Senior Clinical Data Manager I (India)
Location: Chennai, Tamil Nadu (Hybrid – Not Home-Based)
Department: Clinical Trial Organization (CTO)
Position Type: Full-Time
Experience Required: 8+ Years
Openings: 1
Job Overview:
Allucent is seeking a Senior Clinical Data Manager I to lead and manage data management (DM) activities across clinical trials. This role involves overseeing database development, data cleaning, compliance, quality assurance, and locking processes while also mentoring junior team members and contributing to process improvements. As the primary DM contact for internal teams and external clients, you'll ensure that clinical data is accurate, regulatory-compliant, and delivered on time.
Key Responsibilities:
Lead data management activities from study start-up to close-out.
Act as the primary liaison for DM with internal stakeholders and external sponsors/vendors.
Plan resources, monitor budgets, and manage timelines and risk for DM deliverables.
Develop and maintain DM documentation: DMP, eCRF specs, DVP, data transfer agreements, etc.
Oversee and execute User Acceptance Testing (UAT) and ensure quality-controlled database setup.
Supervise data validation, consistency checks, and issue resolution throughout the study lifecycle.
Coordinate external data transfers and reconciliation (e.g., SAE, lab, PK).
Participate in contract negotiations and vendor management for EDC/IRT/eCOA systems.
Support audits, ensure audit readiness, and maintain proper DM documentation.
Train and mentor junior DM staff, contribute to SOP development, and support departmental learning.
Represent Allucent in professional forums, webinars, client meetings, and proposal discussions.
Required Qualifications:
Degree in Life Sciences, Healthcare, or equivalent education and experience.
Minimum 8 years’ experience as a Clinical Data Manager in pharma, CROs, or biotech industries.
Strong knowledge of ICH-GCP, 21 CFR Part 11, GDPR/HIPAA, and regional regulatory requirements.
Proven experience with EDC platforms and clinical study systems (IRT, eCOA, etc.).
Technical proficiency in relational databases, validation practices, and system testing.
Familiarity with CDISC standards: CDASH, TAUGs, and SDTM.
Effective in cross-functional leadership, stakeholder engagement, and client communication.
Exceptional written and spoken English communication skills.
Proficiency in Microsoft Office Suite and data management tools.
Preferred Traits:
Strong analytical, organizational, and negotiation skills.
Leadership mindset with a proactive approach to problem-solving.
Ability to simplify regulatory requirements into clear guidance.
Comfortable working in a fast-paced, growing global organization.
Benefits:
Competitive salary and performance-based variable pay
Health and retirement benefits
Departmental training and development budget
Flexible working hours with hybrid flexibility
Career growth, leadership, and mentoring programs
Access to e-learning via GoodHabitz and internal platforms
Spot Bonus and Loyalty Award programs
Internal mobility and promotion opportunities
Buddy program for onboarding and support
Estimated Salary: ₹18 – ₹25 LPA (based on experience and skillset)
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