Senior Manager, Clinical Data Management

Join Takeda as a Senior Manager, Clinical Data Management, you oversee a medium-sized team of managers, supervisors, professionals, and specialists working on diverse topics. While actively involved in daily operations when necessary. You will also provide strategic guidance, act as an advisor and trainer to your team, and make decisions guided by the sub-function business plans. Your responsibilities include managing projects, budgets, schedules, and performance standards, as well as engaging with internal and external stakeholders at various management levels and presenting findings at meetings.

The Senior Manager Clinical Data Management is responsible for overseeing a team of professionals in the development, evaluation, and testing of clinical data management processes. This role ensures that clinical trials are conducted efficiently and in compliance with regulatory standards, contributing to Takeda's mission of bringing better health to people and a brighter future to the world.

• Oversee and manage a team of clinical data management professionals
• Ensure clinical trials are conducted in compliance with regulatory standards
• Develop and implement process improvement strategies for clinical data management
• Provide strategic guidance and act as an advisor and trainer to the team
• Manage projects, budgets, schedules, and performance standards
• Engage with internal and external stakeholders at various management levels
• Present findings and updates at meetings

• Preferred bachelor’s degree with 6+ years, or master’s degree with 3+ years of relevant industry experience in CRO or Pharmaceutical or a related discipline.
• Fully capable of performing complex clinical trials independently, providing recommendations for improvements and coaching others.
• Proficient in using Electronic Data Capture systems in highly complex situations, capable of advising others and recommending improvements.
• Performs advanced data validation tasks independently, capable of improving validation processes and mentoring others in basic techniques.
• Advanced in auditing, capable of handling highly complex situations, making improvement recommendations, and coaching others.
• Advanced understanding and application of Good Clinical Practices, capable of leading clinical trials and mentoring others on compliance and ethical considerations.
• Fully capable of performing and improving clinical data management processes, can apply knowledge in highly complex situations and guide others.
• Fully independent in clinical research, capable of guiding others and making improvement recommendations in complex situations.
• Excellently manages tasks requiring high attention to detail, independently addresses complex scenarios, and advises others on maintaining precision.
• Fully independent in data cleansing, capable of handling highly complex situations and making improvement recommendations, can coach others.
• Capable to independently managing and improving organizational structures and processes, can coach others in effective organization.

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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