Empregos actuais relacionados com Centralized Monitor- French Speaker - Lisboa, Lisboa - IQVIA


  • Lisboa, Lisboa, Portugal QUANTEAM - Portugal (RAINBOW PARTNERS Group) Tempo inteiro

    Who are we?As the founding entity of RAINBOW PARTNERS, Quanteam is a consulting firm specializing in the fields of Banking, Finance, and Financial Services. Guided by our core values of closeness, teamwork, diversity, and excellence, our team of 980 expert consultants, representing 35 different nationalities, collaborates across 10 international offices:...


  • Lisboa, Lisboa, Portugal Velenosi&Meredith Tempo inteiro

    Customer Service Representative French Speaker Location: Lisbon, Portugal Schedule: Monday to Friday, Rotative Shifts (06:00 22:00) Work Model: On-Site Welcome Bonus: 2,000 eurosAbout the Role:We are looking for a French-speaking Customer Service Representative to join our team in Lisbon If you have excellent communication skills and a passion for helping...


  • Lisboa, Lisboa, Portugal DE SOUSA Tempo inteiro

    A new year is the perfect moment to embrace fresh beginnings and take a bold step toward a new job. Starting a new role means new opportunities to grow, learn, and challenge yourself in ways that can shape your future. Let this year be the one where you believe in your potential, step out of your comfort zone, and build a career path that truly inspires and...


  • Lisboa, Lisboa, Portugal QUANTEAM - Portugal (RAINBOW PARTNERS Group) Tempo inteiro

    Who are we?As the founding entity of RAINBOW PARTNERS, Quanteam is a consulting firm specializing in the fields of Banking, Finance, and Financial Services. Guided by our core values of closeness, teamwork, diversity, and excellence, our team of 980 expert consultants, representing 35 different nationalities, collaborates across 10 international offices:...


  • Lisboa, Lisboa, Portugal Gi Group Tempo inteiro

    We are recruiting a Quality & Training Specialist (fluent in French) for one of our clients in Lisbon.Your day to day:Development and implementation of standard methodologies of trainingProvide training classes to new employees and/or Service providing staff to ensure the quality of procedures according to the guidelinesLeverage the Learning Management...


  • Lisboa, Lisboa, Portugal Neotalent Conclusion Tempo inteiro

    Who are we:Neotalent Conclusion is one of the leading Iberian specialists providing services in Information Technology and Engineering services. As part of the Netherlands-based organization Conclusion, which has an ecosystem of over 25 companies and 3,600 employees, we are focused on increasing the technological capacity of our clients and the digital...


  • Lisboa, Lisboa, Portugal Savior Artigos Texteis Lda Tempo inteiro

    Are you a French speaker with experience in customer service, account management, or sales-oriented support roles? We are hiring French-Speaking Customer Success Advisors for a dynamic international project based in Lisbon.You will support French-speaking clients, manage account-related requests, and contribute to customer satisfaction and retention. This is...


  • Lisboa, Lisboa, Portugal Cross Border Talents Tempo inteiro

    Are you a French speaker with experience in customer service, account management, or sales-oriented support roles? We are hiring French-Speaking Customer Success Advisors for a dynamic international project based in Lisbon. You will support French-speaking clients, manage account-related requests, and contribute to customer satisfaction and retention. This...


  • Lisboa, Lisboa, Portugal Cross Border Talents Tempo inteiro

    Support customers by day, explore Lisbon by night your Mediterranean life starts hereDo you have C2-level French and are ready for a new adventure under the Portuguese sun? Were looking for enthusiastic and solution-oriented Customer Service Specialists to join our international team on-site in Lisbon.Whether its answering a call with a smile or solving a...

  • French Speaker

    Há 4 dias


    Lisboa, Lisboa, Portugal Bosch Tempo inteiro

    Company DescriptionThe Bosch group has more than employees around the world, present in 60 countries, and we are proud to impact people's lives and to work towards a more sustainable future.Bosch Service Solutions in Lisbon develops and offers Customer Experience, Mobility, and Monitoring solutions for its clients, and plays a prominent role in providing...

