Staff Clinical Trial Leader
Johnson & Johnson
Diegem, Belgium
31 dagen geleden

OVERALL RESPONSIBILITIES : 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. POSITION DUTIES & RESPONSIBILITIES :

  • 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
  • People Leadership :

  • 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.
  • Business Leadership :

  • 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.
  • Functional and Technical Competencies :

  • 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
  • Leadership Competencies : Strong leadership required in alignment with J&J Leadership Imperatives :

  • Connect - Develop collaborative relationships with key internal and external stakeholders, across the global CoE as well as the resources providers and vendors to create a strong and productive partnership.
  • Shape - Make recommendations for, actively participate in and lead departmental process improvement activities.
  • Lead Take ownership for development of self and any allocated direct report and engage in transparent and constructive conversations.
  • Deliver - Strive to ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance to SOPs and regulations.
  • Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
  • Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
  • Performs other related duties as required.
  • Education

  • Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
  • Experience

  • BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred.
  • Previous experience in clinical trial management or equivalent is required.
  • Experience working well with cross-functional teams is required.
  • Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
  • Experience managing others, a plus.
  • Clinical / medical background a plus.
  • Medical device experience a plus.
  • What’s in it for you ? Caring for the world, one person at a time As an employee we consider you as our most valuable asset.

    We take your career seriously. As part of a global team in an innovative environment your development is key and our day-

    to-day responsibility.Through e-university, on the job training, various projects and programs, we ensure your personal growth.

    Our benefits make sure we care for you and your family now and in the future.

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