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Local Trial Manager - Diegem, Belgium
Eingestellt von Elevate Direct
Gesuchte Skills: Support, Design
Projektbeschreibung
Local Trial Manager - Diegem, Belgium
This individual will be responsible for clinical trial management within the Clinical R&D Operations CoE, as well as fostering strong, productive relationships with colleagues across the organization. Serves as the liaison with the Clinical R&D Franchise for projects under his/her responsibility.
POSITION DUTIES & RESPONSIBILITIES:
Serve as a Clinical Trials Manager within the Clinical R&D Operations CoE group to execute company sponsored clinical trials for the Medical Device Franchises
Manage all operational activities of assigned clinical trials/programs within the Clinical R&D Operations group
Serves as a member of the clinical trial/study/program core team and may serve as the back-up liaison to the Clinical R&D Franchise and Clinical R&D BSDM for projects/trials/programs under his/her responsibility
May serve as the primary contact for clinical trial sites
Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed
Manage all operational activities of assigned clinical studies within the Clinical R&D Operations group
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 projects 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:
Provide primary 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 trial/program to provide high quality deliverables.
Manage and mentor Clinical Trial Leaders/Sr. Clinical Trial Leaders/Staff Clinical Trial Leaders, 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.
Act as an operational expert rotating to new projects to provide technical expertise and training in starting new studies.
May support Senior CTM within a large or complex regulated clinical trial/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 performed by CROs.
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.
May support clinical trial design and strategy.
Reviews and provides feedback on protocols.
Understand business value and balance overall business objectives and functional needs.
Non Technical Skills and Additional Details Functional and Technical Competencies:
Requires knowledge of Good Clinical Practices
Knowledge and application of regulations and standards applied in clinical areas/regions is required.
Strong project management skills with ability to handle multiple projects
Strong people management skills
Demonstrated competencies in the following areas are required:
Leadership in a professional and ethical manner
Presentation skills and influencing of others
Written and oral communication skills
Advanced technical writing skills
Advanced project management skills with ability to handle multiple projects
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.
EDUCATION & EXPERIENCE REQUIREMENTS:
Masters or equivalent required. Preferably in Life Science, Nursing or Biological Science.
Relevant experience
People management experience.
Significant previous experience in clinical project leadership across multiple studies/programs required.
Experience with budget planning, tracking and control required.
Relevant industry certifications preferred
Clinical/medical background a plus.
Additional information about the process
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
This individual will be responsible for clinical trial management within the Clinical R&D Operations CoE, as well as fostering strong, productive relationships with colleagues across the organization. Serves as the liaison with the Clinical R&D Franchise for projects under his/her responsibility.
POSITION DUTIES & RESPONSIBILITIES:
Serve as a Clinical Trials Manager within the Clinical R&D Operations CoE group to execute company sponsored clinical trials for the Medical Device Franchises
Manage all operational activities of assigned clinical trials/programs within the Clinical R&D Operations group
Serves as a member of the clinical trial/study/program core team and may serve as the back-up liaison to the Clinical R&D Franchise and Clinical R&D BSDM for projects/trials/programs under his/her responsibility
May serve as the primary contact for clinical trial sites
Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed
Manage all operational activities of assigned clinical studies within the Clinical R&D Operations group
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 projects 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:
Provide primary 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 trial/program to provide high quality deliverables.
Manage and mentor Clinical Trial Leaders/Sr. Clinical Trial Leaders/Staff Clinical Trial Leaders, 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.
Act as an operational expert rotating to new projects to provide technical expertise and training in starting new studies.
May support Senior CTM within a large or complex regulated clinical trial/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 performed by CROs.
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.
May support clinical trial design and strategy.
Reviews and provides feedback on protocols.
Understand business value and balance overall business objectives and functional needs.
Non Technical Skills and Additional Details Functional and Technical Competencies:
Requires knowledge of Good Clinical Practices
Knowledge and application of regulations and standards applied in clinical areas/regions is required.
Strong project management skills with ability to handle multiple projects
Strong people management skills
Demonstrated competencies in the following areas are required:
Leadership in a professional and ethical manner
Presentation skills and influencing of others
Written and oral communication skills
Advanced technical writing skills
Advanced project management skills with ability to handle multiple projects
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.
EDUCATION & EXPERIENCE REQUIREMENTS:
Masters or equivalent required. Preferably in Life Science, Nursing or Biological Science.
Relevant experience
People management experience.
Significant previous experience in clinical project leadership across multiple studies/programs required.
Experience with budget planning, tracking and control required.
Relevant industry certifications preferred
Clinical/medical background a plus.
Additional information about the process
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges