Principal Clinical Data Manager
- Canada
- Permanent
- Full-time
remote from anywhere in the U.S. or Canada
full-time, or Contract (candidate's preferance)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 departmentQualifications 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)
5-8 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 practicesPreferred Skills
Excellent organizational skills
Excellent communication skills, verbal and written
Exceptional attention to detail
Excellent interpersonal skills to drive and oversee a cross-functional team
Strong computer skills, including Microsoft Office and use of data management systems
Excellent problem-solving skills
Effective decision maker - able to exercise good judgment and take appropriate action independently
Flexible, team player
Proven ability to organize, delegate and effectively prioritize workload and deliverables