About the job
At Allucent™, we are passionate about empowering small to medium biopharmaceutical companies to navigate the complexities of clinical trials efficiently, bringing groundbreaking therapies to patients worldwide.
We are currently seeking a dedicated Senior Clinical Data Manager (CDM III) to join our exceptional team. In this role, you will oversee and coordinate data management deliverables from database design and setup through to data cleaning, reporting, and database locking, ensuring that the clinical data is complete, accurate, and consistent, meeting the highest quality standards and regulatory requirements.
Important: This position is not remote; candidates must be willing to work from our office in Chennai.
Your key responsibilities will include:
- Act as the primary contact for data management, liaising with internal teams (Clinical Programmers, Data Scientists, Project Management, Clinical Operations, and Biostatistics) and external stakeholders (sponsors, vendors, and investigational sites).
- Plan and manage resources, tasks, timelines, and quality assurance throughout the project lifecycle.
- Monitor project budgets, forecast timelines, and manage scope change requests as needed.
- Develop, review, and maintain project-specific data management documents, including data management plans (DMP), electronic case report form (eCRF) specifications, and data validation plans (DVP).
- Lead the setup and validation of clinical study databases, including eCRF design.
- Participate in the review of study documents (protocols, project plans, safety manuals, and statistical analysis plans) and coordinate the review of eCRFs.
- Oversee database User Acceptance Testing (UAT) and ensure all tasks are completed successfully.
- Prepare training materials for EDC users and deliver project-specific training as required.
- Review clinical data for consistency, accuracy, integrity, and completeness.
- Develop data cleaning strategies in collaboration with relevant functional groups and supervise data releases.
- Perform and coordinate data transfers and reconciliation activities for various data types (e.g., SAE, PK, external laboratory data).
- Create and assess project metric reports and provide status updates.
