Gilead Sciences Inc

Senior Associate, Clinical Data Standards Management (CDSM)

Gilead Sciences Inc • $123K — $160K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Doctorate in Clinical Data Standards or EDC Programming experience
  • Master's degree with 3+ years in Clinical Data Standards or EDC Programming
  • Bachelor's degree with 5+ years in Clinical Data Standards or EDC Programming
  • Strong desire for Clinical Data Standards development and process improvement
  • Familiarity with regulatory requirements like FDA, EMA, ICH, and GCP

Responsibilities

  • Support development and maintenance of global clinical data standards
  • Apply CDISC standards in standards development
  • Develop and maintain global library objects like eCRFs
  • Assist in releasing the Global Library Volume (GLV) regularly
  • Contribute to developing CRF Completion Guidelines
  • Promote development and maintenance of GLV using multiple technologies
  • Support standards adoption by partnering with functional stakeholders

Benefits

  • Company-sponsored medical, dental, vision, and life insurance plans
  • Eligibility for discretionary annual bonus
  • Discretionary stock-based long-term incentives
  • Paid time off
  • Comprehensive benefits package for eligible employees
Full Job Description
Job Description

The Senior Associate, Clinical Data Standards Management (CDSM) supports the development, implementation, and maintenance of global clinical data standards across clinical programs. This role collaborates with Data Management, Clinical Programming, Biostatistics, and Clinical Operations to ensure consistent, high-quality, and regulatory-compliant standards implementation. The position is a hands-on contributor focused on global library development, governance support, and study-level integration. The Senior Associate, Clinical Data Standards Management reports to the Director of Clinical Data Management (CDSM) and works under the guidance of the Manager, Senior Manager and Associate Director to execute clinical data standards activities.

Responsibilities include, but are not limited to:

  • Support development and maintenance of global clinical data standards and operational data mappings
  • Apply CDISC standards (CDASH, SDTM controlled terminology) in standards development
  • Develop and maintain global library objects (eCRFs, edit checks, dynamics etc.)
  • Assist in regular releases of the Global Library Volume (GLV)
  • Contribute to CRF Completion Guidelines development
  • Work within multiple technologies to promote the development, maintenance and releases of the GLV (Medidata RAVE, TrialGrid, Azure, Smartsheet, SharePoint, Veeva Vault, etc.)
  • Support consistency and adherence to Kite standards across programs and portfolios
  • Support Standards Core Committee (SCC) and Standards Governance Committee (SGC) activities including preparation of materials, documentation of decisions and follow-up of action items
  • Partner with functional stakeholders to support standards adoption
  • Identify and suggest process improvements and support standards-related initiatives
  • Ensure compliance with regulatory requirements, industry standards, GCP/ICH guidelines and internal procedures
  • Provide study support during the initial EDC build on new studies including implementation of standards and facilitating Change Management, issue resolution, impact analysis, proposing solutions and escalation where appropriate.
  • Execute assigned global library build and maintenance activities
  • Perform quality checks to ensure standards implementation aligns with defined specifications
  • Document all standards release activities appropriately


Basic Requirements

  • Doctorate and Clinical Data Standards or EDC Programming experience
  • OR
  • Master's and 3+ years of Clinical Data Standards or EDC Programming experience
  • OR
  • Bachelor's and 5+ years of Clinical Data Standards or EDC Programming experience


Preferred Qualifications
  • Strong desire and passion to work in Clinical Data Standards development with demonstrated interest in process improvement and operational excellence
  • Working knowledge of CDISC standards (CDASH, SDTM, ADaM)
  • Experience programming in Medidata Rave EDC
  • Experience with at least some Medidata Rave modules including Rave Coder, Targeted SDV (TSDV), ePRO, Lab Admin, Rave Safety Gateway (RSG), Core Configuration and IRT Integrations
  • Experience in global library development
  • Understanding of clinical trial data collection and CRF design
  • Understanding of clinical data management processes including query management, site concerns, and data collection standards
  • Familiarity with FDA, EMA, ICH, and GCP requirements
  • Strong communication and cross-functional collaboration skills
  • Detail-oriented with ability to ensure consistency across studies
  • Working knowledge of regulatory requirements and industry guidance, including FDA, EMA, ICH and GCP


The salary range for this position is: $123,930.00 - $160,380.00. Kite 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.

About Gilead Sciences Inc

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, they seek to improve the care of patients suffering from life-threatening diseases. Gilead's primary areas of focus include HIV/AIDS, liver disease, and serious cardiovascular and respiratory conditions.

Gilead Sciences Inc Careers

Join the vibrant team at Gilead Sciences Inc, a leader in the biopharmaceutical industry known for its innovative approach to healthcare. At Gilead, we are committed to advancing the care of patients around the globe through rigorous science and research.

Work You’ll Do

Embark on a career journey with Gilead Sciences Inc, where job opportunities abound in a variety of fields, from scientific research to marketing and sales. Our team is dedicated to fostering an environment of diversity and inclusion, where every employee can thrive.

Innovate and Lead

At Gilead, innovation is at the core of everything we do. Join us and contribute to our mission of saving lives through advanced treatments and cutting-edge medicine. Our leadership is committed to nurturing professional growth, making Gilead an ideal place for those who aim to lead and innovate in the healthcare industry.

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Gilead Sciences Inc offers a wealth of career advancement opportunities. With personalized career development programs, employees are encouraged to pursue their professional interests and expand their skills. Whether through on-the-job learning, formal training, or leadership development, we provide the tools necessary for long-term career growth.

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Our team at Gilead Sciences Inc is composed of passionate, curious, and solution-driven professionals. By joining us, you’ll collaborate with some of the brightest minds in the industry. Our culture promotes teamwork and an interdisciplinary approach to problem-solving, making our workplace dynamic and innovative.

Internship and Employment Opportunities

Start your career with Gilead through our internship programs, which offer hands-on experience in biopharmaceutical development and business operations. For seasoned professionals, our employment opportunities span across various disciplines, inviting you to bring your valuable skills to our team.

Benefits and Culture

Gilead Sciences Inc is not only a great place to work but also offers competitive benefits designed to support the health, well-being, and financial security of our employees and their families. From health insurance to retirement plans and wellness programs, we ensure our team members are taken care of.

Networking and Professional Development

We emphasize the importance of networking and professional development within the company. Regular workshops, seminars, and training sessions are held to enhance your skills and knowledge. Additionally, Gilead’s strong emphasis on internal networking allows for cross-departmental collaboration and innovation.

Join Our Hiring Events

Stay connected with Gilead by joining our hiring events and exploring open positions that match your skills and interests. We are always on the lookout for dedicated, creative, and driven team players. Prepare your resume, ace the interview, and take the first step towards a fulfilling career at Gilead Sciences Inc.

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Keep informed with the latest company news, career tips, and industry insights—all from the people who work at Gilead Sciences Inc. Subscribe to our job alert emails and personalize your experience to receive updates that align with your career preferences. Join Gilead Sciences Inc today and be part of a team that values innovation, leadership, and a commitment to diversity and employee growth.
Learn more about Gilead Sciences Inc
Size
14,400 employees
Market Cap
$107.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$123 million
Founded
1987
5 Year Trend
-2.1%
Revenue
$24.6 billion
NASDAQ
GILD
* Ladders Estimates

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