Company: Elevate Direct Ltd
Location: Diegem, Belgium
Closing Date: 01 Mar 17
Salary (£): Competitive
R&D Global Trial Manager / Diegem, Belgium / 12 Months Contract / 68 to 87 EUR Per Hour
R&D Global Trial Manager / Diegem, Belgium / 12 Months Contract / Up To 87 EUR Per Hour
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
• 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.
• May lead clinical trials and/or a program that may involve multiple trial managers/leaders and CROs
• 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.
• 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.
• 8 -10 years of relevant experience or equivalent required.
• Minimum of 2 years people management.
• Significant previous experience in clinical project leadership across multiple studies/programs required.
• Experience with budget planning, tracking and control required.
• Relevant industry certifications preferred
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
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.
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