Clinical Trials Project Manager

Há 1 mês

São Paulo, São Paulo, Brasil Psi CRO Ag Tempo inteiro
Job Description

**About the Role**

We are seeking a highly skilled and experienced Regional Project Lead to join our Clinical Operations team at Psi CRO Ag. As a Regional Project Lead, you will be responsible for managing and coordinating activities of project teams in designated countries and ensuring consistency of Clinical Operations processes across regions.

Key Responsibilities:

  • Develop and implement project plans, ensuring compliance with industry regulations, ICH-GCP, and applicable controlled documents.
  • Act as primary or secondary project management contact for the project team and PSI support services in designated countries.
  • Perform study status review and progress reporting, collecting and reporting project status updates for designated regions.
  • Develop and update project planning documents, essential study documents, and project manuals/instructions.
  • Manage and report on Key Performance Indicators (KPIs) for designated countries and clinical project team members.
  • Ensure project timelines and subject enrollment targets are met in designated countries.
  • Coordinate maintenance of study-specific and corporate tracking systems.
  • Coordinate site contractual startup and budget negotiations.
  • Establish communication lines within the project team and supervise clinical project team members' performance.
  • Identify, escalate, and resolve resourcing and performance issues.
  • Conduct and supervise therapeutic area training of the project team.
  • Prepare presentations and conduct training of Investigators.
  • Ensure team compliance with project-specific training matrix.
  • Perform field training of Monitors tailored to the project needs.
  • Supervise preparation, conduct, and reporting of site selection, site initiation, routine monitoring, and closeout visits.
  • Oversee investigator and site payments, as well as CRF data retrieval/upload and monitoring and the query resolution process.
  • Supervise project team preparation for study audits/inspections and resolution of audit/inspection findings.
  • Coordinate conduct of supervised monitoring visits.
  • Review site visit reports and ensure monitoring and reporting standards are met.
  • Coordinate preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications.
  • Oversee the safety information flow and participate in feasibility research.
  • Review/approve project-related expenses and timesheets.

Requirements:

  • College/University degree in Life Sciences or an equivalent combination of education, training, and experience.
  • At least 4 years of experience in Clinical Research and site monitoring activities.
  • At least 2 years of experience as a Study Manager or Lead with the ability to supervise project activities as a Regional Lead or equivalent.
  • Experience in Oncology is preferred.
  • Full working proficiency in English.
  • Proficiency in MS Office applications, including MS Project.
  • Communication, presentation, and customer-service skills.
  • Ability to negotiate and build relationships at all levels.
  • Team-building, leadership, and organizational skills.

  • Clinical Trial Manager

    Há 5 dias

    São Paulo, São Paulo, Brasil Medpace, Inc. Tempo inteiro

    Regulatory Submissions Manager Job SummaryMedpace, Inc. is seeking a full-time Regulatory Submissions Manager to join our Study Start Up team in Sao Paulo. This role plays a key part in the clinical trial management process, utilizing expertise to develop and grow a career in a dynamic environment.Key Responsibilities:Efficiently manage and successfully...

  • Clinical Trials Manager

    Há 17 horas

    São Paulo, São Paulo, Brasil Amgen Tempo inteiro

    {"**Job Title:** **Local Trial Manager** **Job Summary:** We are seeking a highly skilled and experienced Local Trial Manager to lead and manage the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and other applicable local regulations. **Key Responsibilities:** * Partner with global and local...

  • Clinical Trial Manager

    4 semanas atrás

    São Paulo, São Paulo, Brasil Allucent Tempo inteiro

    Job Title: Senior Clinical Trial LeaderWe are seeking a highly experienced Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and oversight to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial...

  • Clinical Trial Manager

    3 semanas atrás

    São Paulo, São Paulo, Brasil Allucent Tempo inteiro

    Job Title: Senior Clinical Trial LeaderWe are seeking a highly experienced Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and oversight to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial...

  • Clinical Trial Manager

    2 semanas atrás

    São Paulo, São Paulo, Brasil Allucent Tempo inteiro

    Job Title: Senior Clinical Trial LeaderWe are seeking a highly experienced Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and oversight to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial...

  • Clinical Trial Manager

    Há 5 dias

    São Paulo, São Paulo, Brasil Allucent Tempo inteiro

    Job Title: Senior Clinical Trial LeaderWe are seeking a highly experienced Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and oversight to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial...

