JOB SUMMARY

The Senior Clinical Operations Lead (COL) 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 COL may provide oversight and coordination of COL(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

· 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).

· Interact with the client and other functional departments related to clinical monitoring and site management activities and deliverables.

· May participate in business development activities including project clinical operations/site management strategy and budget input, defense meetings and proposal development.

· 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.

· 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.

· Coaches and mentors COLs regarding functional clinical delivery, evaluation of project risks, and action implementation. Also sets priorities for the COL team to complete and manage on a regional and site level.

· 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.

· 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.

· 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

· 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.

· 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.

· 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 COL team accountable to manage at site and regional level for effective and timely 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.