Local Study Manager

Local Study Manager

Grade: L2

Hiring Manager: Kentaro Obara, Head of Japan Clinical Operations, R&D

Location: Japan, Tokyo, 50% Remote working

Job type: Permanent

About the job

The LSM (Local Safety Manager) acts on country/cluster level as the key strategic interface with internal and external stakeholders to develop, implement, maintain, and improve operational processes to accelerate trial conduct in close collaboration with respective functions within CSU (Clinical Study Unit) and other departments, e.g. Medical Advisor, Site Engagement Manager, Strategic Start Up Manager, Medical Science Liaisons.

The LSM acts as Person of contact within a therapeutic area in terms of study management and conduct and leads a study team through change management efforts and by example. The LSM represents the LSM perspective for CSU in organization wide initiatives.

The LSM provides excellent study management which includes the ability to identify and anticipate risks jeopardizing the trial performance and to develop and initiate countermeasures based on proposer planning and regular revision of the plans. The LSM is working cross-countries or cross-clusters and covers satellite countries as well.

Responsibilities

Early participation to address operational aspects in the study country strategy in partnership with relevant parties to ensure a smooth and fast path to the First Patient In: Lead local study management at the country level from operational point of view starting with experience sharing during feasibility process, through end of the study according to global and local study plan: Oversees Study Budget at country/cluster level and ensures optimization and appropriate management of the financial resources: Promote effective communication between all parties involved in the study to align common goals and define effective strategies: Maintain Quality and Compliance through vendor oversight of all project deliverables according to project timelines and KPIs.:

Knowledge And Skills

Mandatory

• Knowledge of GCP/ICH phase I-IV clinical trials and observational studies
• Trained for Compliance and Business Integrity

Proficiency Level : Not needed (0), Foundational (1), Intermediate (2), Advanced (3), Game Changing (4)

• Risk Management Skills (2)
• Project Management Skills (3)
• Data Analytics (& Digital) skills (3)
• Medical / Scientific Background -Therapeutic Area / Disease knowledge (2)
• Clinical Development Process Knowledge (2)
• Problem-Solving skills (3)
• Business Acumen (Business Sense) (1)
• Change Management skills (2)
• Emotional Intelligence/good behaviors (3)
• Interpersonal & Relationship Management (2)
• Develop People & Lead Teams (1)

Formal Education And/or Experience Required:

• Bachelor’s degree or higher degree in Health or Natural Sciences or equivalent experience depending on the country.
• 3 years of experience in clinical research are mandatory, preferably in combination with experience in project management and certain time as field monitor or site coordinator
• Fluent in English
• Willing to travel.

Knowledge And Skills Desirable but Not Essential:

• Proficiency in complex trial management
• Broad scientific knowledge within several therapeutic areas
• Certification level of Project Management (PMP/PMI)
• International experience working with teams abroad (regulatory/communication)

Next Career

The potential next career for LSM is really diverse. LSM has a lot of opportunity to obtain the basic knowledge and skillset of clinical operation. For example, Medical Advisor, Clinical Innovation, Site Engagement, Project Leader/ Manager. LSM will also have chance to work as the role of Regional Study Manager to manage global study at region level.