Empregos atuais relacionados a Clinical Trial Operations Manager - São Paulo, São Paulo - Allucent

  • Senior Clinical Research Associate

    3 semanas atrás

    São Paulo, São Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro

    Principal Clinical Research AssociateJob SummaryCTI Clinical Trial Services, Inc. is seeking a highly skilled and experienced Principal Clinical Research Associate to join our team. As a key member of our clinical operations team, you will be responsible for overseeing the management of clinical trials, ensuring compliance with regulatory requirements, and...

  • Clinical Trial Operations Manager

    3 semanas atrás

    São Paulo, São Paulo, Brasil Bancroft School Tempo inteiro

    Lead Clinical Trial OperationsLogin to a dynamic and growing team of professionals at Medpace, a leading Contract Research Organization (CRO) providing clinical development services to the biotechnology, pharmaceutical, and medical device industries.We are seeking a highly skilled Clinical Trial Operations Manager to join our Sao Paulo, Brazil team. As a key...

  • Global Clinical Trials Manager

    2 semanas atrás

    São Paulo, São Paulo, Brasil Allucent Tempo inteiro

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

  • Clinical Trials Manager

    Há 1 mês

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

    Key Responsibilities:As a Regulatory Submissions Manager at Medpace, you will play a vital role in the clinical trial management process. Your primary focus will be on efficiently managing and successfully completing regulatory submissions for our LATAM clinical trials.Key Skills and Qualifications:• Strong expertise in clinical trial management and...

  • Clinical Operations Manager

    1 semana atrás

    São Paulo, São Paulo, Brasil CDS Fortrea Inc. Tempo inteiro

    Clinical Operations Manager Job DescriptionCompany Overview: As a leading global contract research organization (CRO), CDS Fortrea Inc. has a passion for scientific rigor and decades of clinical development experience, providing pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and...

  • Senior Clinical Research Manager

    3 semanas atrás

    São Paulo, São Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro

    Clinical Research Excellence at CTI Clinical Trial Services, IncWe maintain a culture of excellence across all regions by ensuring our remote employees are fully engaged. To achieve this, we hold weekly all-staff meetings. Each department provides an update on their study or milestone progress. Additionally, our employees can participate in one of our CTI...

  • Clinical Operations Manager

    Há 1 mês

    São Paulo, São Paulo, Brasil Msd Tempo inteiro

    This role is accountable for performance and compliance for assigned protocols in a country in accordance with regulations, policies, quality standards, and adverse event reporting requirements.The person is responsible for budget/finance aspects, execution, and oversight of clinical trial country submissions and approvals, and ensuring Site...

  • Clinical Trial Operations Specialist

    3 semanas atrás

    São Paulo, São Paulo, Brasil Iqvia Tempo inteiro

    Job SummaryWe are seeking a skilled Clinical Trial Operations Specialist to join our team at Iqvia.About the RoleThe successful candidate will be responsible for the local management of clinical trials, ensuring compliance with Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), and local regulatory requirements.Key ResponsibilitiesPrepare...

  • Senior Clinical Trial Management Specialist

    4 semanas atrás

    São Paulo, São Paulo, Brasil Beigene Tempo inteiro

    Job Summary:We are seeking a highly skilled and experienced Clinical Trial Management Associate to join our team in a Senior Regional Clinical Trial Management Associate role.About the Role:As a Senior Regional Clinical Trial Management Associate, you will be responsible for supporting the Regional Clinical Study Manager in regional study delivery and...

  • Clinical Trial Manager Leadership Position

    2 semanas atrás

    São Paulo, São Paulo, Brasil ICON Plc Tempo inteiro

    Overview of ICON PlcICON Plc is a leading healthcare intelligence and clinical research organization dedicated to shaping the future of clinical development.Salary InformationWe are offering a competitive annual salary of approximately $110,000 - $140,000 based on experience.Job ResponsibilitiesAs a Senior Clinical Trial Manager at ICON Plc, you will be...

  • Clinical Operations Manager

    Há 1 mês

    São Paulo, São Paulo, Brasil Msd Tempo inteiro

    This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...

  • Regional Clinical Trial Operations Specialist

    2 semanas atrás

    São Paulo, São Paulo, Brasil Beigene Tempo inteiro

    About BeiGeneBeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals in the biotech industry.Salary Information:The estimated salary range for this position is $80,000 - $110,000 per year, depending on experience.Job DescriptionWe are seeking a skilled Regional Clinical Trial Operations Specialist...

