Our Biotechnology client has an immediate need for a Clinical Data Manager to lead studies in the Sleep Medicine and Hematology/Oncology areas. You will be an active member of a multi-disciplinary team to plan and execute Data Management tasks required for phase 1-4 studies. In addition, you will be a part of an R&D Operations group that intends to implement the most up-to-date methods of data-driven trial management and hence has a key role in the organization.
- Able to lead a small clinical study or co-lead a larger study or studies with moderate guidance
- 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. 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 Code of Business Conduct and Ethics
Assist with the training of new employees and/or contractors
- BA/BS, preferably in the scientific/healthcare field.
- 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 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 solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.