Clinical Trials Manager, Clinical Operations - Virology
Clinical Trials Manager, Clinical Operations - 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 Trials Manager, Clinical Operations - Virology (CTM):
Specific Responsibilities and Skills for Position:
- Must meet all requirements for Sr. Clinical Trials Management Associate position and have demonstrated proficiency in all relevant areas
- Serves as the key operational contact with external investigators and internal stakeholders, for successful implementation of Gilead (GS), Collaborative (CO), Investigator Sponsored Research (ISR) Studies, expanded access programs, and compassionate use programs
- Has ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility and fair market value assessment
- Establishes strong partnerships with external investigators and collaborators to ensure ongoing activities (e.g. sponsor updates, drug shipments, publications, milestone payments, etc) for CO and ISR studies are executed in a timely manner and with high quality
- Establishes strong cross-functional relationships and exhibits strong leadership skills with counterparts in other functional teams (e.g., CSM, CCF, DSPH, and Medical Affairs) to ensure efficient execution of the study management processes.
- Proactively identifies potential operational challenges and in collaboration with senior team members provides resolution plans to ensure study remains on track
- Implements and maintains working processes to promote high quality, efficient, and compliant systems and tools for CO and ISR study management
- Maintains a good understanding of industry standards and regulations for CO and ISR studies and keep abreast of any new changes and developments impacting Late Phase clinical operations.
- Organizes and leads clinical operational meetings
- Maintains internal Clinical Operations databases and document repositories
- For GS studies, drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, 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
- For GS studies, contributes to development of RFPs and participates in selection of CROs/vendors
- For GS studies, 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 CPA/CTMA/Sr. CTMA 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
- Travel may be required
- Collaborates with local medical affairs colleagues on country specific studies and initiatives
- Provides knowledge and expertise on country specific regulations, site experience, and suitability for development studies
- 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
- Working knowledge and experience with Word, PowerPoint and Excel
Experience and Skills:
- At least 5+ years of experience and a BS or BA in a relevant scientific discipline
- At least 5+ years of experience and an RN (2 or 3 year certificate)
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 firstname.lastname@example.org 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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