• Prepare drafts of the following documents and complete after reviewing CPM.
• Prepare a protocol (including protocol synopsis) and a draft of the informed consent form and revise them in consultation with CPM and the other related divisions 
• Prepare drafts of documents on clinical matters to be submitted to the regulatory authority (PMDA consultation material, etc.)
• Prepare a draft of a reply to PMDA inquiries on clinical matters.
• Prepare materials for Pre-analysis review and medical review in cooperation with CPM and Japan CRA Lead.
• Attend GCP inspection, correspond to questions from the regulatory authority, and prepare a draft of replay to inquiries items.
• Cooperation with CPM, to correspond to In-house and On-Site Audit.
• Support Data review meetings or Medical Review meetings.
• Lead the preparation of the following documents or review 
• Coach CRA for remarks from IRB 
• Coach CRA for the documents to be submitted to the study site

Skills: Document Drafting, Protocol Development, Regulatory Documentation, GCP Compliance, Audit Collaboration, Data Analysis Support, CRA Coaching, IRB Communication

• Coordination of clinical studies conducted on in vitro diagnostic devices may also be studies through Contract Research Organizations
• Planning, executing, and reporting of studies according to applicable regulatory requirements and company procedures including study protocol preparations, start-up activities at study sites, ethical approvals, study monitoring, and reporting of results
• Acts as a member of a project team to contribute towards efficient management of clinical studies
• Monitoring of global clinical evidence requirements and development of internal clinical study management procedures
• Additional responsibilities may include tasks within the Regulatory Affairs
• Participating in the selection, training, and evaluation of personnel to ensure efficient operation of the functional area, with updates / metrics to management 
• Participating in mentorship and career development of the assigned personnel
• Effectively work cross-functionally with internal and external parties to ensure study plans and progress align with business objectives.
• Apply advanced knowledge of clinical research and GCP to develop practicable solutions to a wide variety of difficult problems.
• Ensure compliance of trials with all department, company, and regulatory policies, procedures, standards and/or guidelines.

Skills: Clinical Study Coordination, Regulatory Compliance, Project Team Collaboration, Global Monitoring, Regulatory Affairs Understanding, Personnel Management, Cross-functional Collaboration, Advanced Clinical Research Knowledge

• Responsible for overall operations of clinical studies including planning, management and implementation to meet project milestones.
• Utilize clinical systems such as CTMS, eTMF, and EDC for study management and execution.
• Responsible for development of Investigator Brochures, monitoring plans, clinical trial protocols, study plans and training materials, and oversight of CRF and clinical study report development.
• Responsible for assessment and selection of clinical trial sites and monitoring or co-ordination of study monitoring.
• Assist with estimation of costs of proposed trials, recording spend during projects, and managing against budget.
• Support data management activities including database development input and user acceptance testing.
• Management of investigational product, drug and ancillary equipment supplies and logistics.
• Responsible for training of study sites which may include clinical case support.
• Development of expertise in ear, nose and throat (ENT) technologies and therapeutic areas.
• Represent clinical function on product development teams and contribute to risk management processes.
• Review clinical study reports(CSRs), investigational brochure(IB), statistical analysis plans(SAP), and other clinical-study-related documents.

Skills: Project Management, Clinical Systems, Protocol Development, Site Monitoring, Budget Management, Data Management, Supply Logistics, Training Development

• Developing a project plan and defining operational guidelines for each study managing each study per project plan, including timelines and budget
• Organizing and managing internal team meetings, study-specific meetings, and meetings with sponsors / vendors / partners as applicable
• Attending cross-functional meetings as need to represent a specific study or Clinical Operations functional area
• Proactively identifying potential study issues and / or risks, providing recommendations, and implementing solutions
• Participating in the development, review, and implementation of standard operating procedures and processes
• Preparing and delivering study-related information to study teams and sponsors / vendors / partners
• Recruitment, screening, and enrollment reports
• Expectations and updates regarding timelines
• Summary of issues and resolutions
• Summary reports of data flow, protocol deviations, safety reports, and other reports as applicable
• Understand the contents of academic articles and CSRs in the assigned field

Skills: Project Management, Meeting Coordination, Cross-functional Representation, Risk Management, SOP Development, Information Dissemination, Reporting and Analytics, Academic and Clinical Research Understanding

