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Manager, Clinical Data Management

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Nov 29, 2022

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

Manager, Clinical Data Management
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.

Job Description


Manager, Clinical Data Management

Job Responsibilities:
  • Provides oversight for the execution of data management activities at the product or for multiple studies within an indication for biomarker CDM team.
  • Acts as consultant to study management teams with respect to data management risks and issue management.
  • Demonstrates an ability to prioritize and delegate effectively.
  • Demonstrates ability to assume expanded scope of responsibility with respect to volume and complexity of clinical project work.
  • Effective project management skills. Ensure the study are completed in a timely manner by the CRO.
  • Works collaboratively with Programming (Clinical and Statistical) Clinical Operations, Biostatistics and others such as Clinical Research, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for moderately complex clinical data acquisition, quality checking and reporting.
  • Ensures completeness, accuracy and consistency of clinical data and data structure across all projects.
  • Training and mentoring of CDM staff on business process and clinical programs.
  • Participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM.
  • Participate in CDM and cross functional initiative teams.
  • Project level coordination of CDM tasks, while demonstrating knowledge of hands-on work.
  • Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
  • Support of regulatory submission activities for assigned project.
  • Communicates with functional peers regarding project status and issues and ensure project team goals are met.
  • Provides guidance and training to CROs, vendors, on study requirements.
  • Excellent verbal and written communication skills and interpersonal skills and presentation skills are required.
  • Working knowledge and experience with FDA/EMA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems.
  • Demonstrates the ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner.
  • Reviews TMF for completeness.
  • Provide expertise on query resolution/data cleaning/data reconciliation to CRO staff when needed.


Education & Experience Requirements:
  • 6 years of experience and a BS degree.
  • 4 years of experience and a MS degree.

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.

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.
 

Find Us
Website
Location
333 Lakeside Drive
Foster City
California
94404
US
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