| 職務内容 |
Manage a team of clinical researching monitoring professionals and clinical related activities.
【Key Responsibilities】
・Manage and oversee the work of assigned team within own function and may indirectly manage cross functional or matrix teams as appropriate. Responsible for team budget and outside contractors/vendors. Develop a robust talent development plan in alignment with functional growth strategies of the department
・Lead on the strategic direction of field monitoring of studies and data collection for clinical trials (e.g., increased volume, upstream clinical projects) with increased volume and complexity (e.g., KOL site), act as a Core Team lead, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
・Provide guidance to team for clinical trial conduct improvements including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence
・Lead in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities Act as a mentor to new or other employees across the company
・Lead team members to take appropriate actions on complex trial monitoring issues (e.g., CAPA) and review escalated monitoring visit reports
・Participate and contribute to the development of clinical protocols, and informed consent forms, and case report forms
・Resolve complex trial/study data and regulatory documentation
・Provide direction and guidance to execute project deliverables in collaboration with project managers
・Initiate and lead the implementation on clinical process improvement opportunities
・Other incidental duties
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| 応募要件 |
【Education and Experience】
Bachelor's Degree or Equivalent in in related field with previous field monitoring experience, quality assurance/control and regulatory compliance Required and
Demonstrated track record in people management Required
Master's Degree or equivalent Experience working in a regulated industry Preferred
【Additional Skills】
・Proven expertise in MS Office Suite, including Word, Excel, and Adobe
・Experience with electronic data capture preferred
・Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
・Excellent problem-solving, organizational, analytical and critical thinking skills
・Expert understanding of clinical studies procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
・Expert understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
・Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
・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 work and excel within a fast paced, dynamic, and constantly changing work environment
・Frequently interacts with customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team
・Participate and present at meetings with internal and external representatives
・Resolve operational and scheduling issues
・Dedicated to quality client service and pro-active and responsive to client needs.
・Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
・Develop relationships and leverage them to influence change
・Support and solicit input from team members at all levels within the organization
・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
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