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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:
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:
1 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.
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. May be delegated
by study team to initiate document development for global/regional studies.
4 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.
5 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.
6 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.
7 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.
8 May submit requests for vendor services and required to support vendor selection.
9 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.
10 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.
11 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.
12 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.
13 Reviews and approves site and local vendor invoices as required. Manages local study
supply, as required. Expected to guide Associate LTMs.
14 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.
15 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.
16 Works with SM to ensure CAPA is implemented for audits and inspection or any quality
related visits.
17 Complies with relevant training requirements.
18 Acts as subject matter expert for assigned protocols. Develops strong therapeutic
knowledge to support roles and responsibilities. May represent GCO on cross functional
teams.
19 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.
20 Actively leads or contributes to process improvement, training and mentoring of CTAs, SMs
and other LTMs
21 May be asked to conducts accompanied site visits with SM as delegated by FM/CRM. May
be required to provide guidance to Associate LTMs.
22 Expected to assume additional responsibilities or special initiatives such as “Champion” or
“Subject Matter Expert”.
23 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.
