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Clinical Trials Manager


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  • Beacon Hill Staffing Group - Pharma
  • 12/05/18
  • South San Francisco, CA
  • 94080
  • Contractor
The Clinical Trials Manager is accountable for the day-to-day management of operations of one to two (Clinical Trials Manager II: one to four) 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.
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
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
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


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