Centralized Monitor- French Speaker

2 semanas atrás


Lisboa, Lisboa, Portugal IQVIA Tempo inteiro
Job Overview
Manage the execution of the assigned clinical study (ies) from initiation through to closeout. Ensure that clinical study management and project deliverables are on time and is in accordance with standard operating procedures (SOPs), policies and practices. To provide project related support and assistance across multiple projects, sites and teams and review the structured clinical data output with access to medical charts. To ensure the work is conducted as per SOPs, Policies and Good clinical practice's and applicable regulatory requirements. Adherence to protocol, overall completeness, and readiness of the supplied patient information to the next level of patient review and follow the metrics and timelines. Facilitate efficient and effective review of Site Visit Reports and assure consistent standards of implementation for quality to meet or exceed quality standards. Ensure subject safety, data integrity, escalation of issues and timely and responsive feedback in compliance with IQVIA SOPs, International Conference on Harmonization - Good Clinical Practice (ICH GCP)  guidelines, protocol requirements and regulatory compliance. 
Develop and use of study management plans and/or risk-based monitoring specific tools and templates and/or other study specific plans to evaluate the quality and integrity of the study.  Support project management team to develop monitoring strategy including monitoring triggers/thresholds.  Manage the operational insight of the assigned project(s) and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.)

Essential Functions

  • Manage assigned sites and perform Subject Level Data Review independently, if required perform with both responsibilities as dual role.
  • Perform remote monitoring visits for assigned sites as assigned.
  • Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall readiness of the patient information for next level review.;
  • Perform Study specific analytics based on applicable study specific plans. Contribute in developing new analytics proposal as per customer's demand, Ability to write analytical inferences to add business value.
  • Manage the operational insight of the assigned sites/studies and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.).
  • With guidance, provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.
  • Identify the value adds from the centralized review & remote monitoring in the study and provide the inputs to relevant stakeholders.
  • Support CMS leads to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan.
  • Collaborate and support project resources (CRAs/ CTAs/Centralized Monitoring team).
  • Ensure complete and accurate documentation of all the site-specific tools and templates and keep the sites audit ready.;
  • Perform centralized monitoring activities on assigned sites and evaluate their quality and integrity as per the protocol, SOPs respective regulation and guidelines.
  • Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the Site-specific information.
  • Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).;
  • Perform the activities delegated and/or act as back up for/to relevant stakeholders within the project team.
  • Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan and provide inputs to CMS leads to enable Early identification of site-level risk/issue(s).
  • Monitor site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit).
  • Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed.
  • Work in accordance of the Study Central Monitoring Plan.
  • Establish and maintain effective project/ site level communications with relevant stakeholders.
  • Provide Mentorship to Associate Central Monitors.
  • Reviews reports per annotations, SOPs, guidelines etc., identifies issues and escalates the same to the Clinical Lead, prepares annotations and conducts CRA trainings, conducts monthly calls with relevant stakeholders to discuss major issues emerging from the trends noted during report review.
  • Act as a technical solution specialist (TSS) point of contact to connect with the project teams/internal stake holders for gathering the criteria and requirements.
  • Analyze the complexity of the requirements and provide the EAC hours and turn around time.
  • Review of the Study Central Monitoring Plan
  • Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested
  • Adhere to the key activities outlined in the SOW as per customer requirements.

Qualifications

  • Bachelor's Degree in clinical, life sciences, mathematical sciences, or related field, or nursing qualification.

Requirements

  • Requires minimum of 2 years of relevant work experience or equivalent combination of education, training and experience.
  • Fresher with Medical or Allied medical degree.
  • Experience in clinical research field preferred.
  • Experience level may vary based on customer specific requirements.
  • Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements.
  • i.e. International Conference on Harmonization - Good Clinical Practice (ICH GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.
  • Good Clinical system expertise.
  • Strong written and verbal communication skills including good command of English language.
  • Good command of French Language.
  • Results and detail-oriented approach to work delivery and output.
  • Understanding of clinical/medical data.
  • Good motivational, influencing, coaching skills.
  • Ability to work on multiple projects and manage competing priorities. In depth therapeutic and protocol knowledge.
  • Strong organizational and problem-solving skills.
  • Effective presentation skills.
  • Demonstrated ability to deliver results to the appropriate quality and time line metrics.
  • Ability to work across cultures and geographies with a high awareness and understanding of cultural differences and maintain effective working relationships with co-workers, managers and clients.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more