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.