Clinical Trials Regional Project Manager

hace 7 días

Bogotá, Bogotá D.E., Colombia PSI A tiempo completo

Job Summary

We are seeking a highly skilled Clinical Trials Regional Project Manager to join our team at PSI. As a key member of our Clinical Operations department, you will be responsible for coordinating project activities, ensuring milestones are met, and maintaining consistency of Clinical Operations processes across regions.

Key Responsibilities

  1. Coordinate project team work and supervise the performance of clinical project team members.
  2. Implement and manage projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents.
  3. Act as a point of contact for the project team, PSI support services, and contractors.
  4. Collect and report project status updates.
  5. Develop and update project planning documents, essential study documents, and project manuals/instructions.
  6. Conduct and supervise therapeutic area training of the project team and Investigators.
  7. Supervise preparation, conduct, and reporting of site selection, site initiation, routine monitoring, and closeout visits, and review site visit reports.
  8. Oversee investigator and site payments.
  9. Supervise project team preparation for study audits/inspections and resolution of audit/inspection findings.
  10. Coordinate preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications.
  11. Perform other project management tasks in agreement with the responsible Clinical Operations Manager following adequate and documented training and formal delegation of tasks.

Requirements

  1. College/University degree in Life Sciences or an equivalent combination of education, training & experience.
  2. Full working proficiency in Spanish and English.
  3. At least 4 years' experience in a health care or clinical environment.
  4. Minimum 4 years' site monitoring experience and at least 2 years' experience as Lead Monitor or equivalent.
  5. Availability to travel.
  6. Proficiency in MS Office applications.
  7. Ability to plan and work in a dynamic team environment.
  8. Communication, collaboration, and problem-solving skills.

Additional Information

  • Clinical Trials Regional Project Manager

    hace 6 días

    Bogotá, Bogotá D.E., Colombia PSI A tiempo completo

    Job DescriptionJob Summary:We are seeking a highly skilled and experienced Clinical Trials Regional Project Lead to join our team at PSI. As a key member of our Clinical Operations department, you will be responsible for coordinating project activities, ensuring milestones are met, and maintaining consistency of Clinical Operations processes across...

  • Clinical Research Manager

    hace 6 días

    Bogotá, Bogotá D.E., Colombia MSD A tiempo completo

    Job SummaryWe are seeking a highly skilled Clinical Research Manager to join our team at MSD. As a Clinical Research Manager, you will be responsible for the end-to-end performance and project management of assigned protocols in a country, ensuring compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards, and...

  • Clinical Trials Operations Manager

    hace 1 semana

    Bogotá, Bogotá D.E., Colombia IQVIA A tiempo completo

    Job OverviewAs a key member of the IQVIA team, the Centralized Monitoring Lead will provide leadership and guidance to the centralized monitoring team to ensure the successful delivery of clinical trials. This role will work closely with project and clinical leads to achieve project objectives, optimize speed, quality, and cost of delivery, and ensure...

  • Clinical Operations Lead

    hace 7 días

    Bogotá, Bogotá D.E., Colombia Amgen A tiempo completo

    About the RoleWe are seeking a highly skilled Clinical Operations Lead to join our team at Amgen. As a key member of our clinical operations team, you will be responsible for overseeing clinical trials processes and operations, ensuring compliance with regulatory requirements, and driving strategic alignment with local and regional teams.Key...

  • Experienced CRA for Clinical Trials

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo

    Position Overview:The Senior Clinical Research Associate (Sr CRA) plays a pivotal role in overseeing and coordinating all facets of clinical monitoring and site management in compliance with industry standards and regulations.Key Responsibilities:Conduct site evaluations to ensure adherence to protocols and regulatory requirements.Maintain ongoing...

  • Clinical Research Manager

    hace 6 días

    Bogotá, Bogotá D.E., Colombia MSD A tiempo completo

    Job DescriptionThis role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.The CRM could be responsible for a particular...

  • SAS Programmer I

    hace 3 días

    Bogotá, Bogotá D.E., Colombia Psi CRO Ag A tiempo completo

    About the RoleWe are a dynamic and global company that values our staff, clients, partners, and the quality of work we do. As a leading Contract Research Organization (CRO), we bring together over 2,700 driven, dedicated, and passionate individuals who work on the frontline of medical science, changing lives, and bringing new medicines to those who need...

  • Clinical Research Manager

    hace 1 mes

    Bogotá, Bogotá D.E., Colombia MSD A tiempo completo

    Job DescriptionThis role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.The Clinical Research Manager (CRM) could be...

