R and D Senior Local Trial Manager - Belgium 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 s
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POSITION DUTIES & RESPONSIBILITIES:
- Serve as a 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
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
- 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.
Work from home: 0 to 2 days per week
International Travel: Yes
No. of Positions: 1
Desired Skills & Experience
People Leadership: • 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. 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. • 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. EDUCATION & EXPERIENCE REQUIREMENTS: 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.