Clinical Data Manager III

1w1 week ago

Allucent

Chennai, IN · Full-time · INR 2,000,000 – INR 3,500,000

About this role

Allucent is dedicated to helping small-medium biopharmaceutical companies navigate complex clinical trials to deliver life-changing therapies globally. As Clinical Data Manager III, you manage and coordinate data management deliverables from database design and set-up through cleaning, reporting, and locking. This role ensures clinical data completeness, accuracy, consistency, quality standards, and regulatory requirements.

You lead as primary DM contact with internal teams like Clinical Programmers, Data Scientists, Project Management, Clinical Operations, Biostatistics, and external parties including sponsors, vendors, and sites. Plan and project resources, manage tasks, timelines, risks, quality, budgets, forecasts, and scope changes. Monitor progress and trigger necessary adjustments.

Develop, review, and maintain project-specific DM documents such as data management plans, eCRF specifications, data validation plans, and external data transfer agreements. Coordinate database set-up, eCRF design, validation, UAT, training materials, and project-specific training. Review study documents including protocols and statistical analysis plans.

Review and validate clinical data for consistency, accuracy, integrity, and completeness. Oversee data cleaning strategies, releases, transfers, reconciliations for SAE, PK, lab data. Manage database maintenance, lock, close-out, quality reviews, metrics, status updates, audits, and process improvements.

Join an A-team environment focused on pharmaceutical clinical trials. Propose and support efficiency initiatives, align data management and programming best practices. Participate in calls, meetings, problem-solving, and documentation for ongoing studies.

Requirements

Preferably Life science graduate or equivalent qualification
6+ years’ experience in clinical data management
Experience leading DM for clinical trials from design to lock
Proficiency in eCRF design, database set-up, UAT and validation
Knowledge of data cleaning strategies, review and reconciliation
Familiarity with DM documents like DMP, DVP, transfer agreements
Ability to manage resources, timelines, budgets and risks in DM projects

Responsibilities

Lead and serve as primary contact for DM with internal and external parties
Plan and project resources required including management of tasks, timelines, risk and quality
Monitor tasks against budget, forecasts, and trigger changes of scope requests
Develop, review and maintain project-specific DM documents including DMP, eCRF specifications, DVP
Lead and coordinate clinical study database set-up, eCRF design and database validation
Review and validate clinical data to ensure consistency, accuracy, integrity and completeness
Perform and/or coordinate data transfers and reconciliation activities including SAE, PK, laboratory data
Manage database maintenance, lock and close-out processes