13 Aug
|
Allucent
|
Chennai
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
📌 Clinical Data Manager III (Chennai)
🏢 Allucent
📍 Chennai