Clinical Data Manager - FSP

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.

Responsibilities

Lead a small clinical study or co-lead a larger study or studies with moderate guidance; 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; 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; Resolve EDC system issues with team members; Develop the Data Management Plan for a clinical study; 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; 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; Collaborate with cross-functional teams to design and implement effective data collection strategies; Comply with required training curriculum; Complete timesheets accurately as required; Submit expense reports as required; Update CV as required; Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements

Requirements

5+ years of experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment; Understanding of the scope and focus of Phase 1-4 clinical studies; Proven ability to perform core Data Management tasks and interact with vendors; 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; Strong English language written and verbal communication skills; Bachelor’s Degree in the scientific/healthcare field required

Nice to have

Oncology or CNS therapeutic area experience; Phase III pivotal studies experience; Master's Degree preferred