Sr. Clinical Trials Manager , Clinical Operations- Virology
United States – RemoteUnited 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. Gilead’s 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 company’s five core values. That’s 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 #CreatingPossibleFor Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.Job DescriptionCLINICAL 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.Specific Responsibilities and Skills for Position:
Experience and Skills:
- In partnership with Clinical Program Manager or Associate Director, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
- Communicates with functional peers regarding project status and issues and ensure project team goals are met
- Oversees operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out.
- Prepares and/or contributes to development of study-related documents (e.g., Clinical protocols, Informed consent forms, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report
- Coordinates data review to support interim/final data analysis
- Participates in study strategy development.
- Maintains study timelines.
- Contributes to development of study budget.
- Contributes to development of RFPs and participate in selection of CROs/vendors.
- Provide guidance and training to CROs, vendors such as IWRS, Central lab, eCOA, recruitment vendors, investigators and study coordinators on study requirements
- Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management).
- Proactively identifies potential study issues/risks and recommends/implements solutions.
- Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
- Participates in the recruiting and hiring process for CPA/CTMAs and supports their professional development
- May manage CPA/CTMA/Sr. CTMA and mentor other junior team members
- Coaches members of a work team and ensures adherence to established guidelines
- BS/BA degree in nursing, science or health related field with 6+ years of trial management experience - OR -
- MS/MA degree in nursing, science or health related field with 4+ years of trial management experience
For Colorado Job Applicants:
- Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
- Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management
- Highly developed leadership skills to successfully lead a clinical study team
- Ability to deal with time demands, incomplete information or unexpected events
- Must display strong analytical and problem solving skills
- Attention to detail
- Outstanding organizational skills with the ability to multi-task and prioritize
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
The salary range for this position is:
$124,240.00 - $186,360.00
Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.
Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing
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.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
For more information about equal employment opportunity protections, please view the 'EEO is the Law'
poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISION
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:
Please log onto your Internal Career Site
to apply for this job.