Clinical Trial Manager II.
Barcelona.
Clinical Trial (22004215)DescriptionSenior Clinical Trial ManagerCome discover what our 25,000+ employees already know: work here matters everywhere.
We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world.
Because to us, a patient isn't just a number, they're our family, friends, and neighbors.Why Syneos Health#SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves.
Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.We believe our success is a direct result of the people who are driving it - you!
We value your dedication to care for our customers and patients, so we want to focus on taking care of you.
That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.We are continuously building the company we all want to work for and our customers want to work with.
Why?
Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.Job responsibilitiesAs 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.
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