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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:
Lead Local Trial Manager


Position Summary:

A Lead, Local Trial Manager is considered as a senior trial management role with at least 4 years of clinical trial management experience or more than 6 years of 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 Lead, 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 Lead, 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 Lead, Local Trial Manager actively leads or contributes to process improvement; training and mentoring of other LTMs and Site Managers (SM).

Compared to Associate, Local Trial Manager and Senior, Local Trial Manager roles, a Lead, Local Trial Manager is often assigned to more complex protocols and can work across Phase 1 – 3 studies in multiple therapeutic areas as needed to drive business needs.

The Lead, 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:

May be delegated by Functional Manager (FM)/Clinical Research Manager (CRM) to lead 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.

Collaborates with the Program Delivery Leader (PDL), TDM/TDL, 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.

May be delegated by study team to initiate document development for global/regional studies.
Leads and coordinates local trial team activities in compliance with SOPs, 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. Expected to guide Associate LTMs.

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.

Maintains and updates trial management systems. Uses study tools and management reports available to analyse trial progress. May be required to support Country Heads in generating country performance reports.

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 required to 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. Expected to guide Associate LTMs.
Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting. Will be expected to present and lead specific sessions and to facilitate discussion groups. May be required to be the organizer for Investigator Meetings.
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). May be required to provide guidance to Associate LTMs.

Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the TDM/TDL and FM/CRM as needed.

Expected to mentor and guide Associate LTMs.
Reviews and approves site and local vendor invoices as required. Manages local study supply, as required. Expected to guide Associate LTMs.
Prepares country specific informed consent in accordance with procedural document/templates. Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents, and applicable regulations. Expected to guide Associate LTMs.
Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements. Expected to guide Associate LTMs.
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 GCO 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.

Actively leads or contributes to process improvement, training and mentoring of CTAs, SMs and other LTMs.
May be asked to conducts accompanied site visits with SM as delegated by FM/CRM. May be required to provide guidance to Associate LTMs.
Expected to assume additional responsibilities or special initiatives such as "Champion" or "Subject Matter Expert".
Expected to represent functional area or lead country, regional, and global process initiatives as required.

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.


Principal Relationships:

Primary Reporting Structure:
Reports to a FM/CRM

Primary interfaces:
FM/CRM, CTA, SM, TDM/TDL, Study Responsible Physicians (SRP)/Study Responsible Scientists (SRS), Compliance Managers/Specialists, Local Safety Officer

Other Internal Interfaces:
R&D Country Head, Strategic Account Lead (SAL), Contracts & Centralized Services (CCS), R&D clinical team (e.g., SRP), data management and Medical Affairs (when applicable)

External Interfaces:
Health Authorities, Ethics Committees, Investigational sites, local vendors, and others as required.


Education And Experience Requirements:

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

Minimum of 6 years of clinical trial management experience or a total of at least 8 years of clinical trial monitoring and/or clinical trial management experience.

However, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.

Specific therapeutic area experience is required and essential particularly for key therapeutic area. Should have an in-depth understanding of the drug development process including GCP and local regulatory requirements.

Willingness to travel with occasional overnight stay away from home.

Minimum of 4 years of leadership experience. Computer skills required. Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills. Demonstrated ability to be consistently influential.

Strong experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs. Demonstrated ability to lead initiative/small teams.

Flexible mindset and ability to work in a fast-changing environment. Ability to work on multiple trials in parallel in different disease areas, if required. Ability to anticipate obstacles and proactively provide solutions.

Expected to be assigned to high priority and high complexity projects.

Oncology experience required (Internal applicants:
Oncology experience is not required)

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:

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.

Collaborates with the Program Delivery Leader (PDL), TDM/TDL, 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 SOPs, 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.

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 required to 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. Will be expected to present and lead specific sessions and to facilitate discussion groups.
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 TDM/TDL and FM/CRM 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 procedural document/templates. Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance 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 GCO 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.

Actively contributes to process improvement, training and mentoring of CTAs, SMs and other LTMs.
May be asked to conducts accompanied site visits with SM as delegated by FM/CRM. May be required to provide guidance to Assoc LTMs.
May assumes additional responsibilities or special initiatives such as "Champion" or "Subject Matter Expert".
May represents functional area in process initiatives as required.

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.


Principal Relationships:

Primary Reporting Structure:
Reports to a FM/CRM

Primary interfaces:
FM/CRM, CTA, SM, TDM/TDL, Study Responsible Physicians (SRP)/Study Responsible Scientists (SRS), Compliance Managers/Specialists, Local Safety Officer

Other Internal Interfaces:
R&D Country Head, Strategic Account Lead (SAL), Contracts & Centralized Services (CCS), R&D clinical team (e.g., SRP), data management and Medical Affairs (when applicable)

External Interfaces:
Health Authorities, Ethics Committees, Investigational sites, local vendors and others as required.


Education And Experience Requirements:

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

Minimum of 2 years of clinical trial management experience or a total of at least 5 years of clinical trial monitoring and/or clinical trial management 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 good understanding of the drug development process including GCP and local regulatory requirements.

Willingness to travel with occasional overnight stay away from home.

Minimum of 2 years of leadership experience. Computer skills required. Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills. Demonstrated potential to be influential.

Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred. The ability to lead initiative/small teams.

Flexible mindset and ability to work in a fast-changing environment. Ability to work on multiple trials in parallel. Ability to anticipate obstacles and proactively provide solutions.

May be assigned to high priority projects.

Oncology experience required (Internal applicants:
Oncology experience is not required)

Based on your experience and interview evaluation, the position title and level may vary.
If you are Japan employee, please read "Internal Application Guideline" in Ask GS.

Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR.

If you are Japan's employee, you are not able to apply for multiple positions at once.

For Employee Referral Program (ERP), please read and understand the details of the "Internal Referral Overview" on the Ask GS and you have made a compliant referral.

Required Skills:

Preferred Skills:
Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)
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