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description de la société
For a major player in the global pharmaceutical industry, we are looking for a senior local trial manager who will be responsible for clinical trial management within the Clinical R&D Operations CoE!
description de la fonction
Randstad’s mission is to shape the world of work by being a world leader in matching supply and demand in the labor market and in HR services. Randstad Professionals is part of the Randstad Group and creates opportunities for highly qualified and skilled professionals to work on successive projects on customers’ site.
Interested? Send your resume to firstname.lastname@example.org
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.
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:
Education: • Masters or equivalent required. Preferably in Life Science, Nursing or Biological Science.
Experience: • 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 • Clinical/medical background a plus.
You are flexible and you will receive a lot in return. You will get an attractive salary package with extra benefits: - group insurance, - hospitalization, - meal vouchers, - representation costs - training, ...