Job Description

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

We seek a highly motivated individual to join us as a Senior Manager, Clinical Data Management Standards (Metadata and Global Libraries Build) (CDMS). You will work with the Data Manager, EDC Programmer, Biostatistics, Programming, Clinical Scientist, Medical Monitors, and Clinical Operations teams in supporting our efforts in this exciting new area of Cell therapy. This role will be hands-on study support resource reporting to the Associate Director, Clinical Data Management or Director, Data management.

The Senior Manager, Clinical Data Management Standards, will provide leadership to achieve the strategic roadmap for industrialized standardization of historical clinical trial data using industry standards (e.g., CDASH, SDTM, ADaM) and related processes. Working collaboratively with internal and external organizational leads, you will provide high-quality, regulatory-compliant standardized data to improve clinical trials. The Senior Manager will support the development of technical expertise and documentation for data standardization activities and will help implement proprietary algorithmic data standardization models.

Responsibilities (include but are not limited to):

• Lead and provide oversight for the execution of the development and maintenance of global clinical data standards, including operational (eCRF and non-eCRF (e.g., lab, Imaging or ECG)) data mappings)
  • Utilize CDISC Study Data Tabulation Model (SDTM), controlled terminology, and other applicable industry standards in developing operational mappings.
• Mentor SME on operational data standards utilizing SDTM and/or Analysis Data Model (ADaM) standards, and Clinical Data Interchange Standards Consortium (CDISC) controlled terminology in the development of operational data standards
• Lead, facilitate and/or participate in the Standards Core Committee (SCC) committee
  • Review and finalize all the relevant materials to present it for SCC
  • Partner with functional area stewards
  • Organize standards topics to be reviewed and ensure decisions are made on time
  • Document meeting minutes and other actions and decisions
  • Provide input and information to facilitate discussion on critical decisions needed regarding standards use and implementation
• Support preparation and finalization of materials for the Standards Governance Committee (SGC) and address comments until all objects in scope are approved
  • Document meeting minutes and other actions and decisions
• Develop, maintain, and implement Global library standard objects (e.g., eCRF forms, edit checks)
  • Review and oversee the build, maintain, and document the Medidata Rave global library standard objects (e.g., eCRF forms, edit checks) to facilitate the creation of study-level databases
  • Work with Global Library Programmer (GLP) to implement new or modified global library objects (e.g., ensure GLP have clear understanding of what requires update).
  • Serves as a Global Librarian and gate keeper of the libraries (version controls)
  • Review the build and maintain CRF Completion Guidelines for all standard forms
  • Release the Global library package to internal and external stakeholders on time, within budget, and with high quality.
• Follow procedural documents and participate in reviewing and updating documents to ensure they reflect industry standards and are easily followed
• Manage data management standards timelines to ensure goals of teams are met
• Manage CDMS deliverables in coordination with internal and external cross functional teams
• Proactively identify risks and resolve issues impact standards (e.g., global library objects).
• Solution oriented to manage complex issues by escalating appropriately
• Oversee teamwork assignments and ensure timely delivery of global library objects.
• Communicate and reinforce content and interpretation of Kite data standards to project and study teams to ensure consistency in understanding and implementing standards across a project.
• Examine complex CDMS technical issues from various perspectives by utilizing appropriate CDMS concepts and resources
• Establish accountability, project level coordination and day to day oversight of Clinical Data Management Standards tasks
• Demonstrates an ability and desire to manage people, infrastructure projects, expert groups, and/or vendors
• Responsible for end-to-end clinical data management Standards activities and serves as a primary point of contact for internal and external study team members.
• Independently identify and propose process improvements while maintaining a strategic focus. Share new industry standards and best practices with project and study teams and departments as required
• Liaising with and reviewing work delivered by external partners (e.g., Function Service Providers, CROs, technology providers, etc.)
• Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.
• Lead complex initiatives to gather, organize, and analyze clinical data from various data sources and examines issues from various perspectives
• Lead in the developing Global Clinical Data Standards and other cross-functional SOPs, Working Procedures, Guidance documents, and job aids
• Lead and participate in identifying, reviewing, evaluating, and implementing new data standards-related technologies
• Develop training materials and provide training on CDMS and GLIB-developed processes
• Provide mentoring, coaching, and escalation support to more junior personnel or contract staff, as required
• Provide the relevant support and input to continuous improvement activities within Clinical Data Management Standards

Basic Qualifications

• PhD in life sciences or related discipline and experience in Clinical Data Standards – OR -
• MS/MA in life sciences or related discipline and 6+ years’ experience in Clinical Data Standards - OR -
• BS/BA in life science or related discipline and 8+ years’ experience in Clinical Data Standards – OR -
• High School degree and 12+ years’ experience in Clinical Data Standards

Preferred Qualifications:

• At least 8 years of relevant industry experience with clinical trials and a successful track record of leading through influence, working across complex, global organizational matrices.
• Experience in Industry Standards (e.g., CDISC) in either the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models.
• At least 10 years of clinical database developer experience or Data management experience in Rave with expertise in global library development and development of standard data collection objects.
• Excellent understanding of the drug development process with proven expertise in clinical trial execution and global library development/clinical database development in a global arena.
• Excellent knowledge of industry-leading EDC tools (e.g., Medidata Rave, Veeva EDC, Medrio EDC, Oracle, TrialGrid, etc.) and well versed in industry trends and emerging technologies supporting data collection.
• Understanding database and dictionary structures (e.g., MedDRA, WHODrug).
• Experience interpreting Health Authority regulations and GCP/ICH guidelines with a deep compliance background.
• Excellent working knowledge of the overall pharmaceutical development process.
• Excellent working knowledge of SDTM and creating data mapping specifications and annotated CRFs. Knowledge of requirements of define.xml.
• Experience in CRF design, query resolution, and general data validation.
• Technical expertise, technical writing ability, and proficiency in Systems Development Life Cycle (SDLC) principles.
• Excellent verbal and written communication skills, high ability to communicate standards-related issues, options, and their impact to project teams and within the department.
• Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory quality, etc.).
• Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.

The salary range for this position is: $136,000.00 - $176,000.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

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