Senior Manager, Study Management

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 activities for complex and/or business-critical clinical studies (including providing clinical study management expertise, study and CRO oversight, issue escalation, and resolution).
• Act as a role model for Takeda´s values.

EDUCATION AND EXPERIENCE:

• Bachelor’s Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable.
• 8 or more years experience in the pharmaceutical industry and/or clinical research organization.
• Prior experience in line management preferred and/or leadership experience as a mentor/supervisor or cross functional matrix leadership.
• Familiar with requirements for clinical trials (ICH/GCP) and regulatory submissions.
• Ability to manage a team to meet company objectives.
• Ability to work independently, take initiative, establish priorities, complete tasks to deadlines.
• Strong communication skills and customer focus with ability to interact in a global, cross-functional organization.
• Proven ability to communicate effectively and respond to inquiries and concerns, support issue escalation and proprose mitigation strategies where feasible.
• Must be able to work in a fast-paced environment with demonstrated ability to prioritize multiple competing tasks and demands.
• Demonstrated ability to be flexible and to adapt quickly to change.
• Excellent teamwork, organizational, interpersonal, and problem solving skills.
• Fluent business English (oral and written).