Global Trial Manager - Clinical Studies - Belgium

GLOBAL TRIAL MANAGER/DIEGEM, BELGIUM/6 MONTHS CONTRACT/76 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 (500k 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 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

EDUCATION & EXPERIENCE REQUIREMENTS:

- Masters or equivalent required. Preferably in Life Science, Nursing or Biological Science.
- Relevant experience or equivalent required.
- 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.

JOHNSON & JOHNSON IS AN AMERICAN MULTINATIONAL MEDICAL DEVICES, PHARMACEUTICAL AND CONSUMER PACKAGED GOODS MANUFACTURER FOUNDED IN 1886.

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