  • Clinical Operations Manager for Therapeutic Solutions

    2 semanas atrás

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

    About the RoleWe are seeking an experienced Clinical Operations Manager to lead our therapeutic solutions team. As a key member of our Project Delivery team, you will be responsible for directing, coordinating, and managing the technical and operational aspects of projects.ResponsibilitiesDevelop and implement clinical tools, such as Monitoring Plans and...

  • Clinical Trial Educator

    3 semanas atrás

    São Paulo, São Paulo, Brasil Novasyte Tempo inteiro

    **Job Overview**The Clinical Trial Educator, based in our global network, will collaborate with trial coordinators and healthcare providers to provide information and education on clinical trial inclusion and exclusion criteria.This role requires working in partnership with CRAs and other field-based medical teams to develop tailored recruitment plans and...

  • Clinical Trial Coordinator

    2 semanas atrás

    São Paulo, São Paulo, Brasil Icon Plc Tempo inteiro

    **About ICON Plc**We are a world-leading healthcare intelligence and clinical research organization.Our mission is to shape the future of clinical development, and we welcome you to be a part of it.We are currently seeking a Clinical Trial Administrator to join our diverse and dynamic team.As a Clinical Trial Administrator at ICON, you will play a pivotal...

  • Clinical Trial Coordinator

    1 semana atrás

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

    Unlock a Career in Clinical ResearchWe are seeking a skilled and dedicated Clinical Trial Coordinator to join our team at Thermo Fisher Scientific. As a Clinical Trial Coordinator, you will play a crucial role in the success of our clinical trials, working closely with our clients to ensure timely and efficient project delivery.About the RoleThis is a...

  • Clinical Supply Operations Manager

    3 semanas atrás

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

    About the Role: This position supports clinical supply operations for global clinical trials, ensuring project activities comply with company and client requirements. As a representative and project lead, the successful candidate will coordinate efforts, provide recommendations and risks, and update project reports. Key Responsibilities:Develops...

  • Clinical Trials Manager

    2 semanas atrás

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

    **About Medpace, Inc.**We are a global full-service clinical research organization (CRO) providing a complete range of services to support the development and approval of pharmaceuticals, biotechnology, and medical device products.**Our LATAM Clinical Trial Activities**We have been growing rapidly in recent years, and as part of our efforts to continue this...

  • Senior Clinical Trials Coordinator

    2 semanas atrás

    São Paulo, São Paulo, Brasil Icon Plc Tempo inteiro

    Company OverviewICON plc is a global healthcare intelligence and clinical research organization dedicated to fostering innovation and excellence. Our diverse and dynamic team is committed to shaping the future of clinical development.SalaryWe offer a competitive salary of $65,000 - $85,000 per annum, commensurate with experience, in addition to a range of...

  • Clinical Trial Coordinator

    4 semanas atrás

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

    Key ResponsibilitiesSupports the Project Team in providing administrative and technical assistance for clinical trials. Ensures audit readiness by reviewing files according to the organization's SOP and department guidance document. Provides administrative support for site activation activities, including developing the critical path for site activation...

Clinical Trial Operations Manager

Há 1 mês

São Paulo, São Paulo, Brasil Allucent Tempo inteiro

Job Summary

We are seeking a highly skilled Clinical Trial Operations 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 clinical functional groups. Your primary focus will be on ensuring the successful planning, implementation, and execution of clinical trials.

