Manager, Clinical Data Management
Manager, Clinical Data Management
United States - California - Foster CityUnited States - Washington - Seattle
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.
- Leads and provides oversight for the execution of data management activities at the project level (for a product or for multiple studies within an indication).
- May have accountability for delivery of departmental infrastructure projects.
- May be responsible for an expert group within the department (e.g. Laboratory Data, PK Data) and/or may have substantial responsibility for the management of outside vendors.
- Assists with data management activities for regulatory submissions.
- Participates in CDM organizational improvement discussions.
- Acts as consultant to study management teams with respect to data management risks and issue management.
- Understands the implications of conducting moderately complex studies outside of the United States.
- Coordinates and mentors CDMA I, CDMA II and Senior CDMA
- 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 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.
- Assist with response to questions and findings from Clinical Quality Assurance (CQA) and other audits at the study / vendor level.
- Communicates with functional peers regarding project status and issues and ensure project team goals are met.
- Participates in the recruiting and hiring process for CDMAs and support their professional development.
- Provides guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.
- Excellent verbal and written communication skills and interpersonal skills are required.
- Working knowledge and experience with FDA/EMA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA.
- Anticipates internal resource needs and external costs for the short and long term. Works with senior management and HR to ensure long-term resource allocation within a therapeutic area.
- Demonstrates the ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner.
Education and Experience
- 7 years of experience and a BS degree.
- 5 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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