Perform clinical data management for Phase I-IV studies: design and test eCRFs/EDC, develop edit checks and DMPs, manage queries, reconcile external data and SAEs, support database lock, and collaborate with cross-functional teams and vendors.
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel FSP is hiring for multiple Clinical Data Manager positions in Mexico, Argentina, Canada (all locations) and/or Brazil.Job Purpose:
The Clinical Data Manager will be responsible for performing Data Management activities that support the sponsor’s commercial and development projects worldwide. He/she will participate as an active member of a multi-disciplinary team to plan and execute the Data Management tasks required for phase 1-4 studies. The Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with moderate guidance
Key Accountabilities:
- Be able to lead a small clinical study or co-lead a larger study or studies with moderate guidance
- Be able to support several clinical studies with minimal guidance
- Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies
- Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
- Be able to perform a thoroughly detailed review of eCRF data requirements.
- Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
- Develop data edit check specifications and run data listings as required
- Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members
- Develop the Data Management Plan for a clinical study.
- Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
- Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries
- Perform reconciliation of header data from external data sources against the clinical database
- Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
- Assist in database upgrades/migrations including performing User Acceptance Testing
- Able to maintain study workbooks and data management files
- Perform database lock and freeze activities per company SOPs
- Participate in regular team meetings and provide input when appropriate
- Provide input into the development of data management SOPs, Work Instructions, and process documents
- Contribute to a professional working environment including the application of the client’s Code of Business Conduct and Ethics
- Assist with the training of new employees and/or contractors
- Collaborative relationships
- Collaborates with cross-functional teams to design and implement effective data collection strategies, ensuring high-quality data capture and timely resolution of data queries throughout the clinical trial lifecycle.
- Compliance with Parexel standards
- Complies with required training curriculum
- Completes timesheets accurately as required
- Submits expense reports as required
- Updates CV as required
- Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
- 5+ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
- Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform some of the core Data Management tasks and interact with vendors.
- Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
- Experience and understanding of the Oncology or CNS therapeutic area and with Phase III pivotal studies are desirable.
- Possesses strong English language written and verbal communication skills.
- Bachelor’s Degree required (Master's Degree preferred) in the scientific/healthcare field.
Similar Jobs
eCommerce • Edtech
Build and support scalable production web applications while improving engineering workflows, deployment processes, code reviews, and CI/CD practices. The role includes mentoring engineers, creating technical documentation and training, troubleshooting legacy and new codebases, evaluating tools, and collaborating with Brazil- and US-based teams. DevOps, SRE, platform engineering, Golang, and Ruby experience are advantageous.
Top Skills:
AWSContinuous DeliveryContinuous IntegrationDockerGoKubernetesRubyTerraform
Cloud • Computer Vision • Information Technology • Sales • Security • Cybersecurity
Provide technical support for CrowdStrike cloud services: troubleshoot, root-cause, resolve or escalate customer issues, document bugs, create KB content, and drive process improvements while maintaining strong customer communication and advocacy.
Top Skills:
AnsibleAvAWSAzureConfluenceDockerFirewallGCPHelmJIRAKernel-Level Security SolutionsKubernetesLinuxmacOSProxyRest ApiSalesforceSlackSplunkTerraformVpnWindowsWindows ServiceWindows Workstation
Cloud • Computer Vision • Information Technology • Sales • Security • Cybersecurity
As a Technical Account Manager, you will provide proactive technical support, onboard new customers, and ensure their success through engagement and training while collaborating with various internal teams.
Top Skills:
LinuxmacOSPythonRestapiWindows Server Operating Systems
What you need to know about the Toronto Tech Scene
Although home to some of the biggest names in tech, including Google, Microsoft and Amazon, Toronto has established itself as one of the largest startup ecosystems in the world. And with over 2,000 startups — more than 30 percent of the country's total startups — Toronto continues to attract new businesses. Be it helping entrepreneurs manage their finances, simplifying business operations by automating payroll or assisting pharmaceutical companies in launching new drugs, the city's tech scene is just getting started.
