Senior Clinical Data Analyst – FSP

Role Overview

• Lead a large clinical study or a series of related studies with minimum guidance
• Represents Data Management on the CTWG for assigned studies
• Provide mentoring and training to lower-level Data Management staff assigned to your studies
• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts
• 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
• Lead the development of data edit check specifications and data listings
• 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 or lead the development of 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
• Provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed
• Perform reconciliation of header data from external data sources against the clinical database
• Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
• Lead 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; take a leadership role in the development of assigned documents
• Contribute to a professional working environment including the application of the sponsor’s Code of Business Conduct and Ethics
• Assist with the training of new employees and/or contractors

Requirements

• Bachelor’s Degree required, preferably in the scientific/healthcare field
• Proven leadership experience
• Good project management skills and a proven ability to multitask
• At least five years’ or preferably up to 8 years' experience, in Data Management for the pharmaceutical/biotechnology industry
• Understanding of the scope and focus of Phase I – IV clinical studies, and a proven ability to perform some of the core Data Management tasks and interact with vendors
• A high level of Phase I experience is essential
• A comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Strong English language written and verbal communication skills
• Able to travel to meetings or training seminars on occasion
• 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.

Benefits

• Annual performance-based bonus plan
• Annual salary review
• Total rewards incentives