Key Responsibilities

  • Coordinating and managing CRA activities across all geographies, liaising with sponsors and project managers to ensure clinical monitoring deliverables are met.
  • Oversight of critical documentation collection, maintenance, and filing.
  • Developing monitoring plans and site monitoring templates, as well as providing input into trial plans and tools.
  • Reviewing trial-specific documents and developing or reviewing subject-facing materials.
  • Customizing annotated site visit reports according to trial-specific requirements.
  • Selection of investigators and sites, SEV report review, and approval.
  • Site initiation management, SIV report review, and approval.
  • Monitoring visit report review, management, resolution, and escalation.
  • Managing successful trial close-out, identifying critical activities to ensure timely and efficient close-out.
  • Responsible for timelines, budget, and quality of clinical monitoring team deliverables, identification of risks, and issues, and escalation to project managers, line managers, and GCO management.
  • Providing information and input about planned activities and status to project managers and attending project review meetings as needed.
  • Conducting project co-monitoring and temporarily conducting site management/monitoring in case of immediate need and lack of resources.
  • Coaching and mentoring CRA team members, including providing performance feedback, assisting in developing and delivering project-specific training, and providing input related to project-specific training matrices.
  • Preparing and chairing CRA calls and actively participating in internal trial team calls and client calls.
  • Overseeing CRA handovers as appropriate.
  • Serving as a site contact for protocol clarifications and subject enrollment when CRAs are unavailable.
  • Monitoring and managing trial materials supplies, ensuring investigational products and other trial supplies are shipped to sites.
  • Reviewing data listings and query reports to identify trends and ensuring proactive re-training is conducted with CRAs and site staff.
  • Overseeing the process of protocol deviation and trial non-compliance documentation, tracking, and escalation.
  • Participating in the development of trial newsletters and communication.
  • Requesting appropriate clinical operations staffing, workload, and resources and reporting trial deliverables and resource needs.
  • Assisting project managers in discussions with clients on trial documentation issues or technical-related documentation concerns that may arise.
  • Reviewing trial systems (CTMS, CRF, IRS, central lab portal, etc.) updates on a regular basis, ensuring systems reports are up to date, and reports generated are current and correct.
  • Overseeing eTMF status.
  • Reviewing trial reports and analyzing trends to recognize risks, providing input into mitigation plans, and implementing mitigations belonging to clinical activities.
  • Contributing to the optimization of trial processes to increase efficiency.
  • Coordinating and providing support for trial-related (site) audits and inspections.
  • Contributing to corrective and preventive action plans where needed and ensuring their timely implementation and closure.
  • Ensuring project consistency within and across projects by following Allucent/relevant SOPs.
  • Assisting and supporting in the preparation of various training materials used by Allucent (including SOPs training, as well as specific trial-related training).
  • Assisting in the preparation and conduct of Kick-Off Meetings, Investigators' meetings, and other committees or trial meetings as requested.
  • Preparing country-level site-facing budgets and managing investigator and site payments as applicable.
  • Supporting project managers in the management of trial vendors as required.
  • Project contract awareness and oversight.
  • Forecasting and reporting on site management units throughout the project life cycle.
  • Identifying changes in scope and liaising with project managers.
  • Managing client expectations related to clinical deliverables in accordance with contracted services and Allucent QMS.
  • Providing input into proposals when required.
  • Actively participating in the preparation, attendance, and presentation of bid defenses or any other presentations to potential clients.
  • Completing routine administrative tasks in a timely manner (timesheets, travel expense claims, training).

Requirements

  • Candidate must be legally authorized to work in the specified country where the job is being advertised.
  • A degree in life sciences or nursing qualification preferred, but not required.
  • A minimum of 5 years of clinical research experience (including a combination of SCRA + CTL/CTM, PM, or regulatory/auditing experience) with at least 2 years of CTL/CTM experience.
  • In-depth knowledge of ICH GCP, clinical trials, and the critical elements for success in clinical trials.
  • Strong therapeutic background.
  • Possesses experience and knowledge in the CRO industry that will support Allucent's management of clinical trials.
  • Strong written and verbal communication skills, including good command of the English language.
  • Professional and strong client-focused.
  • Ability to work in a fast-paced, challenging environment of a growing company.
  • Administrative excellence with attention to detail and accuracy.
  • Leadership and mentoring skills with the ability to mentor and train other CRAs in a positive and effective manner.
  • Excellent team player with team-building skills.
  • Strong organizational skills to be able to manage a full workload across multiple projects.
  • Demonstrates flexibility for creating solutions and process improvement.
  • Analytical, financial, and problem-resolution skills.
  • Proficiency with various computer applications, such as Word, Excel, and PowerPoint, CTMS, eTMF required.
  • Ability to successfully manage people/project issues.
  • Mature management skills demonstrated by calm and thorough review of situations.
  • Proposes, implements, and evaluates appropriate, creative resolutions.
  • Demonstrates the ability to define and meet project requirements.

Benefits

Benefits of working at Allucent include:

  • Comprehensive benefits package per location.
  • Competitive salaries per location.
  • Departmental study/training budget for furthering professional development.
  • Flexible working hours (within reason).
  • Opportunity for remote/hybrid working depending on location.
  • Leadership and mentoring opportunities.
  • Participation in our Buddy Program as a new or existing employee.
  • Internal growth opportunities and career progression.
  • Financially rewarding internal employee referral program.
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms.