Local Clinical Trial Manager

hace 5 días


España IQVIA LLC A tiempo completo

Local Clinical Trial Manager - Sponsor Dedicated
Apply locations: Madrid, Spain
Time type: Full time
Posted on: Posted 2 Days Ago
Job requisition id: R1441865
Services Overview:
Local Trial Management services provide local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities. Further, services will ensure the local trial team is delivering quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Site Manager (SM), and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery at the country level.
Deliverables:

Services rendered will adhere to applicable sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
Complies with relevant training requirements.
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report.
Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget.
Act as primary company contact for assigned trial at the country level, may attend/participate in Investigator Meetings as needed.
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress.
Contribute to site level recruitment strategy and contingency planning.
Delivers competent vendor management at the country level to support the study.
Ensures high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training, when needed.
Contributes to patient understanding of protocol and patient safety by preparing country specific informed consent.
Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines.
Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management.
Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.
With focus on quality and compliance, will work closely with SM to ensure CAPA is implemented for audits/inspections.
Ensure accurate finance reporting and trial delivered within budget.
Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals.
May contribute as a trainer of systems/processes or provide input to functional area in process initiatives.
Full utilization by timely and accurate time reporting.
Experience in management and startup of complex Late Development trials.
Advanced: Autonomy with execution of local trial management services; Depth of knowledge with local trial management services; Process leadership.

Qualifications:

Bachelor's Degree Life sciences or related field Req
2 years of local trial management or mutually agreed clinical trial experience.
Advanced: 3 to 5+ years of trial management experience.
Strong experience in Oncology studies.
Spanish speaker with advanced English level.
Knowledge of clinical trials and skill in applying applicable clinical research regulatory requirements.
Strong written and verbal communication skills.
Strong problem-solving skills.
Ability to work through others to deliver results.
Planning, time management, and prioritization skills.
Attention to detail and accuracy in work.
Good software and computer skills, including MS Office applications.
Ability to establish and maintain effective working relationships.
Good understanding of project financials.
Ability to demonstrate all IQVIA competencies.
Based: Madrid

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
#J-18808-Ljbffr


  • Clinical Trial Manager

    hace 5 días


    España Oncomatryx Biopharma A tiempo completo

    Clinical Trial ManagerOncomatryx Biopharma | Derio, España¿Te apasiona liderar ensayos clínicos innovadores y marcar una diferencia en la lucha contra el cáncer? En Oncomatryx Biopharma, buscamos un Clinical Trial Manager para unirse a nuestro equipo en Derio (Vizcaya) y gestionar ensayos clínicos en oncología en fases precoces con moléculas...

  • Clinical Trial Assistant

    hace 31 minutos


    España Exeltis A tiempo completo

    We are you?Exeltis is a leader in the field of Women's Health. It researches, innovates and creates new treatments and devices to improve the health and wellbeing of women all over the world. With a global footprint spanning more than 40 countries, Exeltis has a team of over 4,000 professionals and a global manufacturing network. Exeltis has one overarching...

  • Clinical Trial Assistant

    hace 46 minutos


    España Exeltis A tiempo completo

    We are you?Exeltis is a leader in the field of Women's Health. It researches, innovates and creates new treatments and devices to improve the health and wellbeing of women all over the world. With a global footprint spanning more than 40 countries, Exeltis has a team of over 4,000 professionals and a global manufacturing network. Exeltis has one overarching...

  • Clinical Trial Assistant

    hace 29 minutos


    España Exeltis A tiempo completo

    We are you? Exeltis is a leader in the field of Women's Health . It researches, innovates and creates new treatments and devices to improve the health and wellbeing of women all over the world. With a global footprint spanning more than 40 countries, Exeltis has a team of over 4,000 professionals and a global manufacturing network. Exeltis has one...


  • España buscojobs España A tiempo completo

    Z483 | Associate Clinical Trial Manager (Phd) - Infectious Disease / Neuroscience / OpthalmologyMadridEUR 50.000 - 70.000Job Summary: Medpace is currently seeking candidates with PhDs and/or Post-Doctoral Research experience for a full-time, office-based Associate Clinical Trial Manager (aCTM) to join our Clinical Trial Management team. The aCTM will work...

  • Clinical Trial Manager

    hace 5 días


    España Medpace A tiempo completo

    Medpace is the leading CRO for Biotech companies and is continuing to add Clinical Trial Managers of different experience levels to join our Clinical Trial Management Group in Spain, particularly in our Madrid office. Clinical Trial Managers with expertise in Neuroscience and CNS are welcome to continue to work in their area of expertise or to expand to a...


