Staff Clinical Trial Leader
Location:
Irvine , California
Posted:
January 05, 2017
Reference:
2342160810/1-en-us

Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Staff Clinical Project Leader (CRA), for Coherex to be located in either Diamond Bar, CA or Irvine, CA.

 

A recent acquisition within The CSS Group is Coherex Medical, a company focused on the development of a unique device for the treatment of patients diagnosed with atrial fibrillation and at risk for stroke. 


The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Sedation and Reprocessing all headquartered in our talent hub in Irvine, CA.

 

This individual will be responsible for leading one or several clinical trials within the Clinical R&D Operations CoE, as well as fostering strong, productive relationships with colleagues across the organization. Serves as the trial leader for clinical study execution. 

 

The Staff Clinical Project Leader will:

  • Serve as a Staff Clinical Trials Leader within the Clinical R&D Operations CoE operations group to execute company sponsored clinical trials for the Medical Device Franchises
  • Manage all operational activities of assigned clinical studies within the Clinical R&D Operations group
  • Serves as a member of the clinical trial/study/program core team and may serve as the liaison with the Clinical R&D Franchise and Clinical R&D BSDM for projects under his/her responsibility
  • May serve as the primary contact for clinical trial sites
  • Independently solves problems arising during clinical study execution, and will seek guidance for more complex problems, as needed
  • Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
  • May be involved in other tasks to support Clinical R&D Operations and R&D Clinical Franchise as needed
  • Plan, track, and manage assigned clinical trials/programs budgets to ensure adherence to business plans
  • Support the implementation of new clinical systems/processes, and provide support for publications, as needed.
  • Interface and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
  • Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
  • Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
  • Ensure that all Human Resource related activities, and decisions embody the Johnson & Johnson Credo Values.
  • Provide strong leadership within a clinical trial, ensuring that each team member has a well-defined set of activities and objectives specific to their role and responsibilities within the context of their business focus.
  • Ensure efficient use of resources within the clinical study/program to provide high quality deliverables.
  • Manage and mentor Clinical Trial Leaders/Senior Clinical Trial Leaders, as applicable.
  • Responsible for the training, performance management, and development of clinical staff, as applicable.
 
  • Accountable for quality, compliance with regulations and company procedures, resource requirement, timelines and budgets for assigned clinical projects, including those assigned to direct reports.
  • May lead clinical studies and/or programs that may involve multiple study managers/leaders and CROs (>300k USD annual investment).
  • Act as an operational expert rotating to new projects to provide technical expertise and training in starting new studies.
  • May support Senior CTM or CTM within a large or complex regulated clinical study/program.
  • Exhibit proficiency and act as a Subject Matter Expert in clinical trials involving complex design issues. May provide solutions and guidance on complex situations.
  • May manage work done by CROs under CTM/Senior CTM guidance.
  • Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, cost-effective, and high quality execution of assigned clinical studies/programs, including those assigned to direct reports.
  • Independent decisions for most situations, but may require guidance for to complex situations.  Minimal supervision needed.
  • Reviews and provides feedback on clinical operation section of protocols with minimal supervision.
  • Understand business value and balance overall business objectives and functional needs.
 

:

  • Requires knowledge of Good Clinical Practices
  • Knowledge and understanding of application of regulations and standards applied in clinical areas/regions.
  • Effective leadership skills in a professional and ethical manner
  • Strong Written and oral communication skills
  • Demonstrated competencies in the following areas are required:
  • Behave and lead in a professional and ethical manner
  • Presentation skills and influencing of others
  • Advanced technical writing skills
  • Advanced project management skills with ability to handle multiple projects 


Qualifications
  • A minimum of a Bachelor’s Degree is required, preferably in Life Science, Physical Science, Nursing, or Biological Science
  • MS or PhD is preferred
  • A BS with at least 6 years of experience, MS with at least 5 years of experience, or a PhD with at least 3 year of relevant experience is required
  • Previous experience in clinical trial management or equivalent is required
  • Experience working well with cross-functional teams is required
  • Relevant industry certifications are preferred (i.e., CCRA, RAC, CDE)
  • Experience managing others is preferred
  • Clinical/medical background is preferred
  • Medical device experience is preferred
  • This position may require up to 30% travel


Primary Location
United States-California-Irvine
Other Locations
North America-United States-California-Diamond Bar
Organization
Biosense Webster Inc. (6010)
Job Function
Clinical Trial Administration

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