Manager ,Clinical Data Management

Responsible for clinical data management (CDM) strategy, execution, and staffing for multiple clinical trials and PMS within THV Clinical Affairs within a region. Is knowledgeable regarding regulatory policies and applies this knowledge to CDM processes. Ensures CDM deliverables are of high quality and are provided in a manner to support the overall Clinical Strategy.

Key Responsibilities:
• Manage a small team of clinical data management SMEs to maintain project assignments, set goals and expectations, and provide issue resolution support to direct reports.
• Plan, organize, and coordinates internal and external data management activities to support assigned clinical trials in accordance with regulatory and company guidelines. Works cross functionally to provide support to clinical study projects. successful completion of assigned deliverables.
• Assist in hiring, development and evaluation of direct reports to increase their business acumen and functional knowledge.
• Reviews and develops workflow and work process standards to ensure that data management activities are in compliance with regulatory and company requirements.
• Leads process improvement projects within CDM and across functional areas.
• Writes, revises, reviews, and edits new or existing SOPs, work instructions, forms, and templates as needed.
• Other duties as assigned by leadership

Education and Experience:
Bachelor's Degree in in related field with related experience in clinical data management Required
Master's Degree or equivalent in related field Preferred
Certification in related field Preferred
in Experience working in a regulated industry Preferred

Additional Skills:
• Proven successful project management leadership skills
• Proven expertise in Microsoft Office Suite and related tools and systems
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making

• Excellent written and verbal communication skills in English and Japanese, and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• 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