Naziya Shaikh
Solapur
Summary
Results-driven clinical research and healthcare professional with over 16 years of experience, including 12+ years in Clinical Data Management and 3 years in Line Management. Currently serving as a Delivery Manager at ChampionX, with a distinguished track record at Syneos Health, IQVIA, Novartis, TCS, and Atos. Proven expertise in managing end-to-end data operations for global clinical trials, including leadership in a high-impact COVID-19 vaccine mega-trial. Recognized Subject Matter Expert for Safety Gateway.
Skilled across therapeutic areas such as Oncology, Vaccines, Respiratory, and Neuroscience. Proficient in industry-standard CDMS platforms like Medidata Rave, Veeva, and Inform. Adept at navigating regulatory frameworks and clinical trial workflows. Known for consistently achieving 100% CSAT scores, delivering strategic leadership, and driving successful project outcomes through meticulous planning and execution.
Certified in Scrum Fundamentals, with a keen interest in AI-enabled innovations in clinical data management and project delivery. Holds a valid USA business visa.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Delivery Manager
ChampionX
05.2024 - Current
- Led cross-functional teams in managing pharmaceutical and healthcare projects, ensuring alignment with clinical data management objectives and regulatory standards.
- Automated key processes within clinical data workflows, enhancing efficiency and ensuring compliance with GCP and FDA guidelines.
- Developed and maintained dashboards using Freshservice to monitor clinical trial data requests and ticket resolutions, facilitating real-time decision-making.
- Conducted comprehensive post-project evaluations, extracting lessons learned to inform best practices in clinical data management.
- Managed audit processes, serving as the primary liaison during internal and external audits, and ensuring readiness for inspections.
- Designed process flows with Microsoft Visio to streamline clinical data operations, reducing redundancies and improving data quality.
- Identified and implemented process improvements, optimizing workflows to enhance data accuracy and reduce cycle times in clinical trials.
- Assessed and mitigated project risks, ensuring clinical data activities met predefined objectives and timelines.
- Collaborated with global stakeholders, addressing organizational challenges to streamline clinical data project execution.
- Managed project resources effectively, recommending optimal team structures to support clinical data initiatives.
- Developed and enforced project management best practices, ensuring seamless planning, execution, and communication of clinical data projects.
- Mentored cross-functional teams in project management methodologies, fostering a culture of continuous learning within clinical data management.
- Provided training on project management frameworks, equipping team members with tools for effective clinical data execution and delivery.
- Championed change management initiatives, driving the adoption of new processes within clinical data management systems.
- Built and maintained strategic networks with internal and external stakeholders, integrating industry best practices into clinical data project execution.
Manager Data Management
Rite
11.2022 - 05.2024
- Led the production of clinical data management deliverables, including CRF/e-CRF, database setup, and validation
- Provided technical solutions to improve efficiency and support customers
- Ensured team compliance with SOPs, work instructions, and project scope
- Trained and mentored staff in data management processes
- Conducted bi-monthly meetings to review project status, risks, and resource utilization
- Developed strategies to enhance employee engagement and maintain consistency
- Worked with project leads on resource planning, workload forecasting, and staffing needs
- Acted as a backup for team members in case of absence or turnover.
- Supported internal and external audits, ensuring staff readiness and compliance.
- Created process maps for study start up, conduct and close out phases
- Kept higher management abreast of all the issues/challenges and suggested solution
- Served as primary point of contact for all CDM related queries
- Defined KPIs and processes and monitored them
- Involved in line management and conducted interviews for new candidates
- Handled project finance and forecasting
Project Data Manager
Syneos Health
09.2021 - 10.2022
- Acted as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups
- Coordinated the work of the assigned Data Management/Data Operations team
- Provided project specific training to internal and external teams as required
- Responsible for financial management of assigned projects / programs, including revenue recognition
- Prepared CRF specification document and identify unique CRFs & edit checks
- Prepared study related critical documents e.g. Trial Design Workbook, Data Transfer Agreement etc.
- Monitored and communicated project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management
- Planned, managed and requested resources for assigned projects
- Developed and maintained project plans, specifications and documentation in line with SOP requirements
- Maintained documentation on an ongoing basis and ensures that all TMF filing is complete and up to date
- Participated in, and presented at internal, Sponsor, third-party, and investigator meetings
- Planned for and created necessary documentation to support internal and external audits
- Trained and mentored data management staff
- Conducted interviews for CDM, PDM and freshers
Associate Data Team Lead
IQVIA
07.2018 - 08.2021
- Managed end-to-end delivery of data management services for single/multi-service projects including Covid-19 vaccine mega trial, ensuring quality deliverables on time and within budget
- Tested and implemented safety gateway
- Performed IWRS and tSDV set up testing
- Conducted CRA and Investigator training on safety gateway module
- Participated in the development and implementation of new technology or tools e.g. Safety gateway, DHD, SDTM feedback tracker, vTMF etc.
- Served as primary point of contact for customer on data management deliverables
- Created and updated Project Plan for the study setup, Data Cleaning during timelines/interim analysis and during the close out
- Provided justification for and performed direct negotiations with customer on timelines, finance & resources
- In study start-up phase, responsible for creating and updating critical documents like Major Protocol Deviation Criteria, SAE Reconciliation Guidelines, DM Quality Control Plan etc.
- Created local lab set up in UAT environment
- Reviewed and updated third party data handling guidelines and Data transfer agreements
- Managed SOW/budget of the trial
- Updated/submitted BUR and BWS for billing of monthly activities performed
- Carefully update EAC and track budget hours by pulling 1020 report on regular basis
- Identified out of scope tasks and track change orders to completion
- Served as Project Manager for single service DM projects, including financial tracking, revenue recognition and invoicing
- Trained and mentored junior DTL staff/new study member in DM expertise
Clinical Data Manager
Novartis
12.2016 - 07.2018
- As Clinical Data Manager (CDM) provided Data Management leadership across one or several trials. May have responsibility for a small program or indication within a large program
- Updated and managed the Data Handling Plan (DHP) and Data Review Plan (DRP) for assigned trials
- Performed SAE reconciliation using Safety database (ARGUS) and Clinical database and regular follow up with associates of Safety database, preparation of Safety Data Amendment Request Form (SDARFs), Maintaining SAE Tracking Sheet
- Performed critical activities as Imaging/Recist Reconciliation, PK Reconciliation, SAE Reconciliation
- Performed third party reconciliations such as ECG and Central Lab, IRT Reconciliations
- Performed Discrepancy management and Manual listings
- Provided study status in DRT (Data Review Team) and CTT (Clinical Trial Team) meetings
- Prepared high-level study metrics for multiple studies
- Updated DHP and performed User Acceptance Testing (UAT)
- Ensured consistency of assigned trials with program level standards (DHPs, DRPs and CCGs)
- Participated in the ongoing review of all data generated from the clinical study including central and local lab data
- Identified trends in the data and possible solutions for discrepancies
- Liaised with the sites & monitoring to ensure all eCRFs signed before DBL
- Maintained project documentation relevant to data management activities
- Assisted in preparing final study documentation
Senior Process Associate
Tata Consultancy Services
06.2015 - 11.2016
- As Clinical Data Manager (CDM) provided Data Management leadership across one or several trials. May have responsibility for a small program or indication within a large program
- Updated and managed the Data Handling Plan (DHP) and Data Review Plan (DRP) for assigned trials
- Performed SAE reconciliation using Safety database (ARGUS) and Clinical database and regular follow up with associates of Safety database, preparation of Safety Data Amendment Request Form (SDARFs), Maintaining SAE Tracking Sheet
- Performed critical activities as Imaging/Recist Reconciliation, PK Reconciliation, SAE Reconciliation
- Performed third party reconciliations such as ECG and Central Lab, IRT Reconciliations
- Performed Discrepancy management and Manual listings
- Provided study status in DRT (Data Review Team) and CTT (Clinical Trial Team) meetings
- Prepared high-level study metrics for multiple studies
- Updated DHP and performed User Acceptance Testing (UAT)
- Ensured consistency of assigned trials with program level standards (DHPs, DRPs and CCGs)
- Participated in the ongoing review of all data generated from the clinical study including central and local lab data
- Identified trends in the data and possible solutions for discrepancies
- Liaised with the sites & monitoring to ensure all eCRFs signed before DBL
- Maintained project documentation relevant to data management activities
- Assisted in preparing final study documentation
Clinical Data Analyst
Atos/Syntel
10.2012 - 04.2015
- As a backup study lead: planned, organized and executed the day to day activities of the project including managing the study team and liaisoning with clients & on-site personnel via phone and email support
- Reviewed and understood Study Protocol and Timelines
- Performed Query management\Discrepancy management
- Generated queries to clarify and improve the quality of the data
- Performed SAE reconciliation
- Performed Study Start-up activities (e.g. CRF Completion Instructions creation)
- Tested and executed validation procedures by performing User Acceptance Testing (UAT)
- Provided feedback to the clinical team on CRF
- Performed Freezing and locking activities
- Ensured activities are followed as per Timelines created and reporting to Study team in case of deviations observed
- Coordinated with Clinical Data Scientist and on-site personnel via Teleconference and Emails
- Perform Quality check on registration documents including published and source documents (e.g. Protocol, ICF, IB etc) using client standard checklist
Microbiologist
Dr.Aradhyeʼs Pathology Laboratory
11.2007 - 11.2011
- Conducted tests in specialized areas of hematology, microbiology and serology depending on departmental assignment
- Managed and Maintained clinical trial documents and patient lab reports
- Handled patient data and interacted with clinical trial patients/subjects
- Handled patient profiles
Education
Master of Science - Microbiology
Pune University
01-2007
Bachelor of Science - Microbiology
Shivaji University
01-2005
Skills
- Clinical Research
- Clinical Data Management
- Client and stakeholder management
- Stakeholder Management
- Project Management
- People Management
- Financial Management
- Process Management and Quality Control
- Data Validation and Operations
- Database Set-up, Cleaning and Locking
- Dataset Validation
- Training and Development
- Audit
- Change management
- Resource planning
- Risk assessment
Certification
Generative AI Overview for Project Managers 2025
Talking to AI: Prompt Engineering for Project Managers 2025
PMP Certification Training 2024
Scrum Fundamentals Certified 2024
PG Course in Clinical Research 2012
Notice Period
Less than a month (Negotiable)
Timeline
Delivery Manager
ChampionX
05.2024 - Current
Manager Data Management
Rite
11.2022 - 05.2024
Project Data Manager
Syneos Health
09.2021 - 10.2022
Associate Data Team Lead
IQVIA
07.2018 - 08.2021
Clinical Data Manager
Novartis
12.2016 - 07.2018
Senior Process Associate
Tata Consultancy Services
06.2015 - 11.2016
Clinical Data Analyst
Atos/Syntel
10.2012 - 04.2015
Microbiologist
Dr.Aradhyeʼs Pathology Laboratory
11.2007 - 11.2011
Master of Science - Microbiology
Pune University
Bachelor of Science - Microbiology
Shivaji University
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