Clinical Trial Manager - Regional or Global experience - Any country in EMEA
Syneos Health
PauClaris, 196, Barcelona, ESP, Spain
hace 5 días

Description

Clinical Trial Manager II

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

  • 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.

  • 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
  • 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.
  • May include the development of the Clinical Management Plan (CMP) / Site Management Plan (SMP).

  • 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

  • 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 in assigned region or project for performance, deliverables, and associated KPI’s.
  • Interacts with the client and other functional departments related to clinical monitoring and site management activities and deliverables.
  • 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

  • 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 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.

  • 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 Review (SDR) and / or 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.

  • May evaluate staff’s competency to perform visits / site contact independently via sign-off visits and Monitoring Evaluation Visits (MEVs) according to company standards and process.
  • May participate in business development proposals, defense meetings and proposal development.
  • May be involved in Business Unit-level initiatives
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