  • Centralized Monitoring Lead

    hace 1 semana

    Bogotá, Bogotá D.E., Colombia IQVIA A tiempo completo

    Job OverviewAs a key member of the IQVIA team, the Centralized Monitoring Lead will provide leadership and guidance to the centralized monitoring team, working in partnership with project and clinical leads to achieve the delivery of project objectives to the sponsor's satisfaction. This role requires a strong focus on leading and advising the centralized...

  • Clinical Trials Operations Coordinator

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo

    Overview: The Clinical Trials Operations Coordinator plays a pivotal role in providing both administrative and technical assistance to the Project Team. This position is essential for maintaining audit readiness by ensuring that documentation is reviewed in accordance with the organization's Standard Operating Procedures (SOP) and departmental...

  • Clinical Development Expert

    hace 2 días

    Bogotá, Bogotá D.E., Colombia BOG Fortrea Colombia Ltda. A tiempo completo

    **About Us**BOG Fortrea Colombia Ltda. is a leading global contract research organization (CRO) with a strong commitment to scientific rigor and a rich history of clinical development expertise. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across...

  • Clinical Lead

    hace 5 días

    Bogotá, Bogotá D.E., Colombia IQVIA A tiempo completo

    About the RoleWe are seeking an experienced Clinical Lead to join our team at IQVIA. As a Clinical Lead, you will be responsible for providing leadership of the clinical team, in support of the project leader, and in collaboration with other functional teams, to achieve the delivery of the project's overall objectives to the Sponsor's satisfaction per...

  • Lead Clinical Monitoring Specialist

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo

    Position Overview:The Senior Clinical Research Associate (Sr CRA) plays a pivotal role in overseeing and coordinating the clinical monitoring and site management processes. This position is essential in ensuring compliance with ICH GCP, FDA regulations, local laws, and internal standard operating procedures.Key Responsibilities:Conducts thorough site visits...

  • Clinical Lead

    hace 7 días

    Bogotá, Bogotá D.E., Colombia IQVIA A tiempo completo

    Job DescriptionJob Title: Clinical Lead - Project ManagementJob Summary:We are seeking an experienced Clinical Lead to join our team at IQVIA. The successful candidate will provide leadership of the clinical team, in support of the project leader, and in collaboration with other functional teams, to achieve the delivery of the project's overall objectives to...

  • Clinical Trial Coordinator FSP LATAM

    hace 7 días

    Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Trial Coordinator to join our team at Thermo Fisher Scientific. As a Clinical Trial Coordinator, you will play a critical role in the success of our clinical trials by providing administrative and technical support to our project teams.Key ResponsibilitiesAdministrative Support:...

  • Clinical Research Project Coordinator LATAM

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo

    Overview: The Clinical Trial Coordinator plays a pivotal role in providing both administrative and technical assistance to the Project Team. This position is crucial for maintaining audit readiness by ensuring that documentation is reviewed in accordance with the organization's Standard Operating Procedures (SOP) and departmental guidelines. The...

  • Clinical Data Science Program Manager

    hace 7 días

    Bogotá, Bogotá D.E., Colombia ICON A tiempo completo

    About the RoleWe are seeking a highly skilled Clinical Data Science Program Manager to join our team at ICON. As a key member of our Full Service IOD Clinical Data Science team, you will be responsible for ensuring program and study level goals and objectives are consistently met to the highest standard of quality.Key ResponsibilitiesProgram Management:...

  • Senior Clinical Trial Coordinator

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia CDS Fortrea Inc. A tiempo completo

    As a prominent global contract research organization (CRO) dedicated to scientific excellence and extensive clinical development expertise, CDS Fortrea Inc. offers pharmaceutical, biotechnology, and medical device clients a comprehensive array of clinical development, patient access, and technological solutions across over 20 therapeutic areas. With a...

  • Senior Clinical Trial Coordinator

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia CDS Fortrea Inc. A tiempo completo

    As a prominent global contract research organization (CRO) dedicated to scientific excellence and equipped with extensive clinical development expertise, CDS Fortrea Inc. offers pharmaceutical, biotechnology, and medical device clients a comprehensive array of clinical development, patient access, and technological solutions across more than 20 therapeutic...

  • Clinical Trial Operations Specialist

    hace 5 días

    Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Trial Coordinator II to join our team at Thermo Fisher Scientific. As a Clinical Trial Coordinator II, you will play a critical role in supporting the project team by providing administrative and technical support.Key ResponsibilitiesAdministrative Support: Provide administrative...