Clinical Trials Manager
- Employer
- Gilead Sciences, Inc.
- Location
- Foster City, California
- Salary
- See job description.
- Closing date
- Sep 27, 2021
View more
- Sector
- Pharmaceutical, Physicians/Nurses, Clinical Manager/ Director
- Hours
- Full Time
- Organization Type
- Corporate
- Jobseeker Type
- Professional
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Clinical Trials Manager
China - Beijing
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
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Management:
Mentors junior team members
Manages vendors
Task management may be required
May contribute to employee performance management
Project Involvement:
Manages geographical region(s) of a large complex clinical trial
Independently manages all components of a small less complex study
Has budget responsibility
Independently runs Phase 1 studies
Manages cross functional timelines
Applicable for biomarker operations
Collaborates with local medical affairs colleagues on country specific studies and initiatives
Provides knowledge and expertise on country specific regulations and site experience and suitability for development studies
Key Differentiating Contributions
Advanced project management skills adequate to manage the entire process of a clinical trial
Ability to identify issues and adapt to changes.
Ability to lead cross-functional teams internally and externally
Mentors team members
Ability to work independently with minimal oversight
Will incorporate study logistics and planning to accomplish study objectives
Job Responsibilities and Skills
Must meet all requirements for Sr. CTMA position and have demonstrated proficiency in all relevant areas
Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
Must be able to understand, interpret and explain protocol requirements to others
Maintains study timelines
Coordinates review of data listings and preparation of interim/final clinical study reports
Assists in determining the activities to support a project's priorities within functional area
Contributes to development of RFPs and participates in selection of CROs/vendors
May be asked to train CROs, vendors, investigators and study coordinators on study requirements
Contributes to development of study budget
May serve as a resource for others within the company for clinical trials management expertise
Able to examine functional issues from an organizational perspective
Participates in the recruiting and hiring process for CPAs and CTMAs and support their professional development
May contribute to development of abstracts, presentations and manuscripts
Under supervision, may design scientific communications within the company
Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
Must have a general, functional expertise to support SOP development and implementation
Excellent teamwork, communication, decision-making and organizational skills are required
Thorough knowledge of FDA and EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
Working knowledge and experience with Word, PowerPoint and Excel
Travel is required
Minimum Education and Experience
At least 5+ years of experience and a BS or BA in a relevant scientific discipline
1-4 SOP
Management:
Project Involvement:
Key Differentiating Contributions
Job Responsibilities and Skills
Minimum Education and Experience
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/China---Beijing/Clinical-Trials-Manager_R0021367
Copyright 2021 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency
jeid-3c1ae68104b14c4f86c97fb08a9f75b2
China - Beijing
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
['
Management:
Project Involvement:
Key Differentiating Contributions
Job Responsibilities and Skills
Minimum Education and Experience
1-4 SOP
Management:
Project Involvement:
Key Differentiating Contributions
Job Responsibilities and Skills
- CTMA
- /
- RFPCRO /
- CRO
- CPACTMA
- SOP
- FDAEMAICHGCP
- WordPowerPointExcel
Minimum Education and Experience
- 5BS BA
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
']
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/China---Beijing/Clinical-Trials-Manager_R0021367
Copyright 2021 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency
jeid-3c1ae68104b14c4f86c97fb08a9f75b2
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