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Senior Clinical Data Management Associate

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Feb 2, 2024

View more

Discipline
Clinical, Clinical Data, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay, Best Places to Work

Job Details

Senior Clinical Data Management Associate
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.
Job Description



Senior Clinical Data Management Associate:

*This position is site-based

POSITION OVERVIEW:

Clinical Data Management (CDM) supports drug discovery, development and marketed products across Gilead by ensuring the accurate and timely acquisition, analysis and reporting of diverse clinical data through CRF / eCRF design, editing specifications and query resolution processes. CDM also manages data transfers from vendors, such as central labs and others.

You will act as the CDM lead on one or more clinical studies. You will lead the preparation of CRF/eCRF design. You will review study protocols and assist in the planning and implementation of CDM portions of clinical studies. You may act as lead in the oversight of vendors to ensure high quality processes for data review, data transfers and reporting. You will use standard / routine and non-routine reports to track study progress and ensure timelines and quality expectations are met. You will provide guidance and training to contract research organizations (CROs), vendors, investigators and study coordinators on CDM requirements. You will also support regulatory submissions of assigned projects.

Job Responsibilities:
  • Serves as lead for one or more studies or projects of increasing complexity, including participating in or leading cross-functional working groups.
  • Reviews study protocols and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet protocol requirements in a timely manner.
  • Identifies, tracks, and resolves CDM queries and issues.
  • Acts as a point of contact for study management teams and for Clinical Development regarding data management issues.
  • Works collaboratively with other colleagues to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.
  • Ensures completeness, accuracy and consistency of routine clinical data and data structure.
  • Ensures adherence to standard business processes within CDM systems to assure compliance with regulatory requirements.
  • May lead the design and implementation of the CDM process with vendors, including data entry, data quality checking, data transfer, reporting, backup and recovery.
  • Educates study teams and vendors on CDM processes and deliverables, including deviations from established processes.
  • Leads the preparation of CRF/eCRF design.
  • Utilizes reports to track study progress and ensures timeliness and quality expectations are met.
  • Provides technical and business process expertise on new and emerging technologies / vendors for clinical trial execution.
  • Leads or otherwise participates in the development, review and implementation of continuous improvements, processes, policies, SOPs and other guidance / process documents for CDM.
  • Trains and mentors less experienced in colleagues in CDM processes, projects, programs and tools.
  • Ensures assigned work complies with established practices, policies and processes and any regulatory or other requirements.


Knowledge & Other Requirements
  • Demonstrated proficiency in leading CDM or related deliverables, including understanding of project timelines and metrics to ensure databases are delivered as needed and in accordance with established timelines.
  • Demonstrates sound knowledge of FDA / EMA regulations, NDA and other regulatory requirements, and web-based EDC and CDM systems.
  • Demonstrated ability and effectiveness identifying, communicating and escalating project-level issues, such as processes, timelines, resourcing, performance, etc.
  • Demonstrates strong facilitation / presentation skills and ability to appropriately delegate tasks to others.
  • Demonstrated ability to be a fast learner.
  • Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
  • Strong communication and organizational skills.
  • When needed, ability to travel.


Minimum Education & Experience
  • PhD in life sciences or related discipline. PhD with relevant CDM or other data analytics / data management experience is preferred.
  • MA / MS in life sciences or related discipline with 3+ years' relevant CDM or other data analytics / data management experience.
  • BA / BS in life sciences or related discipline with 5+ years' relevant CDM or other data analytics / data management experience.
  • Multiple years' CDM or other data analytics / data management experience is preferred.


The salary range for this position is: $124,015.00 - $160,490.00. 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.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:


Please log onto your Internal Career Site to apply for this job.






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Company

Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

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