Description
The Clinical Trial Manager II (CTM II) serves as the clinical functional lead, accountable for the clinical
monitoring/site management delivery of assigned study(ies). The position as defined by scope provides
leadership, mentoring, and technical support to the Clinical Operations team to ensure quality of
deliverables and achievement of financial goals
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.
Adheres to scope and routinely reviews Clinical Trial Management System (CTMS), Case Report
Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Data
Visualization dashboards (where available) to oversee site and study team conduct, to ensure timely
entry of all operational aspects (required visits/calls, duration, and frequency) according to plan, and
to oversee site and study team conduct and identify any risks to delivery or quality
Ensures quality of the clinical monitoring and site management deliverables within a project and
maintain proper visibility of its progress by the use of 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 study and where required participates in the
development of the study 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
The Clinical Trial Manager II (CTM II) serves as the clinical functional lead, accountable for the clinical
monitoring/site management delivery of assigned study(ies). The position as defined by scope provides
leadership, mentoring, and technical support to the Clinical Operations team to ensure quality of
deliverables and achievement of financial goals
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.
Adheres to scope and routinely reviews Clinical Trial Management System (CTMS), Case Report
Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Data
Visualization dashboards (where available) to oversee site and study team conduct, to ensure timely
entry of all operational aspects (required visits/calls, duration, and frequency) according to plan, and
to oversee site and study team conduct and identify any risks to delivery or quality
Ensures quality of the clinical monitoring and site management deliverables within a project and
maintain proper visibility of its progress by the use of 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 study and where required participates in the
development of the study 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
Qualifications
Bachelor’s degree or RN in a related field or equivalent combination of education, training and
experience
Demonstrated ability to lead and align teams in the achievement of project milestones, demonstrated
capability of working with global team members.
Knowledge of basic 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.
Consistently clear and effective communication, presentation and interpersonal skills, among project
team, sites, and sponor.
Ability to apply problem solving techniques to 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 adaptability to change; new processes, systems, etc.
Demonstrates critical thinking to determine the cause and appropriate solution in the identification of
issues
Moderate travel may be required, approximately 20%