Senior Clinical Data Manager – FSP

• Lead large clinical studies or related series of studies with minimal guidance
• Represent Data Management on the CTWG for assigned studies
• Mentor and train lower-level Data Management staff
• Manage and monitor Data Management activities with CROs and vendors
• Review protocols for appropriate data capture and eCRF design
• Review eCRF data requirements
• Collaborate with CRAs, programmers, study managers, and statisticians on eCRFs, annotated eCRFs, and CRF completion guidelines
• Lead development of data edit check specifications and data listings
• Coordinate design and testing of EDC systems and resolve system issues
• Develop or lead development of Data Management Plans
• Review and provide feedback on clinical team documents, including monitoring plans, statistical analysis plans, and vendor specifications
• Provide EDC and/or eCRF completion guidelines training
• Reconcile external header data and Serious Adverse Events against the clinical database
• Lead database upgrades and migrations, including User Acceptance Testing
• Maintain study workbooks and Data Management files
• Perform database lock and freeze activities according to SOPs
• Participate in team meetings and contribute to SOPs, work instructions, and process documents
• Assist with training new employees and contractors

• At least 8 years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
• Good project management skills and proven ability to multitask
• Understanding of Phase 1-4 clinical studies and ability to perform core Data Management tasks and interact with vendors
• Comprehensive understanding of regulatory guidelines and industry standards, including ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, and WHO Drug Dictionaries
• Attention to detail and ability to work individually, within a multidisciplinary team, and with external partners and vendors
• Strong English language written and verbal communication skills
• Experience and understanding of Oncology or CNS therapeutic area and Phase III pivotal studies preferred
• Ability to travel to off-site meetings or training seminars as needed
• Solid computer system and technical skills, ability to learn multiple computer applications, and experience with Data Management and Electronic Data Capture systems desirable
• BA/BS, preferably in the scientific/healthcare field

• Full-time employment
• Opportunity to contribute to therapies benefiting patients
• Training and mentoring opportunities
• Participation in a professional, multidisciplinary environment