Manager, Clinical Research Monitoring
Imagine how your ideas and expertise can change a patients life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients lives. As part of our Clinical Affairs team youll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in close partnership with principal investigators dedicated medical professionals patient advocacy groups and regulatory authorities you will drive the evidence needed to optimize patient outcomes.
How you will make an impact:
Applies subject-matter expertise and guidance to advance clinical project management activities and leadership decision making.
Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables in accordance to GCP all applicable regulations and SOPs. Serve as the primary lead of assigned clinical trial(s)
Provide direction guidance and oversight of clinical core teams to execute projects and initiatives
Manage project status and appropriate communication both internally and externally
Analyze trial performance to plan and develop corrective actions. Identify and communicate study risks recommend and lead in the implementation of mitigation strategies in collaboration with management
Oversee the selection of clinical vendors and study sites
Provide mentoring and coaching to other project team members
Other incidental duties
What youll need (Required):
Bachelors Degree in in related field 8 years experience of previous related experience required
Business English proficiency and Native Japanese language skill
Proven successful project management skills
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Extensive knowledge of own area within the organization while contributing to the development of new concepts techniques and standards
Extensive knowledge and understanding of Edwards policies procedures and international and domestic medical device regulatory guidelines relevant to clinical protocols
Extensive understanding of regulatory submissions reporting and audits
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to manage competing priorities in a fast paced environment
Represents leadership on sections of projects within a specific area interfacing with project managers and clinical team
Consult in project setting within specific sections
Provides leadership to outsourcing partners on a task level
What else we look for (Preferred):
Experience working in a large manufacturing company
Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System) eTMF (electronic Trial Master file)
Adhere to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Other: Certification in related discipline
Required Experience:
Manager
Employment Type : Full-Time
Experience: years
Vacancy: 1