Sr Local Trial Manager

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Job Function:
R&D Operations

Job Sub Function:
Clinical Trial Project Management

Job Category:
Professional

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

Sr Local Trial Manager

Position Summary:
A Senior, Local Trial Manager is a mid-level trial management role with typically at least 2 years of clinical trial management or 3-5 years for clinical monitoring experience.

This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries.

The Senior, Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents.

The Senior, Local Trial Manager is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.

The Senior, Local Trial Manager actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and Associate, Local Trial Managers.

The Senior, Local Trial Manager may have some site management responsibilities.

The Senior, Local Trial Manager may also perform the role of Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL) for single country as described in GCO procedural documents.

Principal Responsibilities:
1.

Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and TDM/TDL.

Implements any local criteria for site selection.

Ensure consistent conduct of Site Qualification Visits and instruct teams on appropriate follow-up of Site Qualification Visit report and country feasibility report.

Recommends suitable sites for selection to participate in trial.
2.

Collaborates with the Program Delivery Leader (PDL), TDM/TDL, local management/Country Head and other study team member to select final site list.
3.

Contributes input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs.
4.

Leads and coordinates local trial team activities in c...