Provide leadership and expert oversight of clinical studies including project planning, budget, resource management and contract research organization negotiation and management
Contributes to clinical development plans and ensures alignment to business and regulatory strategies
Act as a cross-functional liaison between clinical operations and product development teams and ensures effective alignment regarding plans, requirements, and deliverables
Manages all aspects of study progress from start-up to close-out activities adhering to intended timelines to achieve study goals while ensuring compliance with ICH/GCP, MDR and ISO-14155 guidelines, regulatory requirements, and SOPs
Oversees and manages CROs, vendors, and internal staff to ensure successful conduct of the clinical trial including being the point of contact for issue escalation and resolution
Contributes to individual and team development through training initiatives, team building activities and mentoring and training of junior staff members
Writes and/or reviews Standard Operating Procedures (SOPs) for the Clinical Operations Department including study or site related documentation
Promotes and develops corporate initiatives for the Clinical Operations Department
Requirements
Minimum RN or Bachelor's degree in a scientific discipline
Proven track record in managing clinical operations activities and staff
8+ years of experience leading multiple global cross-functional clinical studies (Phases 1 -2, Phase 3 preferred) and vendors. Therapeutic medical device early development experience highly desired.
An understanding of and experience in the drug and medical device development process is required including: clinical program management, drug safety surveillance and reporting requirements, global regulatory reporting requirements, clinical study report requirements.
Working knowledge of ICH/GCP, ISO-14155, FDA, MDR, and EU Regulations, as applicable
Excellent team player with a proven track record in establishing working relationships with individuals from a broad range of backgrounds on cross-functional teams
Proven track record in managing, motivating and engaging with clinical staff
Advanced knowledge of the principles of project management, statistical data analysis and interpretation
Able to distill complex information from multiple sources and draw meaningful conclusions and insights
Represent the company with a high level of integrity and professionalism
High level of initiative and ability to work independently; self-motivated and achievement driven.
Ability to handle and prioritize multiple assignments in a fast-paced environment with changing priorities and meet deadlines and milestones
Strong verbal and written communication skills and adjusts content and style for audience; effectively delivers key messages; able to manage and communicate with cross-functional teams, stake holders and external vendors.
Extensive computer skills and use of Microsoft Office applications, including proficiency in MS Project. Requires strong word processing skills.
Ability to travel (domestically and internationally) up to 25%
إخلاء المسؤولية: د.جوب هو مجرد منصة تربط بين الباحثين عن عمل وأصحاب العمل. ننصح المتقدمين بإجراء بحث مستقل خاص بهم في أوراق اعتماد صاحب العمل المحتمل.
نحن نحرص على ألا يتم طلب أي مدفوعات مالية من قبل عملائنا، وبالتالي فإننا ننصح بعدم مشاركة أي معلومات شخصية أو متعلقة بالحسابات المصرفية مع أي طرف ثالث. إذا كنت تشك في وقوع أي احتيال أو سوء تصرف، فيرجى التواصل معنا من خلال تعبئة النموذج الموجود على الصفحة اتصل بنا