Clinical Trial Manager

**Description**

**JOB SUMMARY**

**The Clinical Trial Manager serves as the clinical functional lead, accountable for the clinical monitoring/site management delivery of assigned study(ies). May be regional lead based on size and complexity of project, or support lead under mentoring or supervision of an experienced CTM. 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 and delegated tasks as assigned by the clinical functional team leader. Supports the clinical and site management aspects of assigned project. Serves as part of a regional or global Clinical Lead team. Reviews the study scope of work, budget and protocol content and helps to ensure the clinical project team (CRAs/CeMs/SMAs) is aware of the parameters. Escalates to the assigned regional or global Clinical Lead any assigned clinical/site management deliverables (timeline, quality, and budget) at risk, and any activities and requests which are out of contracted scope. May operate as the clinical functional lead under the mentorship of a CTM.
- Supports primary study Clinical Lead in routine reviews of 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. Oversees assigned site and study team members' conduct, and identifies 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.
- Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. Is accountable for their assigned clinical team members' 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.
- Interacts with the client and other functional departments related to clinical monitoring and site management activities and deliverables.
- Demonstrates understanding of other functions' roles in achieving site compliance and delivery according to protocol, ICH/GCP and or Good Pharmacoepidemiology Practices (GPP) and country regulations. This may include medical monitoring, Safety, Quality Assurance (QA). Supports Inspection Readiness for Clinical Scope.
- Understands budgeted clinical activities in order to identify out of scope activities
- Supports study tool and template development. Delivers initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.
- Oversees assigned clinical staff routinely to assess site processes, perform review of all Source Documents and medical records, and perform Source Data Review (SDR) and/or Source Document Verification (SDV) per the CMP/SMP and reviews identified and newly emerging risks. May develop and support execution of corrective action plans at site and study level, in accordance with the risk based monitoring strategy outlined in the CMP/SMP. Supports and completes activities to achieve data cut and lock deadlines.
- May evaluate staff’s competency to perform visits/site contact independently via sign-off visits and Performance Assessment Visits (PAVs) according to company standards and process.
- Proactively engages in feedback opportunities that support BU level initiatives

**QUALIFICATION REQUIREMENTS**
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Demonstrates ability to lead and align teams in the achievement of project milestones, demonstrates capability of working in an international environment.
- Demonstrates learning of basic clinical project financial principles
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills
- Good communication, presentation and interpersonal skills among project team and with sites
- Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues
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