Novotech, a leading global Clinical Research Organization (CRO), has announced a senior-level opening for a Principal Clinical Data Manager (PCDM) in Bangalore, India. This opportunity is ideal for experienced Clinical Data Management professionals seeking leadership roles in global clinical trials, data standards, and biometrics governance.
The Principal Clinical Data Manager job in India involves acting as a Subject Matter Expert (SME) across CDM processes, Electronic Data Capture (EDC) systems, CDISC standards (CDASH/SDTM), data visualization, and regulatory compliance. The role also includes client-facing responsibilities, team mentoring, and contribution to SOPs and organizational best practices.
This position offers strong career growth, exposure to global biotech clients, and the chance to work within Novotech’s highly collaborative and inclusive work culture.
Key Responsibilities – Principal Clinical Data Manager
Clinical Projects & Studies
- Serve as SME for Clinical Data Management (CDM) in client and internal project meetings
- Review and advise on clinical protocols, schedules of assessments, CRF alignment, and CDASH compliance
- Guide application of generic and disease-specific CRF libraries and CDISC standards
- Support CDM teams throughout the study lifecycle (startup to database lock and decommissioning)
- Review validation documentation for EDC, IWRS, ePRO, and other interfacing systems
- Oversee database design specifications, edit checks, data listings, dashboards, and reconciliation plans
Project & Financial Management
- Act as Project CDM / CDM Project Manager for assigned client accounts
- Develop and manage CDM project plans, timelines, and deliverables
- Handle budgeting, forecasting, invoicing, and change orders
- Maintain audit-ready TMF and CDM documentation
- Ensure compliance with SOPs, GCDMP, and regulatory requirements
Team Leadership & Training
- Mentor and train junior and senior CDM professionals
- Develop training materials and best-practice documentation
- Participate in industry forums, conferences, and audits
- Support internal compliance assessments
CDM Systems, Standards & SOPs
- Monitor advancements in EDC platforms and clinical trial technologies
- Lead development of CDISC-derived eCRF standards and libraries
- Drive process improvement initiatives and SOP updates
- Evaluate new tools and methodologies to improve CDM efficiency
Eligibility & Qualifications
- Graduate degree in Life Sciences / Clinical Sciences / Pharmacy / Biotechnology
- 8+ years of Clinical Data Management experience
- Minimum 4 years in a Senior CDM role within a CRO or pharmaceutical company
- Strong expertise in:
- EDC systems and clinical databases
- CDISC standards (CDASH, SDTM)
- Data reconciliation and inspection
- GCDMP, TMF, and EDC validation regulations
- Excellent stakeholder communication and leadership skills
Why Join Novotech? – Employee Benefits
- Flexible working options
- Paid parental leave (for both parents)
- Wellness and mental health programs
- Ongoing professional development and leadership training
- Inclusive workplace supporting diversity, equity, and belonging
- Global exposure across multiple therapeutic areas
Novotech is a Circle Back Initiative Employer and commits to responding to every applicant.
How to Apply
