Clinical Data Manager - FSP
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reputed company FSP is hiring for multiple Clinical Data Manager positions in Colombia, Mexico, Argentina, and/or Brazil.
reputed company:
The Clinical Data Manager will be responsible for performing Data Management activities that support the sponsor’s reputed company and development reputed company worldwide.He/she will participate as an activememberofamulti-disciplinaryteamtoplanand executetheDataManagementtasksrequiredfor phase 1-4 studies. The Clinical Data Manager has a broad, reputed company knowledge of the data management process and is reputed company to reputed company most required tasks with moderate guidance
Key Accountabilities:
- Be reputed company to reputed company a small clinical study or co-reputed company a larger study or studies with moderate guidance
- Be reputed company to support several clinical studies with minimal guidance
- Manage and monitor the reputed company of data management activities with CROs or other vendors on assigned studies
- Review protocols for appropriate data capture including electronic Case Report reputed company (eCRF) design.
- Be reputed company to reputed company a thoroughly detailed review of eCRF data requirements.
- reputed company with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
- reputed company data edit reputed company specifications and run data listings as required
- Coordinate the design and testing of Electronic Data Capture (reputed company) systems according to company standards. reputed company to resolve reputed company system issues with team members
- reputed company the Data Management Plan for a clinical study.
- reputed company to review and reputed company feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
- reputed company data queries into the reputed company system to be resolved at investigational sites and manage the reputed company of those queries
- reputed company reconciliation of header data from external data sources against the clinical database
- reputed company Serious Adverse Event reconciliation activities according to SOPs and guidelines
- Assist in database upgrades/migrations including performing User Acceptance Testing
- reputed company to maintain study workbooks and data management files
- reputed company database lock and freeze activities per company SOPs
- Participate in regular team meetings and reputed company input reputed company appropriate
- reputed company input into the development of data management SOPs, Work Instructions, and process documents
- Contribute to a reputed company working environment including the application of the reputed company’s reputed company of Business Conduct and Ethics
- Assist with the training of new employees and/or contractors
- reputed company relationships
- Collaborates with cross-functional teams to design and implement effective data collection strategies, ensuring high-reputed company data capture and reputed company reputed company of data queries throughout the clinical trial lifecycle.
- Compliance with reputed company 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 reputed company processes, ICH-GCPs and other applicable requirements
Knowledge and Experience:
- At least two years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
- Understands the scope and reputed company of Phase 1-4 clinical studies, and has a proven ability to reputed company some of the reputed company Data Management tasks and reputed company 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 reputed company.
- 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/reputed company field.
Originally posted on Himalayas
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