Sr. Clinical Data Management Associate, Biomarker CDM Vendor Management

Sr. Clinical Data Management Associate, Biomarker CDM Vendor Management
United States - California - Foster CityUnited States – Remote

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

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.

Job Description
Sr. Clinical Data Management Associate, Biomarker CDM Vendor Management

Key Skills

• Works collaboratively within the Biomarker CDM Vendor Management team, which provides oversight to the transfer of data from contracted biomarker labs.
• Leads the design and implementation of the biomarker clinical data management processes with lab vendors including vendor assessment and data transfer development for sample tracking, sample processing, and assay data.
• Acts as consultant to study management teams with respect to biomarker data management risks and issue management.
• Serves as vendor escalation point of contact for issues including processes, query resolution, performance, etc.

Job Responsibilities

• Oversees contracted biomarker CDM resources managing the transfer of data from biomarker lab vendors to ensure tasks are performed according to Gilead's standards.
• Effectively interacts with vendors to communicate expectations for study timelines and milestones.
• Works collaboratively with Biomarker Sciences, Programming (Clinical and Statistical), Clinical Operations, Business Operations/Contracts and others such as Regulatory and Project Management staff to meet project deliverables and timelines for moderately complex clinical data acquisition, data quality review, and reporting.
• Provides technical and business process input/expertise on biomarker data management for clinical trial execution.
• General knowledge of FDA/EMA regulations and familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems, with sample management and assay data management databases a plus.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Demonstrates strong facilitation/presentation skills.

Requirements

• 5 years of experience and a BS degree.
• 3 years of experience and a MS degree.
• 2 years of experience and a PhD.

For Colorado Job Applicants: The salary range for this position is:
$100,000.00 - $150,000.00
Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.
Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing

For jobs in the United States:
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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

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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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