Local Trial Manager

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Global Clinical Operations (GCO)

Local Trial Manager

Position Summary:
The Local Trial Manager II (LTM II) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The LTM II 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 LTM II 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 LTM II actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and LTM I roles. The LTM II may have some site management responsibilities. The LTM II may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL)



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 CTM/GTL. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.

2. Collaborates with the Global Product Lead (GPL), CTM/GTL, 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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7onf88