Manager, FSP 360

Syneos Health, Inc.; Buenos Aires; Presencial; ARS 136.577.000 - 182.102.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Manager, FSP 360 to oversee clinical monitoring and site management deliverables, ensuring quality and on-time performance. You will interact with clients and cross-functional teams to maintain alignment with study plans and budgets.

The role includes delivering protocol-specific training, overseeing SDV and data plans, and ensuring GMP/ICH compliance across sites, with leadership over CMP/SMP execution.

Formación

• Manages quality of clinical monitoring and site management deliverables.
• Ensures alignment of activities to budget and timelines.
• Provides training on study protocols, CRFs, SOPs, and data plans.

Responsabilidades

• Interact with client and clinical functions for monitoring activities.
• Oversee CMP/SMP and risk plans; ensure regulatory compliance.
• Lead regular study team meetings and status updates.

Conocimientos

Clinical monitoring

Site management

Budget alignment

Training delivery

SOP adherence

Herramientas

CTMS

TMF

Data Visualization

Descripción del empleo

Manager, FSP 360Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.Discover what your 25,000 future colleagues already know:Why Syneos Health• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.Job ResponsibilitiesEnsures 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).•Interacts with the client and other functional departments related to clinical monitoring and site management activities and deliverables.•Ensures alignment of clinical activities to budget, including identification of out of scope activities.•May participates in business development proposals, defense meetings and proposal development.•As required, provides development and delivery of 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. Plans and leads regular clinical study 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.•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.•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 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.•Adheres to scope to ensure assigned clinical staff routinely assess site processes, perform review of all Source Documents and medical records, and perform Source Document Verification (SDV) per the CMP/SMP and reviews identified and newly emerging risks. Develops and executes corrective action plans at site and study level, proportionate to the risks identified. Utilizes systems and tools to assess Key Risk Indicators (KRIs) and ensures that monitoring visits/calls are occurring in line with CMP/SMP. Proactively collaborates with the data management functional lead to plan towards data cut and lock deadlines.•Collaborates with other functions 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.Get to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.http://www.syneoshealth.comAdditional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.