• Overseeing clinical research conduct, including study start-up, enrollment, execution, and close-out
• Overseeing all operational aspects of assigned clinical studies
• Preparing, reviewing, and maintaining study related and essential documents (e.g. Form FDA 1572, financial disclosure forms, study manuals, etc.)
• Coordinating IRB correspondence and communication, ensuring that all approvals are obtained 
• Managing study supplies and equipment
• Organizing / ensuring that appropriate study trainings are delivered
• Ensuring that the necessary electronic systems are configured as needed for each study
• Ensuring that the vendors / personnel needed for each study are prepared, available, and trained
• Working with internal and external study monitors to address issues and provide resolutions
• Acting as the main point of contact for study investigator, study personnel, and sponsors/vendors / partners to ensure smooth communication and collaboration
• Review data at Data review meeting and Medical Review meeting.

Skills: Regulatory Compliance, Document Management, Supply Chain Oversight, IRB Communication Coordination, Training Coordination, System Configuration, Vendor and Personnel Management, Stakeholder Communication

• Study Management/Project Management skills
• Demonstrates understanding and quality delivery of study milestones according to established timelines
• Ability to handle complex projects/problems
• Ability to identify investigational sites and investigators
• Strong negotiation and professional communication skills
• Professional communication skills, strong oral and written English
• Advanced knowledge and application of medical device industry standards and best practices in clinical data management and applicable country regulations (NMPA, ISO, ICH, etc.)
• Attention to detail
• Product and indication/disease knowledge, understanding basics of other/implant/surgical procedures

Qualifications: BA in Healthcare Administration with 6 years of Experience

• Combined experience in pharmaceutical industry, and academic research, or healthcare management.
• Management experience in Global Medical Affairs or related field desired
• Demonstrated understanding of legal, compliance, and regulatory guidelines related to the conduct of a variety of types of research trials in the pharmaceutical industry.
• Experience working in a global organization highly desirable.
• Experience working in a matrixed environment highly desirable.
• Have solid interpersonal skills with a communicative and flexible attitude.
• Excellent organizational and problem-solving skills with the capacity to organize assignments and work within deadlines.
• Ability to work well under pressure while maintaining a professional demeanor
• Multidiscipline (at least 2 specialties) therapeutic knowledge.

Qualifications: BA in Clinical Research with 9 years of Experience

• Clinical operations experience gained working in a pharmaceutical/biotechnology industry environment, with a strong preference for immunology, allergy, dermatology and/or biologics experience
• Working knowledge of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs
• Proven ability to plan, conduct and manage clinical operations from early through late phase trials, with global trial experience 
• Demonstrated ability to manage CROs, central laboratories, and other clinical study vendors.
• Ability to contribute to the development of clinical protocols, project-related documents, clinical study reports and summary documents for regulatory submissions.
• Demonstrated ability to handle a high volume of highly complex tasks within a given timeline
• Demonstrated, effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize.
• Effective communication and interpersonal skills, with the ability to successfully articulate plans, results and analysis to project teams and senior management to build commitment and alignment, listens and seeks clarification, responds effectively to inquiries or complaints.

Qualifications: BS in Biology with 7 years of Experience

• Clinical Operations experience in a professional life sciences environment
• Experience with oncology clinical trials in the biopharmaceutical or diagnostic industry, or in an academic center
• Excellent knowledge of applicable standards and regulations for clinical trials and laboratory conduct (CFR, ICH-GCP, Federal guidelines, GMP, GLP, ISO, etc.)
• Knowledge and experience working in MS Office Suite, Google Suite
• Proven history of successfully managing multiple concurrent initiatives and maintaining one's own workflow in a fast-paced, dynamic environment
• Demonstrated evidence of success working in a cross-functional environment
• Able to build strong relationships
• Strong organizational skills
• Ability to build strong relationships with external parties, such as key opinion leaders and clinical investigators.

Qualifications: BA in Public Health with 6 years of Experience

• Project management experience.
• Fluency in English and local language
• Project management experience with complex multicenter OUS trial.
• Knowledge of Good Clinical Practices 
• Knowledge of regulations that apply to medical device trials at various stages of development (feasibility, pivotal, post-market) and ability to adapt trial oversight accordingly.
• Familiarity with all aspects of the clinical trial process including, but not limited to protocol, development, site selection/qualification, site initiation, monitoring, close-out, investigator meetings, DSMB/CEC, core lab management.
• Understanding of site escalation process for compliance issues.
• Familiarity with medical device development process from pre-clinical to commercialization.

Qualifications: BS in Biochemistry with 5 years of Experience