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Gilead Sciences
Gilead Sciences
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Gilead Sciences is a biopharmaceutical company developing and delivering medicines for life-threatening diseases. Its work has a strong focus on virology, including HIV and hepatitis, alongside growing research in oncology and inflammation. The company supports a global portfolio of more than 25 products and 50 clinical programs, while also investing in HIV research and health-equity initiatives. For job seekers, Gilead Sciences offers opportunities to contribute to research, development, and healthcare programs aimed at improving patient outcomes worldwide.
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Senior Clinical Data Management Associate (Remote, United States)

Lead clinical data management for Kite’s oncology development programs involving CAR T-cell therapies. Coordinate eCRFs, vendors, data quality, regulatory deliverables, and study timelines.

USUnited States
$115,260 – $149,160 / year
RemoteFull-timeSeniorEnglish RequiredData ManagementGeneral

Description

  • Oversee clinical data management studies from start-up through close-out for Kite’s clinical development programs
  • Partner with Biostatistics, Programming, Clinical Operations, Safety, and Regulatory teams
  • Report to the Senior Manager, Clinical Data Management
  • Coordinate deliverables and timelines for clinical data collection, quality checks, and reporting
  • Manage multiple studies with complex scope and volume
  • Lead studies and projects independently
  • Ensure clinical data and data structures are complete, accurate, and consistent
  • Lead eCRF preparation and design
  • Review protocols and lead or support planning and implementation of clinical data management activities
  • Work with site coordinators, investigators, and field clinical staff to collect data and resolve queries
  • Use reports to monitor study progress, timeliness, and quality
  • Prepare and maintain data management timelines
  • Provide CDM expertise for external vendor data coordination, collection, and cleaning
  • Manage CDM deliverables across internal and external cross-functional teams
  • Review clinical data continuously to support data quality
  • Support vendor implementation of data entry, quality checking, transfer, and reporting processes
  • 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 CDM systems follow standard business processes and applicable regulatory requirements
  • Participate in designing and implementing clinical data management processes
  • Serve as a contact for the study management team
  • Facilitate meetings and presentations
  • Delegate tasks to appropriate staff members
  • Identify, communicate, and escalate project issues involving processes, timelines, resources, and performance

Requirements

  • High school diploma with 9+ years of Data Management experience; BS/BA in life science or a related field with 5+ years; MS/MA in life sciences or a related field with 3+ years; or PhD in life sciences or a related field with 2+ years
  • Clinical data management experience in oncology, including knowledge of hematological cancers and cell therapy
  • Scientific background with experience handling laboratory data
  • Knowledge of FDA, EMA, and ICH clinical trial, statistics, and data management guidelines and regulations
  • Experience managing clinical data management deliverables for regulatory submissions
  • Strong problem-solving ability
  • Exceptional people and project leadership skills
  • Familiarity with industry thesauri and dictionaries such as MedDRA and WHODD
  • Proficiency with web-based electronic data capture platforms such as Medidata Rave and other clinical data management systems
  • Excellent verbal, written, and interpersonal communication skills
  • Ability to explain critical technical CDM concepts clearly to non-CDM staff
  • Ability to adapt to changing priorities, maintain attention to detail, work under pressure, and take on unfamiliar tasks
  • Experience facilitating meetings and presentations
  • Ability to delegate tasks appropriately to applicable staff members
  • Ability to identify, communicate, and escalate project-level issues
  • Must be eligible to work in the United States for this United States-based role

Benefits

  • Eligibility for a discretionary annual bonus
  • Potential eligibility for discretionary stock-based long-term incentives, depending on the 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 during the job application process

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