Clinical Trials Manager- Virology
Clinical Trials Manager- Virology
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 OPERATIONS: Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products.
We are seeking a talented, experienced, and highly motivated candidate to join the Virology Clinical Operations team. This role is expected to be for management of Phase 2-3 clinical trials, including trials in specialized regions (such as Japan, China, and other parts of APAC) and/or trials in orphan disease (such as HDV) . As these trials are expected to support NDA or sNDA submissions, this role will likely include management of tasks supporting regulatory inspections in multiple regions.
Clinical Trials Manager, Clinical Operations - Virology (CTM)
Specific Responsibilities and Skills for Position:
- Drafts or reviews relevant documents including protocols, informed consents, case report forms, monitoring plans, other study plans, and clinical study reports
- Must be able to understand, interpret and explain protocol requirements to others
- Creates or maintains study timelines, including timelines for datasweep and CSR activities
- 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 a functional area
- Facilitate meetings, such as the cross-functional Study Management Team meetings or internal Clinical Operations team meetings
- 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
- Manage vendors, such as CRO, IXRS, and central laboratory vendors
- 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 and work collaboratively with cross-functional team members
- Participates in the recruiting and hiring process for Clinical Project Associates/Clinical Trial Management Associates/Sr. Clinical Trial Management Associates and support their professional development
- May participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
- Must have a general, functional expertise to support SOP development and implementation
- Travel may be required
- Excellent teamwork, communication, decision-making and organizational skills are required
- Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies. Knowledge of Japan GCP preferred.
- Working knowledge and experience with Word, PowerPoint and Excel. Experience with Microsoft Project preferred.
- Experience with CRO or vendor management
Experience and Skills:
- At least 5+ years of experience and a RN (2 or 3 year certificate) or BS/BA in a relevant scientific discipline
- At least 3+ years of experience and a Masters' degree or higher; scientific discipline preferred
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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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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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