India Senior Clinical Data Associate Feb 2012 - Aug 2012 Institute of Clinical Research, India Assistant Manager Nov 2011 - Feb 2012 Tata Consultancy Services, India Senior Process Associate Jul 2007 – Apr 2009

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