Clinical Trial Manager I Barcelona. Sponsor dedicated and previous experience as Lead CRA. (22001826)
Description Come 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 responsibilities 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 maintains 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.Equal Opportunities Plan. Its objective is to achieve the principle of equality of opportunity in Syneos Health's employment practices ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions.
Qualifications What we're looking for:
Bachelor's degree or RN in a related field or equivalent combination of education, training.
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