Local Trial Manager

hace 1 semana

Buenos Aires, Argentina IQVIA A tiempo completo

Local Trial Management services provides local management of a clinical trial (or Medical Affairs data generation activity) in the country. 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), Clinical Research Associate (CRA) and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery at the country level.

**Responsabilities**:

- 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. Collaborates with central study team and local stakeholders as applicable for final selection of sites to participate in trial.
- Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Act as primary company contact for assigned trial at the country level, may attend/participate in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. When necessary, initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams and Quality & Compliance team.
- Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
- Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. As required, manages the local study supply.
- Ensures high standards for study monitoring by conducting quality local trial team meetings and facilitating CRA training, when needed (i.e. implementation of study amendment-and changes in study related processes).
- Contributes to patient understanding of protocol and patient safety by preparing country specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations

**Qualifications**:

- BA/BS degree.
- Degree in a health or science related field.
- 2 years of local trial management or mutually agreed clinical trial experience
- Advanced English

  • Local Trial Manager

    hace 7 meses

    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 6 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Local Trial Manager - Sponsor Dedicated.** Primary point of contact to lead, mange and co-ordinate assigned project(s) at the country level for end-to-end project management from start-up through to closeout activities. **Tasks & Responsibilities**: - Partner with global, local country teams and study team to provide high level country strategy, drive...

  • Local Trial Manager

    hace 7 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    Local Trial Manager – Sponsor Dedicated. Primary point of contact to lead, mange and co-ordinate assigned project(s) at the country level for end-to-end project management from start-up through to closeout activities. Tasks & Responsibilities: • Partner with global, local country teams and study team to provide high level country strategy, drive...

  • Local Trial Manager

    hace 6 meses

    Buenos Aires, Argentina Amgen A tiempo completo

    **Job Description**: **HOW MIGHT YOU DEFY IMAGINATION?** You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...

  • Clinical Trial Manager

    hace 6 meses

    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,...

  • (Senior) Clinical Trial Manager

    hace 7 meses

    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-oncology

    hace 1 mes

    Buenos Aires, Argentina ICON Plc A tiempo completo

    Clinical Trial Manager, Oncology - LATAM / Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Trial...

  • Clinical Trial Manager

    hace 1 mes

    Buenos Aires, Argentina ICON Plc A tiempo completo

    Senior Clinical Trial Manager - Argentina, Buenos Aires ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior...

  • Clinical Trial Project Manager

    hace 4 semanas

    Buenos Aires, Buenos Aires C.F., Argentina IQVIA A tiempo completo

    Job DescriptionWe are seeking an experienced Clinical Trial Project Manager to lead our projects at the country level. As a key member of our team, you will be responsible for managing clinical studies from start-up through to closeout activities.

  • Trial Capabilities Assistant

    hace 7 meses

    Buenos Aires, Argentina Eli Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...

  • Local Trial Manager

    hace 7 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Job Overview Senior Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Senior Project Lead is an essential member of the core project team leading the team and responsible for project delivery of clinical studies to meet contractual...

  • Local Trial Manager

    hace 7 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Job Overview** Senior Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Senior Project Lead is an essential member of the core project team leading the team and responsible for project delivery of clinical studies to meet contractual...

  • Site Manager

    hace 7 meses

    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...

  • Sr. Trial Capabilities

    hace 3 semanas

    Buenos Aires, Argentina Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Senior Site Manager

    hace 6 meses

    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...

  • Trial Capabilities Associate Jr

    hace 8 meses

    Buenos Aires, Argentina Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Clinical Trial Manager

    hace 7 meses

    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,...

  • Trainee - Trial Capabilities

    hace 8 meses

    Buenos Aires, Argentina Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Sr. Associate-trial Capabilities Clinical

    hace 8 meses

    Buenos Aires, Argentina Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Senior Clinical Trial Manager, Oncology, Argentina

    hace 6 meses

    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...