Manager, Clinical Data Management
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. 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.
- Leads and provides oversight for the execution of data management process activities.
- Able to serve as lead on one or more complex initiative.
- May have accountability for delivery of departmental infrastructure projects.
- Able to effectively utilize change management strategies for process development and improvement across the department.
- This role serves as a transitional position for individuals on a management track or a technical track without direct reports.
- Individuals on a management track will be increasingly widening their interactions and impact upon the Clinical Data Science (CDS) department and other Development Operations functional areas, while gaining experience managing the progress and success of their direct reports.
- Supports 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.
- Provides data management process guidance to CDM staff.
- Collaborate with key stakeholders to assess process alignment/standardization within CDM and cross-functionally across the Gilead Development Operations organization, when applicable.
- Leads or supports projects and initiatives, and collaborates with subject matter experts and cross-functional stakeholders.
- Implements process changes through change management and communications.
- Advises on the development and delivery of internal training materials when needed.
- Supports remediation efforts and responses resulting from findings from clinical quality compliance and other audits.
- Performs evaluations of existing or prospective process/procedures and present findings clearly to senior leadership.
- Project manages multiple projects and continuously assesses prioritization.
- Works collaboratively with Programming (Clinical and Statistical) Clinical Operations, Biostatistics and others such as Clinical Research, GLPS, Regulatory and Project Management staff to meet project deliverables and timelines.
- Ensures completeness, accuracy and consistency of procedural documents, training and communication across all projects.
- Mentors CDM staff on business process.
- Leads and/or participates in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM.
- Leads and/or participates in CDM and cross functional initiative teams.
- Coordinates project level CDM tasks, while demonstrating knowledge of hands-on work.
- Communicates and escalates project level issues including processes, timelines, resourcing, performance, etc.
- Assists with response to questions and findings from Clinical Quality Assurance (CQA) and other audits at the study / vendor level.
- Participates in the recruiting and hiring process of CDM staffs to support business process development and their professional development.
- Working knowledge and experience with FDA/EMA regulations, GCP and familiarity with Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA.
- Demonstrates the ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner.
- Excellent verbal and written communication skills and interpersonal skills are required.
- Knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
- General functional expertise to support SOP development and implementation desirable.
- Experience within a pharmaceutical/biotechnology organization is preferred
- Clinical Data Management experience preferred.
- This role may require a few days of travel per year (when we return to office).
Education and Experience:
- 7 years of experience and a BS degree.
- 5 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 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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