  • España Grupo Temporing A tiempo completo

    Importante multinacional farmacéutica ubicada en Sant Joan Despí, precisa un/a CTA (Clinical Trial Assistant). Sus responsabilidades serán: - Preparar y/o coordinar la organización de materiales del estudio. - Organización, mantenimiento, conciliación y archivo en papel y Trial Master Files (eTMF) y asistencia en actividades de apoyo administrativo de...


  • España buscojobs España A tiempo completo

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...


  • España Oxon Epidemiology A tiempo completo

    OXON is seeking a proactive Clinical Trial Assistant (CTA) to join our team in Madrid. Prior experience as a CTA in either a pharmaceutical company or a CRO environment is essential, along with fluency in English. To apply, please send both a CV and a cover letter in English to ****** quoting reference: 'CTA-Spain'. Interviews with shortlisted candidates...


  • España Oxon Epidemiology A tiempo completo

    OXON is seeking a proactive Clinical Trial Assistant (CTA) to join our team in Madrid. Prior experience as a CTA in either a pharmaceutical company or a CRO environment is essential, along with fluency in English. To apply, please send both a CV and a cover letter in English to hroxonepi.com quoting reference: 'CTA-Spain' Interviews with shortlisted...

  • Clinical Manager

    hace 10 horas


    España Hobson Prior A tiempo completo

    Hobson Prior is seeking a Clinical Manager to oversee and coordinate clinical trials. The successful candidate will focus on managing timelines, budgets, and resources while leading a team to ensure successful trial execution. This role can only be based in Italy, Spain, Germany or Netherlands. Please note that to be considered for this role you must have...


  • España Julius Clinical A tiempo completo

    ¿Eres un CRA con experiencia y buscas un nuevo reto? ¡Nos gustaría ponernos en contacto contigo Do you like to coordinate and monitor (inter)national, multicentre clinical trials in order to assure the quality of the clinical data? Then this could be the opportunity to develop your career at our Scientific CRO. We are actively looking for a talented and...


  • España Julius Clinical A tiempo completo

    ¿Eres un CRA con experiencia y buscas un nuevo reto? ¡Nos gustaría ponernos en contacto contigo Do you like to coordinate and monitor (inter)national, multicentre clinical trials in order to assure the quality of the clinical data? Then this could be the opportunity to develop your career at our Scientific CRO. We are actively looking for a talented and...


  • españa Julius Clinical A tiempo completo

    ¿Eres un CRA con experiencia y buscas un nuevo reto? ¡Nos gustaría ponernos en contacto contigo !Do you like to coordinate and monitor (inter)national, multicentre clinical trials in order to assure the quality of the clinical data? Then this could be the opportunity to develop your career at our Scientific CRO.We are actively looking for a talented and...


  • españa Julius Clinical A tiempo completo

    ¿Eres un CRA con experiencia y buscas un nuevo reto? ¡Nos gustaría ponernos en contacto contigo !Do you like to coordinate and monitor (inter)national, multicentre clinical trials in order to assure the quality of the clinical data? Then this could be the opportunity to develop your career at our Scientific CRO.We are actively looking for a talented and...


  • España Empresa Anônima A tiempo completo

    Are you a driven professional with a strong background in clinical trial management and a passion for advancing biotech innovation? Join our fast-growing startup and take a pivotal role in shaping the future of precision medicine. We offer a unique opportunity to lead impactful projects within a dynamic and collaborative environment, with ample room for...

  • Clinical Research Manager

    hace 2 minutos


    España Jordan martorell s.l. A tiempo completo

    Clinical Research ManagerBarcelonaBarcelona, Catalonia, ESAre you a driven professional with a strong background in clinical trial management and a passion for advancing biotech innovation? Join our fast-growing startup and take a pivotal role in shaping the future of precision medicine. We offer a unique opportunity to lead impactful projects within a...


  • España Empresa Anônima A tiempo completo

    Are you a driven professional with a strong background in clinical trial management and a passion for advancing biotech innovation? Join our fast-growing startup and take a pivotal role in shaping the future of precision medicine. We offer a unique opportunity to lead impactful projects within a dynamic and collaborative environment, with ample room for...


  • España buscojobs España A tiempo completo

    Clinical Trial Assistant (Cta) - Office Based | K-294MadridEUR 50.000 - 70.000TFS HealthScience is excited to be expanding our Strategic Resourcing Solutions team and we are looking for an experienced, highly motivated Clinical Trial Assistant (CTA) who shares our vision of providing clinical research excellence. Our Strategic Resourcing Solutions team is a...


  • España United Biosource Corporation A tiempo completo

    UBC are currently recruiting within our clinical leadership team, we are looking to recruit a Lead CRA within the EU. UBC are a leading provider of pharmaceutical support services, partnering with life science companies to demonstrate value, ensure safe use and accelerate patient access to innovative medical products. Our services range from supporting the...