Global Data Management
Company: IQVIA
Location: Bengaluru, India
Department: Global Clinical Data Management (CDM)
Job Type: Full-Time
Work Mode: Hybrid
JOB OVERVIEW
The Global Data Management professional is responsible for leading and overseeing Clinical Data Management (CDM) activities across global clinical trials, ensuring the delivery of high-quality, compliant, and timely clinical data. The role involves CRF/eCRF design, database development, data validation, study start-up support, project management, staff mentoring, proposal support, operational planning, and collaboration with cross-functional teams to ensure successful execution of clinical research projects.
KEY RESPONSIBILITIES
Clinical Data Management
Lead Clinical Data Management activities for global clinical trials.
Review and approve Clinical Data Management deliverables.
Oversee CRF and eCRF design and development.
Manage clinical database design and setup.
Ensure timely delivery of study databases and data management outputs.
Database Design & Validation
Design and review clinical databases.
Develop validation specifications and edit checks.
Support database programming activities.
Review database testing and validation results.
Ensure database quality and regulatory compliance.
Project Management
Support project planning and study start-up activities.
Monitor project timelines, budgets, and deliverables.
Identify project risks and implement mitigation plans.
Coordinate workload and resource allocation.
Ensure successful execution of assigned projects.
Leadership & Team Management
Mentor and coach Clinical Data Management staff.
Conduct regular performance and development meetings.
Identify training and professional development needs.
Ensure compliance with SOPs and corporate training requirements.
Promote employee engagement and continuous improvement.
Operational Excellence
Provide technical guidance to internal and external stakeholders.
Develop process improvements to enhance efficiency.
Support proposal development, RFIs, RFPs, and budgeting activities.
Participate in bid defenses and project kick-off meetings.
Contribute to operational planning and strategic initiatives.
Compliance & Quality Assurance
Ensure compliance with ICH-GCP, SOPs, and regulatory requirements.
Maintain inspection-ready documentation.
Support internal and external audits and inspections.
Ensure quality standards across all data management activities.
Monitor adherence to project scope and quality metrics.
Stakeholder Collaboration
Collaborate with Clinical Operations, Biostatistics, Programming, and Project Management teams.
Communicate project status, risks, and opportunities to leadership.
Support clients by providing technical solutions and guidance.
Coordinate with global teams to ensure consistent project execution.
Build strong relationships with sponsors and cross-functional stakeholders.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in:
Clinical Sciences
Biological Sciences
Life Sciences
Pharmacy
Biotechnology
Mathematics
Statistics
Or a related discipline
Equivalent education and relevant experience may also be considered.
EXPERIENCE REQUIREMENTS
Required
Experience in Clinical Data Management.
Experience managing global clinical studies.
Experience with Oncology therapeutic area.
Hands-on experience with Medidata Rave EDC.
Experience in database design, validation, and study setup.
Preferred
Experience leading Clinical Data Management teams.
Proposal, bid defense, and budgeting experience.
Experience supporting audits and regulatory inspections.
Knowledge of CDISC, SDTM, and clinical data standards.
Experience with global clinical trial operations.
Uttar Pradesh :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Basel | Zurich |Serbia :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
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Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Uxbridge | Renfrew | Mississauga | North York | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Tallinn |Hà Nội :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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