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Job Details

Senior Clinical Trials Manager

Company name
Exelixis, Inc.

Location
South San Francisco, CA

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Position Description

The Sr. Clinical Trials Manager is accountable for leading day-to-day management of operations of one to two Phase II/ Phase III 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.

Exelixis is currently located in South San Francisco and will move to Alameda around June 2018.

Position Requirements

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 from study start up to close out


  • 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/RN degree in related discipline and seven years of related experience; or,


  • MS/MA degree in related discipline and five years of related experience.


  • May require certification in assigned area.




Experience:



  • Typically requires a minimum of ten years of related experience in the clinical trials field and/or combination of experience and education/training.


  • Experience in Biotech/Pharmaceutical industry required.




Knowledge/Skills/Abilities:



  • Experience of managing the full cycle of a study from study start up to close out.


  • Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States


  • Experience in developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management


  • Experience in mentoring and developing junior staff


  • 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


  • 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




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.

Company info

Exelixis, Inc.
Website : http://www.exelixis.com/

Company Profile
Exelixis is a biopharmaceutical company committed to developing and commercializing small molecule therapies for the treatment of cancer. Our first commercial product, COMETRIQ™ (cabozantinib), is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer.

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