Principal Clinical Data Manager
hace 2 semanas
Remote from anywhere in Costa Rica
Contract
Job Overview
The Principal Clinical Data Manager is responsible for leading the clinical data management activities for a project including timelines, budget, client relationship and facilitation within the project team and cross-functional departments. Responsibilities include involvement and oversight of CRF design, database development, external data management, medical coding, data review, SAE reconciliation, discrepancy and query management and database finalization procedures in accordance with Atorus and/or sponsor standard operating procedures (SOPs), Good Clinical Practice (GCP), ICH Guidelines and sponsor requirements.
Job Responsibilities
- Serve as Data Management Lead on projects
- Serve as primary contact for Data Management with all relevant parties including but not limited to Clinical Operations and sponsor stakeholders
- Manage sponsor relationship and triage information and issues as appropriate
- Proactively coordinate and facilitate assignments of tasks and responsibilities to team members to support delivery of timely and high-quality results
- Provide training and guidance to less experienced Data Management team members
- Develop and implement project timelines
- Plan and execute multiple Data Management projects simultaneously
- Provide input, assistance and/or oversight with preparation of edit check specifications, case report form (CRF) design and specifications
- Assist and/or oversee the creation of test data for entry screens and edit checks
- Assist and/or oversee user acceptance testing (UAT) for assigned projects
- Create and maintain project specific Data Management Plan (DMP) and other relevant study documentation
- Provide study status tracking and metrics
- Review of data listings and reconciliation
- Discrepancy and query management
- Ongoing maintenance of electronic trial master file (eTMF)
- Perform study finalization activities
- Ensure team member performance supports project budget and delivery requirements
- Effectively manage project scope and ensure any changes to scope or out of scope are documented and approved per the change order management process
- Support and participate in the production of bid development and presentations
- Coordinate and participate in internal and external study team meetings, as required
- Active involvement in department meetings and initiatives
- Participate in and/or contribute to sponsor and/or regulatory audits and inspections
- Perform other duties as required by the department
Qualifications And Education Requirements
- University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
- 8 years data management experience working in pharmaceutical, biotechnology or Contract Research Organization (CRO) preferred
- Minimum 5 years of experience leading Data Management projects
- Global team experience required
- Additional relevant work experience will be considered in lieu of formal qualifications
- Broad knowledge of drug development processes
- Understanding of global clinical development budgets and relationship to productivity targets
- Knowledge of effective clinical data management practices
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