Clinical Data Manager III / Sr. Clinical Data Manager I – Bengaluru, India
Location: Bengaluru, Karnataka (On-site, Not Home-Based)
Department: Clinical Trial Organization (CTO)
Position Type: Full-Time
Experience Required: 7+ Years
Openings: 1
Job Overview:
Allucent is seeking a Clinical Data Manager III / Senior Clinical Data Manager I to lead end-to-end data management for global clinical trials. You will be responsible for overseeing database design, data validation, cleaning, external vendor coordination, and database lock procedures while ensuring the highest standards of compliance and quality. This is a pivotal, client-facing leadership role requiring strong technical, project management, and cross-functional collaboration skills.
Key Responsibilities:
Act as primary DM contact for internal teams and external clients/vendors.
Lead project planning and execution including resource estimation, timelines, risk mitigation, and quality tracking.
Oversee creation and maintenance of study-specific documents: DMP, DVP, eCRF specifications, data transfer agreements.
Coordinate with stakeholders for protocol review, database setup, validation requirements, and UAT completion.
Conduct EDC training for study teams and sites.
Monitor data consistency, quality, and completeness through effective cleaning strategies.
Perform reconciliation of external data sources (SAE, PK, Lab, etc.) and ensure compliance for data transfers.
Manage database lock, audits, filing, and quality review cycles.
Lead, train, and mentor junior DM staff; participate in interview processes.
Support proposal development, RFPs, and contribute to business development meetings.
Contribute to QMS process improvement, CDISC standards implementation, and internal SOPs.
Required Qualifications:
Bachelor's/Master's degree in Life Sciences or equivalent.
Minimum 7 years’ experience in clinical data management across various trial phases and therapeutic areas.
Proficiency with EDC systems (e.g., Medidata Rave), IRT, and eCOA.
In-depth knowledge of ICH-GCP, 21 CFR Part 11, GDPR/HIPAA.
Experience with CDISC standards (CDASH, TAUG) and their implementation.
Excellent project management, problem-solving, and communication skills.
Strong understanding of medical terminology and relational databases.
Proficiency in Microsoft Word, Excel, PowerPoint.
Preferred Skills:
Leadership experience in a fast-paced, client-facing CRO environment.
Strong documentation, organizational, and negotiation abilities.
Experience with internal and external audits.
Benefits:
Competitive salary and benefits package
Departmental training and upskilling budget
Spot Bonus and Loyalty Award programs
Flexible working hours (onsite position)
Internal career development pathways and mentoring
Access to global training platforms (e.g., GoodHabitz)
Employee referral bonuses
Estimated Salary: ₹14 – ₹18 LPA (depending on experience and expertise)
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