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Senior Clinical Data Management Associate
Gilead Sciences. Oversee all aspects of clinical data management studies from start-up to close-out for Kite’s clinical development programs .
About the role
Key responsibilities & impact- Oversee all aspects of clinical data management studies from start-up to close-out for Kite’s clinical development programs
- Work closely with Biostatistics, Programming, Clinical Operations, Safety, and Regulatory teams
- Report to the Senior Manager, Clinical Data Management
- Collaborate to meet project deliverables and timelines for clinical data collection, quality checking, and reporting
- Handle multiple studies complex in scope and volume
- Lead studies and projects without supervision oversight
- Ensure completeness, accuracy, and consistency of clinical data and data structures
- Lead preparation and design of eCRFs
- Review study protocols and lead or assist in planning and implementing data management portions of clinical studies
- Interact with site coordinators, investigators, and field clinical staff to collect data and resolve queries
- Use reports to track study progress and ensure timeliness and quality expectations
- Prepare and manage data management timelines
- Provide CDM expertise for external vendor data coordination, collection, and cleaning
- Manage CDM deliverables with internal and external cross-functional teams
- Review clinical data on an ongoing basis to ensure quality
- Assist with vendor implementation of routine clinical data management processes, including data entry, data quality checking, data transfer, and reporting
- Create or support Data Transfer Plans and other external data documentation
- Manage and coordinate external data deliverables
- Coordinate query management, report delivery, study timelines, and database snapshots for analysis, including Safety Review
- Ensure adherence to standard business processes within CDM systems and compliance with regulatory bodies
- Participate in the design and implementation of clinical data management processes
- Serve as a point of contact for the study management team
- Facilitate meetings and presentations
- Delegate tasks to applicable staff members
- Identify, communicate, and escalate project-level issues involving processes, timelines, resourcing, and performance
Requirements
What you’ll need- High School diploma and 9+ years of experience in Data Management, or BS/BA in life science or related discipline and 5+ years of experience in Data Management, or MS/MA in life sciences or related discipline and 3+ years of experience in Data Management, or PhD in life sciences or related discipline and 2+ years of experience in Data Management
- CDM oncology experience and knowledge of hematological cancers / cell therapy
- Scientific background and experience with lab data handling
- Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management
- Experience managing clinical data management deliverables for regulatory submission
- Ability to problem solve
- Exceptional people/project leadership skills
- Familiarity with industry-wide thesauri/dictionaries such as MedDRA and WHODD
- Proficiency in web-based Electronic Data Capture, such as Medidata Rave and other clinical data management systems
- Excellent verbal and written communication and interpersonal skills
- Ability to clearly describe critical technical CDM aspects to non-CDM staff
- Ability to work flexibly with changing priorities, remain detail-oriented, work well under pressure, and take on unfamiliar tasks
- Demonstrated meeting facilitation/presentation skills
- Demonstrated ability to appropriately delegate tasks to applicable staff members
- Demonstrated ability to identify, communicate, and escalate project-level issues
- Must be eligible to work in the United States as this is a United States-based role
Benefits
Comp & perks- Discretionary annual bonus eligibility
- Discretionary stock-based long-term incentives eligibility may vary based on role
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance
- Inclusive work environment
- Reasonable accommodation in the job application process