Clinical Data Manager - FSP

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, 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 activememberofamulti-disciplinaryteamtoplanand executetheDataManagementtasksrequiredfor 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

Knowledge and Experience: - 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. Education: - Bachelor’s Degree required (Master's Degree preferred) in the scientific/healthcare field. Apply directly on RemoteJobs.org: https://remotejobs.org/remote-jobs/clinical-data-manager-fsp-parexel