  • Clinical Trial Manager

    Há 3 dias

    São Paulo, São Paulo, Brasil Allucent Tempo inteiro

    Job Title: Senior Clinical Trial LeaderWe are seeking a highly experienced Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and oversight to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial...

  • Clinical Trials Manager

    Há 1 mês

    São Paulo, São Paulo, Brasil Allucent Tempo inteiro

    Job DescriptionAbout the RoleWe are seeking a highly experienced and skilled Clinical Trials Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other functional groups in their day-to-day clinical trial...

  • Clinical Trials Manager

    Há 4 dias

    São Paulo, São Paulo, Brasil Allucent Tempo inteiro

    Senior Clinical Trial LeaderWe are seeking a highly experienced and skilled Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and oversight to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical...

  • Clinical Project Manager

    Há 17 horas

    São Paulo, São Paulo, Brasil Novasyte Tempo inteiro

    Job Title: Clinical Project ManagerWe are seeking a highly skilled Clinical Project Manager to join our team at Novasyte. As a Clinical Project Manager, you will be responsible for the successful planning, implementation, and execution of clinical trials.Key Responsibilities:Manage projects from start to finish, ensuring timely completion and within...

  • Clinical Trial Manager

    1 semana atrás

    São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

    Job Title: Clinical Trial ManagerAbout the Role:We are seeking a highly skilled Clinical Trial Manager to join our team at IQVIA. As a Clinical Trial Manager, you will be responsible for the local management of clinical trials in a country or countries, ensuring compliance with Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), and local...

  • Clinical Trial Manager

    Há 2 dias

    São Paulo, São Paulo, Brasil Icon Plc Tempo inteiro

    Job Title: Clinical Trial ManagerAt ICON plc, we are seeking a highly skilled Clinical Trial Manager to join our Real World Solutions team. As a Clinical Trial Manager, you will be responsible for the operational oversight of all milestones and activities assigned to projects, including site management and monitoring activities.Key Responsibilities:Develop...

  • Clinical Trials Manager

    Há 1 mês

    São Paulo, São Paulo, Brasil Allucent Tempo inteiro

    Senior Clinical Trial LeaderAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are seeking a Senior Clinical Trial Leader to join our team, responsible for providing leadership, management, and oversight to...

  • Clinical Trial Manager

    1 semana atrás

    São Paulo, São Paulo, Brasil Bancroft School Tempo inteiro

    Job Title: Clinical Trial ManagerMedpace is a leading Contract Research Organization (CRO) that provides clinical development services to the biotechnology, pharmaceutical, and medical device industries. We are seeking an experienced Clinical Trial Manager to join our team in Sao Paulo, Brazil.Responsibilities:Manage and provide accountability for day-to-day...

  • Clinical Trials Manager

    2 semanas atrás

    São Paulo, São Paulo, Brasil Allucent Tempo inteiro

    Senior Clinical Trial LeaderWe are seeking a highly experienced and skilled Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and oversight to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical...

  • Clinical Trials Manager

    Há 1 mês

    São Paulo, São Paulo, Brasil Allucent Tempo inteiro

    Senior Clinical Trial LeaderWe are seeking a highly experienced Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and oversight to our Clinical Research Associates (CRAs) and other functional groups in their day-to-day clinical trial activities.Key...

  • Clinical Trial Manager

    Há 1 mês

    São Paulo, São Paulo, Brasil Bancroft School Tempo inteiro

    {"title": "Clinical Trial Manager", "content": "Key ResponsibilitiesAs a Clinical Trial Manager at Medpace, you will be responsible for managing and providing accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations.You will serve as the primary Sponsor...

  • Clinical Trial Leader

    Há 2 dias

    São Paulo, São Paulo, Brasil Allucent Tempo inteiro

    Job Title: Clinical Trial LeaderAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.Job Summary:We are seeking a highly experienced Clinical Trial Leader to join our team. As a Clinical Trial Leader,...

  • Clinical Project Manager

    Há 11 horas

    São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Job SummaryWe are seeking a highly skilled Clinical Project Manager to join our team at Thermo Fisher Scientific. As a key member of our clinical supplies department, you will play a critical role in ensuring the success of our global clinical trials.Key ResponsibilitiesDevelop Study-Specific Plans: Create and implement study-specific plans for each assigned...

  • Clinical Trial Leader

    42 minutos atrás

    São Paulo, São Paulo, Brasil Allucent Tempo inteiro

    Job Title: Senior Clinical Trial LeaderAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.Job Summary:We are seeking a highly experienced Senior Clinical Trial Leader to join our team. The successful candidate...