Clin Data Mgmt Assoc II
Clin Data Mgmt Assoc II
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. Gileads 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 companys five core values. Thats 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
Clinical data managers work collaboratively with internal and external colleagues and vendors to support Gilead's business objectives by ensuring the accurate and timely acquisition of diverse clinical data through efficient CRF/eCRF design, edit specifications, and query resolution processes.
- May lead a study or group of related small studies.
- Demonstrates the ability to lead a study (ies)/project(s) with minimal supervision.
- Serves as a point of contact for study management team.
- Effectively interact with cross-functional team
- Assists in implementing routine activities involving CDM interaction with other study management team members.
- Reviews study protocols and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner.
- Identifies, tracks, and resolves routine queries and issues.
- The point of contact for Clinical Research regarding data management issues.
- Demonstrates ability to identify problems early and communicate escalation issues appropriately.
- Works collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and others such as Clinical Research, Global Patient Safety, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.
- Demonstrates a general understanding of each assigned protocol, critical tasks and milestones.
- Ensure completeness, accuracy and consistency of routine clinical data and data structure.
- Assists in the implementation of routine clinical data management process with vendors including data entry, data quality checking, data transfer and reporting.
- May lead in the preparation of CRF/eCRF design.
- Reviews study protocol and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner. Identifies, tracks, and resolves routine queries.
- Utilizes routine reports to track study progress and ensures timeliness and quality expectations are met.
- Excellent verbal and written communication skills and interpersonal skills are required.
- The ability to problem solve and have people/project leadership skills.
- Knowledge of FDA/EMA regulations, support of needs for NDA and other regulatory submissions, and familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems.
- Demonstrates understanding of project timelines and metrics to ensure databases are delivered to set timelines.
Education and experience
- 4 years of experience and a BS degree.
- 2 years of experience and a MS degree
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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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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:
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