This job listing has expired and the position may no longer be open for hire.

Clinical Trials Manager at Exelixis, Inc.

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Alameda, California





Job Description:

Company Description

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.

As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.

Cancer is our cause. Make it yours, too.

Job Description

The Clinical Trials Manager is accountable for the day-to-day management of operations of one to two clinical trials, commensurate with complexity, including trial start-up, conduct, and close-out activities. This activity typically is coordinated in conjunction with one or more CROs.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Member of the Study Team (ST)
• May hold the role of ST Facilitator, and is responsible for the setting of agendas, effective facilitation of ST meetings, and the timely issuance and distribution of meeting minutes
• Facilitates all operational activities pertaining to the execution of clinical trials
• Serves as primary contact for Exelixis functional area representatives and vendors and is responsible for protocol execution
• Maintains regular internal contact with relevant departments such as Regulatory Affairs, Drug Safety, and others as necessary
• Responsible for the day-to-day interaction with CROs in the execution of ongoing clinical trials
• May assist with the development and review of study protocols, informed consent forms, case report forms, monitoring plans, study materials and monitoring tools
• Establishes study milestones and ensures accurate tracking and reporting of study metrics
• Assists with the resolution of questions about invoices to ensure accuracy and timeliness of vendor and site payments
• Reviews and tracks required documentation from clinical sites
• Reviews and resolves discrepancies in clinical data with CRO counterparts and clinical sites
• Reviews monitoring visit reports and ensures follow-up with CRO clinical trial manager(s) and/or escalation of issues as necessary
• Ensures that the site and subject status information in CTMS is updated and accurate; ensures timely updates to Clinical Operations line management and Senior Management
• Assists with ensuring regulatory compliance of clinical sites with company SOPs as well as GCP and ICH guidelines
• Provides input for the definition of new or revised process development, problem solving, training, etc, as needed
• May visit clinical sites (in conjunction with CRO, if applicable) for site evaluation, initiation, monitoring, or close-out activities.
• Travel within North America may be required up to 20%

SUPERVISORY RESPONSIBILITIES:
• NONE

EDUCATION/EXPERIENCE/SKILLS:

Education:
• BS/BA degree or MS/MA degree in related discipline or equivalent combination of education and experience.
• May require certification in assigned area.

Experience:
• Typically requires a minimum of six years of related experience in the clinical trials field and/or combination of experience and education/training.
• Experience in Biotech/Pharmaceutical industry preferred.

Knowledge/Skills/Abilities:
● Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States
● Solid clinical research knowledge and cross-functional understanding of clinical trial methodology
● Exhibits ability to learn and apply foreign regulations to the clinical trial/research process
● Willingness to gain experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
● Oncology therapeutic area knowledge essential
● Experience in monitoring and management of multiple sites as a Clinical Research Associate is preferred
● Ability to organize and prioritize several tasks and complete them under time constraints
● Applies strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques
● Resolves a wide range of issues in creative ways

JOB COMPLEXITY:
• Performs job duties with limited guidance from the Manager/Associate Director/Director, Clinical Operations
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions
• Networks with senior internal and external personnel in area of expertise

#LI-GA1

Additional Information

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.





More jobs in Alameda, California


Wind River Systems

Wind River Systems

ALAMEDA ALLIANCE FOR HEALTH
More jobs in General Business


The Kroger Co.

The Kroger Co.

The Kroger Co.