- Home /
- Tutti i lavori /
- Bulgaria /
- Centralized Moni...
Bulgaria, SofiaCentralized Monitor- Italian Speaker
Data di pubblicazione 03.04.2025
1 hanno inviato una candidatura
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
Qualifications
Requirements
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 at https://jobs.iqvia.com
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 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.
- 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 coworkers, 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 at https://jobs.iqvia.com
Ci impegniamo ad acquisire informazioni affidabili su ogni lavoro. Segnala se abbiamo sbagliato qualcosa o se hai riscontrato un problema tecnico.
Più posti di lavoro in Bulgaria
Bulgaria, SofiaOrder to Cash Associate (Customer service) with Italian
Bulgaria, VarnaGuest Relations Italian market
Bulgaria, SofiaContracts Negotiator - Italian Speaker
Bulgaria, SofiaAML Analyst with Italian - Sofia, Bulgaria
BulgariaCloud Frontline Support Specialist with Italian
BulgariaItalian VIP Quality Assurance Manager
BulgariaItalian VIP sports book expert
Bulgaria, SofiaBusiness Analyst with Italian (Maternity Leave)
Differenze culturali quando ci si trasferisce all’estero
Trasferirsi all’estero è un'avventura emozionante che apre a nuove opportunità, ma comporta anche delle sfide, soprattutto quando si tratta di differenze culturali. Che tu stia andando all’estero per lavoro, per studio, o semplicemente per un cambiamento, adattarsi a una nuova cultura richiede tempo. Capire queste differenze e abbracciare nuovi modi di vivere è la chiave per una transizione di successo.
8 consigli per superare la nostalgia di casa quando ti trasferisci all'estero
La nostalgia di casa è un sentimento di stress o ansia causato dalla separazione dalle persone e dai luoghi a noi familiari. Quando decidi di trasferirti...
10 favolosi consigli per farti degli amici all'estero se sei introverso
Sentirsi soli dopo un trasferimento all'estero? Ecco 10 consigli pratici per fare amicizia e superare la timidezza!
Evita questi 6 truffe quando cerchi un appartamento all'estero!
Stai per trasferirti all'estero e ora stai cercando un appartamento? Ecco 6 truffe comuni di cui dovresti stare alla larga!
Vivere e lavorare a Madrid
Vivere a Madrid Alloggiare a Madrid Trovare un appartamento a Madrid Prezzi delle abitazioni a Madrid Vivere a Madrid Fare amicizia a Madrid Costo della vita a Madrid Lavorare a Madrid Vivere a Madrid Informazioni...
Vivere e lavorare ad Atene
Vivere e lavorare ad Atene, è una buona scelta per gli expat? In Workwide, diciamo di sì! Continua a leggere per imparare tutto quello che devi sapere sul trasferimento ad Atene.
Incontrate il nuovo Workwide - Un'esperienza digitale per la vostra carriera all'estero.
Siamo felici di annunciare che, dopo mesi di duro lavoro e preparazione, Workwide è ora ancora migliore!
Vivere e lavorare in Irlanda
Quello che si dice in giro è vero: l'Irlanda è bellissima. Quest'isola situata al largo delle coste dell'Inghilterra e del Galles presenta una ricchezza naturale fuori...
Vivere e lavorare a Cipro
L'isola di Cipro, situata nel Mar Mediterraneo sudorientale, offre numerose possibilità sia come destinazione turistica che dal punto di vista delle opportunità di lavoro: grazie alla...
Trova il tuo appartamento in Bulgaria
Appartamenti
€1,000
mese
180giorni
Permanenza min
Appartamenti
€700
mese
Appartamenti
€850
mese
30giorni
Permanenza min
Appartamenti
€872
mese
120giorni
Permanenza min
Appartamenti
€1,300
mese
90giorni
Permanenza min
Locali condivisi
€359
mese
120giorni
Permanenza min
Appartamenti
€495
mese
90giorni
Permanenza min
Appartamenti
€1,000
mese
90giorni
Permanenza min