Gilead Sciences
Gilead Sciences
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.

Senior Clinical Data Management Associate at Gilead Sciences, United States Remote

Lead clinical data management for Kite’s CAR T-cell cancer therapy programs. Oversee eCRFs, vendors, data quality, study timelines, and regulatory deliverables.

Description

  • Manage clinical data management studies for Kite’s clinical development programs from start-up through close-out.
  • Partner with Biostatistics, Programming, Clinical Operations, Safety, and Regulatory teams.
  • Coordinate deliverables and timelines for clinical data collection, quality review, and reporting.
  • Manage multiple studies with complex scopes and high data volumes.
  • Lead studies and projects independently.
  • Maintain the completeness, accuracy, and consistency of clinical data and structures.
  • 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 reporting to monitor study progress and maintain timeliness and quality standards.
  • Develop and manage data management timelines.
  • Provide clinical data management expertise for external vendor data coordination, collection, and cleaning.
  • Manage CDM deliverables across internal and external cross-functional teams.
  • Conduct ongoing clinical data reviews.
  • Support vendor activities including data entry, quality checks, transfers, and reporting.
  • Create or support Data Transfer Plans and external data documentation.
  • Manage and coordinate external data deliverables.
  • Coordinate query management, report delivery, study timelines, and database snapshots for analyses, including Safety Review.
  • Ensure compliance with CDM business processes and applicable regulations.
  • Contribute to clinical data management process design and implementation.
  • Act as a point of 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, resourcing, and performance.

Requirements

  • High school diploma plus 9+ years of data management experience; or a BS/BA in life science or a related field plus 5+ years; or an MS/MA in life science or a related field plus 3+ years; or a PhD in life science or a related field plus 2+ years.
  • Clinical data management experience in oncology, with knowledge of hematological cancers and cell therapy.
  • Scientific training and experience handling laboratory data.
  • Working knowledge of FDA, EMA, and ICH guidelines and regulations for clinical trials, statistics, and data management.
  • Experience managing clinical data management deliverables for regulatory submissions.
  • Strong problem-solving ability.
  • Outstanding people and project leadership skills.
  • Familiarity with industry thesauri and dictionaries such as MedDRA and WHODD.
  • Proficiency with web-based electronic data capture platforms, including 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 colleagues.
  • Adaptability to shifting priorities, strong attention to detail, comfort under pressure, and willingness to handle unfamiliar tasks.
  • Experience facilitating meetings and delivering presentations.
  • Ability to delegate tasks appropriately to applicable staff members.
  • Ability to identify, communicate, and escalate project-level issues.

Benefits

  • Eligibility for a discretionary annual bonus.
  • Eligibility for discretionary stock-based long-term incentives.
  • Paid time off.
  • Company-sponsored medical insurance.
  • Company-sponsored dental insurance.
  • Company-sponsored vision insurance.
  • Company-sponsored life insurance.

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