Clinical Data Manager III (India)

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for Clinical Data Manager III (CDM III) to join our A-team. As CDM III at Allucent, you will manage and coordinate DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.   

PLEASE NOTE: This is not a remote position and we are looking for a candidate who can work from the office (Chennai Location).

In this role your key tasks will include: • Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites)     • Plan and project the resources required including management of tasks, timelines, risk and quality    • Monitor tasks against and keep track on budget, forecasts, identify and trigger changes of scope requests   • Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements    • Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements    • Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs)    • Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks    • Create training materials for EDC users and provide project-specific training as required   • Review and validate clinical data to ensure consistency, accuracy, integrity and completeness   • Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)  • Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data   • Create and review project metric reports, status updates, study progress to Lead DM in order to share information on site performance issues, data trends and protocol non-compliance  • Support and conduct Quality Review checks during study. As lead DM, may organize and lead Quality Review activities   • Assist in contracts negotiation and contracting process with vendors (EDC, IRT, eCOA)  • Manage the database maintenance, lock and close-out processes and procedure  • Participate in conference calls and/or meetings with vendors and sponsors  • Recognize and solve potential problems and evaluate effectiveness  • Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date    • Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned  • Help to align data management and clinical programming best practices, standards and conventions within the company  • Propose and support initiatives for improving efficiency.