【800～1500万円】■Clinical Trial Manager（～Senior）

【求人No NJB2287016】
JOB SUMMARY
The Senior Clinical Trial Manager （ CTM） serves as the clinical functional lead accountable for the clinical
monitoring/site management delivery of assigned tasks and project（s） as per scope. The Senior CTM may
provide oversight and coordination of CTM（s） working across regions and/or countries to ensure clinical
project and site deliverables are met. The position provides leadership mentoring and technical support
to the Clinical Operations team to ensure quality deliverables and achievement of milestones and
financial goals. May provide administrative line management which includes oversight of training
compliance performance development and career management of direct reports.
JOB RESPONSIBILITIES
As defined by scope may be responsible for team member clinical/site management project deliverables
as the clinical functional team leader. Drives and manages the clinical and site management aspects of
assigned project. May be a standalone lead or part of a regional or global clinical functional lead team.
Reviews the study scope of work budget and protocol content and ensures the clinical project team
（CRAs/CMAs/SMAs） is aware of the parameters. Escalates to the PM any clinical/site management
deliverables （timeline quality and budget） at risk and any activities and requests which are out of
contracted scope. Ensure alignment of clinical activities to budget including identification of out of scope
activities.
・ Globally reviews Clinical Trial Management System （CTMS） Case Report Form （CRF） drug
management safety Trial Master File （TMF） IVRS/IWRS enrollment Strategic Data Monitoring
（SDM） and/or other dashboards to oversee site and project team conduct ensures timely entry of
all operational aspects （required visits duration and frequency） according to plan and identifies
risks to delivery or quality.
・ Coaches and mentors CTMs regarding functional clinical delivery evaluation of project risks and
action implementation. Also sets priorities for the CTM team to complete and manage on a regional
and site level.
・ Ensure quality of the clinical monitoring and site management deliverables within a project and/or
program and maintain proper visibility of its progress by the use approved systems and / or tracking
tools. May include the development of the Clinical Management Plan （CMP）/Site Management
Plan （SMP）.
Understands the monitoring strategy required for the project and where required participates in the
development of the project risk assessment plan. Is accountable for the clinical teams’
understanding ongoing compliance and delivery according to the stated monitoring strategy
CMP/SMP and risk plans
・ Reviews the content and quality of site monitoring documentation （site monitoring calls site visit
reports site letters and pertinent correspondence） to ensure they represent site management
activities and conduct. Ensures these deliverables are provided according to company and/or
sponsor specifications including delivery deadlines
・ Maintains compliance on the project（s） for performance deliverables and associated KPIs.
・ Interact with the client and other functional departments related to clinical monitoring and site
management activities and deliverables.
・ Collaborates with other functional areas to ensure site compliance and delivery according to
protocol ICH/GCP and/or Good Pharmacoepidemiology Practices （GPP） and country regulations
including medical monitoring Safety Quality Assurance （QA）. Ensures Inspection Readiness for
Clinical Scope.
・ Ensures alignment of clinical activities to budget including identification of out of scope activities.
・ As required provides development and delivery of initial and ongoing training to the study team
regarding protocol specifics Case Report Form （CRF） completion Sponsor Standard Operating
Procedures （SOPs） clinical plans and guidelines data plans and timelines for the project. Plans
and leads regular clinical project team calls to provide status updates ongoing training and
accountability to deliverables.
・ As defined by scope may oversee the global project process and status of monitoring and data flow.
Reviews status and trends at the study level holds CTM team accountable to manage at site and
regional level for effective and timely Source Document Review （SDR） and/or Source Document
Verification （SDV） and data flow reviewing status of site and project eCRF entry SDV triggered
monitoring conduct query response and data cleanliness. Proactively collaborates with data
management functional lead to plan towards data cut and lock deadlines. Develops and executes
corrective action plans at study （global） level to address any issues.
・ May evaluate staff’s competency to perform visits/site contact independently via sign off visits and
Monitoring Evaluation Visits （MEVs） according to company standards and process.
・ May participate in business development activities including project clinical operations/site
management strategy and budget input defense meetings and proposal development.
・ May be involved in Business Unit or corporate initiatives serving as a Clinical Operations SME.

Bachelor’s degree or RN in a related field or equivalent combination of education training and
experience
・ Prior line management experience preferred
Demonstrated ability to independently lead and align teams in the achievement of project milestones
demonstrates accountability and ability to manage a global clinical operations team.
・ Knowledge of clinical project financial principles
・ Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
・ Must demonstrate good computer skills and be able to embrace new technologies
・ Excellent communication presentation and interpersonal skills among all internal and external
customers
・ Subject Matter Expert of Clinical Operational process and delivery. Apply problem solving techniques
to independently resolve complex issues and apply a risk management approach to identifying and
mitigating potential threats to the successful conduct of a clinical research project
・ Demonstrates critical thinking to determine the cause and appropriate solution in the identification of
issues. Able to present solutions and influence other stakeholders to accept those recommendations.
・ Moderate travel may be required approximately 20%
・ Demonstrates adaptability to change and serves as change agent to lead team members to adoption