Local Trial Manager

Description: The Local Trial Manager I (LTM I) role is responsible for local management of a clinical trial in a country. The LTM I acts as 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 I 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.

An LTM 1 may contribute to process improvement activities and the training of Clinical Trial Assistants (CTA) and Site Managers (SM).

An LTM I will usually perform principal responsibilities under the direct supervision of an LTM II or III and/or Functional Manager (FM)/Clinical Research Manager (CRM).

Principal Responsibilities

• Collaborate with FM/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.

• Collaborates with the Global Project Lead (GPL), Clinical Trial Manager (CTM)/Global Trial Lead (GTL),
  
  

local management/Country Head and other study team member to select final site list.

• 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.

• Leads and coordinates local trial team activities in compliance with GCO Standard Operating Procedures
  
  

(SOP), other procedural documents and applicable regulations. Leads local project planning activities to

meet recruitment targets and to deliver high quality data on time and within study budget. Including

but not limited to: development of local trial specific procedures and tools, recruitment planning,

contingency and risk management, and budget forecasting.

• Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs)
  
  

are reported within the required reporting timelines and documented as appropriate.

LD Version 1.1 dated 22 March 2022(FINAL) For Internal Use Only

10001466 Specialist 2, Clinical Trial Admin/Oper (PG 24) – US Only

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• Maintains and updates trial management systems. Uses study tools and management reports available
  
  

to analyse trial progress.

• Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial
  
  

deviates from plans and communicates study progress and issues to study management teams.

• May submit requests for vendor services and may support vendor selection
• In certain situations, may assist in negotiation of trial site contracts and budgets. Forecasts and
  
  

manages country/local trial budget to ensure accurate finance reporting and trial delivered –within

budget. Adheres to finance reporting deliverables and timelines.

• Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country
  
  

investigator meeting.

• Conducts local trial team meetings and provides or facilitates SM training when needed (i.e.
  
  

implementation of study amendment-and changes in study related processes).

• Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across
  
  

a trial project and escalates deviation issues to the CTM/GTL and FM as needed

• Reviews and approves site and local vendor invoices as required. Manages local study supply, as
  
  

required.

• Prepares country specific informed consent in accordance with GCO procedural document/templates.
  
  

Reviews and manages site specific informed consent forms in accordance with GCO SOPs, other

procedural documents and applicable regulations.

• Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is compliant with local
  
  

regulatory requirements.

• Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits
• Complies with relevant training requirements.
• Acts as subject matter expert for assigned protocols. Develops strong therapeutic knowledge to
  
  

support roles and responsibilities. May represent Global Clinical Operations on cross functional teams.

• Acts as primary local/country contact for a trial. Establishes and maintains excellent working
  
  

relationships with external stakeholders, in particular investigators, study trial coordinators and other

site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials.

• Conducts accompanied site visits with SM as delegated by FM.
• Contributes to process improvement.
  
  

Qualifications: A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.

Minimum one to two years of pharmaceutical and/or clinical trial experience is preferred (including site

monitoring experience), however, other relevant experiences and skills may be considered by the hiring

manager when considering the candidate’s eligibility.

Specific therapeutic area experience may be required depending on the position. Should have a basic

understanding of the drug development process including ICH/GCP and local regulatory requirements.

Willingness to travel with occasional overnight stay away from home.

Some leadership skills. Good communication and computer skills required. Proficient in speaking and

writing the country language and English language. Good written and oral communication skills.