Clinical Trial Manager

hace 1 semana

Buenos Aires, Argentina Bristol Myers Squibb A tiempo completo

En Bristol Myers Squibb, nos inspira una sola visión: transformar la vida de los pacientes a través de la ciencia. En oncología, hematología, inmunología y enfermedades cardiovasculares, y una de las líneas de producción más diversas y prometedoras de la industria, cada uno de nuestros apasionados compañeros contribuye a innovaciones que impulsan cambios significativos. Aportamos un toque humano a cada tratamiento en el que somos pioneros. Únete a nosotros y marca la diferencia.

Key Responsibilities and Major Duties
- Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocolmanager and other global study team members
- Coordinates with other internal roles in country and site feasibility process, including proposal and validation ofcountry study targets
- Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level studyenrolment targets and timelines are met
- Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution andescalation to the appropriate stakeholder/s
- Assessment and set up the of vendors during study start up period (locally)
- Investigator Meeting participation and preparation
- Ensures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendorsystems is available for the Country and clinical trial site personnel
- Validation of study related materials (i.e. protocol, ICF, patient material)
- Responsible for preparing country specific documents (e.g. global country specific amendment)
- Prepares materials for Site Initiation Visits
- Responsible for verifying and confirming with local team eTMF completeness (Country and Site level)
- Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensuresappropriate documentation of issues.
- Coordination of database locks and query follow up. Ensures timelines are met.
- Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities
- Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation forCountry audit level findings. Drives CAPA review, implementation and completion.
- Lead study team meetings locally
- Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable)
- Management of Site relationships (includes CRO related issues)
- May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs)
- May perform site closure activities, including post-close out
- May act as point of contact for Sites
- May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances.

**Requirements**:

- Bachelor's degree required preferably within life sciences or equivalent.
- Minimum of 4 years' industry related experience
- Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
- In depth knowledge and understanding of clinical research processes, regulations and methodology
- Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
- Demonstrated organizational and planning skills and independent decision-making ability
- Strong organization and time management skills and ability to effectively manage multiple competing priorities
- Ability of critical thinking and risk analysis.
- Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels
- Skilled in the use of technology
- Good verbal and written communication skills (both in English and local language).
- Knowledge in Software:

- Microsoft Suite
- Clinical Trial Management Systems(CTMS)
- Electronic Data Capture Systems (eDC)
- Electronic Trial Master File (eTMF)

LI-hybrid

En todo el mundo, nos apasiona tener un impacto en la vida de los pacientes con enfermedades graves. Con el poder de aplicar nuestros talentos individuales y perspectivas diversas en una cultura inclusiva, nuestros valores compartidos de pasión, innovación, urgencia, responsabilidad, inclusión e integridad sacan a relucir el mayor potencial de cada uno de nuestros colegas.

Bristol Myers Squibb reconoce la importancia del equilibrio y la flexibilidad en nuestro entorno de trabajo. Ofrecemos una amplia variedad de beneficios, servicios y programas competitivos que brindan a nuestros empleados los recursos para perseguir sus metas, tanto en el trabajo como en su vida personal.

  • Clinical Trial Manager

    hace 2 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    Clinical Trial Manager – Sponsor Dedicated. Clinical Trial Manager provides for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agree upon...

  • Clinical Trial Manager

    hace 3 semanas

    Buenos Aires, Argentina Icon plc A tiempo completo

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Clinical Trial Manager

    hace 2 semanas

    Buenos Aires, Argentina Icon plc A tiempo completo

    At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...

  • (Senior) Clinical Trial Manager

    hace 4 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    Clinical Trial Manager – Sponsor Dedicated. Clinical Trial Manager provides for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agree upon...

  • Sr. or Clinical Trial Manager Ii, Oncology;

    hace 2 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    IQVIA Biotech is committed and dedicated to the small biotech & biopharma companies we support. Opportunities available for an experienced Clinical Trial Manager II or Senior Clinical Trial Manager. Previous clinical trial management and CRO experience preferred. Therapeutic requirements/preference: any of the following Oncology/Hematology/CAR T/Cell &...

  • Clinical Trial Site Engagement Sr Manager

    hace 3 semanas

    Buenos Aires, Argentina Amgen A tiempo completo

    Career Category Clinical **Job Description**: Clinical Trial Site Engagement Sr Manager Develop, implement and maintain an integrated site engagement and operational role at key/targeted sites in line with Global Development pipeline to support strategic global study strategy plan to accelerate development of marketed products and early pipeline assets....

  • Clinical Trial Site Engagement Sr Manager

    hace 3 semanas

    Buenos Aires, Argentina Amgen A tiempo completo

    Clinical Trial Site Engagement Sr Manager Develop, implement and maintain an integrated site engagement and operational role at key/targeted sites in line with Global Development pipeline to support strategic global study strategy plan to accelerate development of marketed products and early pipeline assets. Maintains an effective collaborative partnership...

  • Sr. or Clinical Trial Manager Ii, Oncology;

    hace 2 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    IQVIA Biotech is committed and dedicated to the small biotech & biopharma companies we support.Opportunities available for an experienced Clinical Trial Manager II or Senior Clinical Trial Manager.Previous clinical trial management and CRO experience preferred.Therapeutic requirements/preference: any of the following Oncology/Hematology/CAR T/Cell & Gene...

  • Clinical Trial Manager

    hace 3 semanas

    Buenos Aires, Argentina ICON plc A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...

  • Clinical Trial Assistant

    hace 4 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Join us as a **Clinical Trials Assistant!**: **What You´ll Do** Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. **Essential Functions** - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up...

  • Senior Clinical Trial Manager, Oncology, Argentina

    hace 4 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    Required: 3+ years of Clinical Trial Management experience (CRO experience preferred). Experience managing clinical trials in LATAM and North America required Oncology experience related to managing studies Fluent in English, both writing and verbally Preferred: Experience managing global studies Experience managing studies in other therapeutic areas...

  • Clinical Trial Assistant

    hace 4 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    Join us as a Clinical Trials Assistant! - What You´ll DoPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with...

  • Clinical Trial Manager

    hace 5 días

    Buenos Aires, Argentina ICON plc A tiempo completo

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Clinical Trial Manager

    hace 4 semanas

    Buenos Aires, Argentina ICON plc A tiempo completo

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Clinical Trial Coordinator

    hace 5 días

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    FSP Clinical Trial Coordinator. Fully remote (2 days of office at GSK)

  • Clinical Trial Manager

    hace 2 semanas

    Buenos Aires, Argentina Bristol Myers Squibb A tiempo completo

    En Bristol Myers Squibb, nos inspira una sola visión: transformar la vida de los pacientes a través de la ciencia. En oncología, hematología, inmunología y enfermedades cardiovasculares, y una de las líneas de producción más diversas y prometedoras de la industria, cada uno de nuestros apasionados compañeros contribuye a innovaciones que impulsan...

  • Local Trial Manager

    hace 2 semanas

    Buenos Aires, Argentina Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...

  • Local Trial Manager

    hace 4 semanas

    Buenos Aires, Argentina Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...

  • Clinical Trial Assistant

    hace 2 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    Join us as a Clinical Trials Assistant What You ́ll DoPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with...

  • Clinical Trial Manager

    hace 2 semanas

    Buenos Aires, Argentina ICON plc A tiempo completo

    At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...