Nawzar Shaikh

Experience

• 

  Prince Aly Khan Hospital - India

  Jul 2015 - Nov 2015

  Clinical Research Coordinator

  Learned and understood ICH-GCP(International Conference on Harmonization- Good Clinical Practice) and Schedule YLearned Investigational product management, data management, safety reporting, maintenance of regulatory and training documentationLearned about preparing and distributing documents to Ethics Committee members before IEC meetingsWrote down minutes of the meeting for the ethics committeeComply with terms, conditions and policies in day to day work of Clinical Research Coordinator Show less

• 

  NAROTAM SEKHSARIA FOUNDATION

  Nov 2015 - May 2016

  Clinical Data Coordinator

  Performed and/or supporting day-to day activities from study start-up to study close-outCommunicated with the subjects and taking their consent to participate in the study/ enrolling subjects Data collection, data verification and data entry in EDC systemScheduling follow up visits as per the protocolEnsuring protocol adherence and quality in trial conduct including risk mitigationCreated and implemented strategies to meet the study objective and timelineParticipated in trial monitoring visits and attending to any follow-up itemsAttended study scheduled meetings and provided input/ update on the study Study document archiving Show less

• 

  Tata Consultancy Services

  May 2016 - Jan 2019

  Process Associate- Clinical Data Manager

  Multitasking worked in EDC team, Data entry team and CDM.Provided leadership for Electronic Data Capture (EDC) team and main point of contact (POC) for the clientsCreated training materials, process improvement plans and work practice documents for internal and external teamPerformed data transfer and quality control Presented TCS in external meetings with clientsEffectively communicated with Study Data Managers, Clinical Operational Members and Database ownersPerformed task allocation and managed staffProvided feedback to team, train new team members and help grooming team membersPerformed Access management and Study Archiving for all GSK vaccine studiesUploaded documents in share point Effectively communicate with internal and external team membersPerformed Serious Adverse Event (SAE) management for interim and final study lockAwarder as start performer, completing task in before deadline with quality.was SPOC for safety first team and awarder as active Safety first spoc for Mahape Show less

• 

  Cognizant

  Jan 2019 - Aug 2021

  Clinical Data Manager

  Clinical Data Manager for Cardiovascular and Nephrology trials:Allocated task to team members for two phase III Nephrology protocols and one phase II Cardiology protocolPerformed User Acceptance Testing (UAT), third party data reconciliation, back end edit checks, manual review, query managementPrepared monthly study status reports Participated in Final study Database lockCoordinated with external team membersParticipated in sponsor audits, regulatory audit inspectionsExtracted and analyze clinical data per eCRF completion guideline to obtain data as per protocol, subject locking for interim and final DBL(Data Base Lock) Show less

• 

  Syneos Health

  Aug 2021 - Oct 2021

  Clinical Data Manager III

  Study Data Manager:•Reviewed protocol and provided input to the Lead study manager•Allocated and Reviewed study specific documents and provided input•Mentored and assisted junior data managers

• 

  Emmes

  Jan 2022 - Jan 2024

  Primary Clinical Data Manager

  Provided early strategic input into protocol design focused on data management issuesUtilized expertise in proprietary systems at Emmes (Advantage EDC, Advantage eClinical, Advantage Cloud) for efficient data management processesCollaborated in designing and developing study documents to ensure efficiency and data quality in clinical trialsMaintained accuracy on data quality, identifying and resolving discrepancies in a timely mannerCompleted all Data Management activities for four Protocols under the viral and infectious disease (VID) project and one Performed reconciliations (SAE, third party, lab) and review coding (SAE and CM)Designed and developed study-specific data collection forms and electronic data capture (EDC) systemsTrained clinical site staff on EDC systems and protocol collection data requirementsCompleted annual data audits for multiple protocol per adherence to SOP requirementsOperated knowledge transfer sessions, time management/SAS dataset/excel/tips and tricks within the project and other teamsReviewed and QCed Annual study report before submitting to regulatory bodiesCreated data quality audit report during initial enrollment at sitesWorked with the project delivery team to complete the project within the project timelineParticipated in training and mentoring new hires and colleagues on standards, process guidelines, and SOPs (Monitor and evaluate training performance)Operated knowledge transfer sessions, time management/SAS dataset/excel/tips and tricks within the project and other teams Show less