Senior Manager, Study Management

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Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as the Senior Manager, Study Management based remotely reporting to the Director, Study Management.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

• Responsible for direct line management of assigned study management team members for a given therapeutic area(s).
• Ensuring appropriate training of study management team members in order to deliver operational consistency and high quality support across clinical trial programs.
• Provide guidance and mentorship to support the development of skills, knowledge, and expertise.
• Supporting the execution of studies in a matrix management structure to ensure compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs).
• Serves as subject matter expert to support complex activities such as process development, complex program support or department and/or business critical initiatives and deliverables.

ACCOUNTABILITIES:

• Provide direct supervision of study management team members within assigned TA, including hiring/staff selection and assignment of individual studies, resource allocation, onboarding, overall training, completion of goals, development plans, performance reviews, and Talent Management.
• Overseeing study management team members to ensure proper execution of assigned studies.
• Responsible for ensuring compliance of assigned team members to Takeda SOPs and training of systems and quality standards, including inspection readiness in execution of Takeda studies and trials.
• Responsible for training, coaching and mentoring study management team members and new hires in navigating career progression options within Takeda.
• Provides performance feedback on an ongoing basis to support continued development growth.
• Demonstrate leadership to direct reports, ensuring employees adhere to corporate policies and following up with management as appropriate.
• Ensure compliance with pre-defined roles and responsibilities within a matrix management structure.
• Contributes to resource evaluations for study to ensure adequate resources are available for the successful delivery of clinical programs.
• Maintain a positive, results-orientated work environment, building partnerships and modeling teamwork, communicating with the teams and stakeholders in an open, balanced, and objective manner.
• Support Global Clinical Development Operations (GCDO) initiatives (including lessons learned/best practices process) to develop innovative processes and technologies to advance operations, ensure compliance and quality delivery, and reduce operating costs; Support cross-functional strategic initiatives and processes.
• Foster knowledge sharing and the use of best practices across the study management team and act as team superuser or subject matter expert for the company systems and processes.
• May directly support Clinical Operations Program Leads in day-to-day act