Clinical Trial Leader

Há 3 horas

São Paulo, São Paulo, Brasil Allucent Tempo inteiro
Job Title: Senior Clinical Trial Leader

At 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 will provide leadership, management, and oversight to Clinical Research Associates (CRAs) and other clinical functional groups, ensuring the successful execution of clinical trials.

Key Responsibilities:
  • Coordinate and manage 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.
  • Develop and implement monitoring plans and site monitoring templates and tools.
  • Review trial-specific documents and develop subject-facing materials.
  • Customize 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 (MVR) review, management, resolution, and escalation.
  • Manage 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.
  • Provide information and input about planned activities and status to project managers and attend project review meetings.
  • Conduct project co-monitoring and temporarily conduct site management/monitoring in case of immediate need and lack of resources.
  • Coach and mentor CRA teams, providing performance feedback, developing project-specific training, and inputting into the Project Specific Training Matrix.
  • Prepare and chair CRA calls and actively participate in internal trial team calls and client calls.
  • Oversee CRA handovers and serve as a site contact for protocol clarifications and subject enrollment.
  • Monitor and manage trial materials supplies, ensuring Investigational Product and other trial supplies are shipped to sites.
  • Review data listings and query reports to identify trends and ensure proactive re-training is conducted with CRAs and site staff.
  • Oversee the process of protocol deviation and trial non-compliance documentation, tracking, and escalation.
  • Participate in the development of trial newsletters and communication.
  • Request appropriate Clinical Operations staffing, workload, and resources and report trial deliverables and resource needs.
  • Assist project managers in discussions with clients on trial documentation issues or technical-related documentation concerns.
  • Review trial systems updates, ensure systems reports are up-to-date, and reports generated are current and correct.
  • Oversee eTMF status.
  • Review trial reports and analyze trends to recognize risks, provide input into mitigation plans, and implement mitigations belonging to clinical activities.
  • Contribute to the optimization of trial processes to increase efficiency.
  • Coordinate and provide support for trial-related audits and inspections.
  • Contribute to corrective and preventive action plans where needed and ensure timely implementation and closure.
  • Ensure project consistency within and across projects by following Allucent SOPs.
  • Assist in the preparation of various training materials used by Allucent, including SOPs training and specific trial-related training.
  • Assist in the preparation and conduct of Kick-Off Meetings, Investigators' meetings, and other committees or trial meetings as requested.
  • Prepare Country-Level Site Facing Budgets and manage Investigator and Site Payments as applicable.
  • Support project managers in the management of trial vendors as required.
  • Project contract awareness and oversight, including forecasting and reporting on site management units throughout the project lifecycle.
  • Manage client expectations related to clinical deliverables in accordance with contracted services and Allucent QMS.
  • Provide input into proposals when required.
  • Actively participate in the preparation, attendance, and presentation of bid defenses or any other presentations to potential clients.
  • Complete routine administrative tasks in a timely manner, including timesheets, travel expense claims, and 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 is preferred but not required.
  • A minimum of 5 years of clinical research experience, including a combination of SCRA and 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 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, including Word, Excel, and PowerPoint, CTMS, and eTMF.
  • 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:
  • 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.

  • 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 Trial Leader

    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 management to our Clinical Research Associates (CRAs) and other functional groups in their day-to-day clinical trial...

  • 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 Research Associate Leader

    2 semanas atrás

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

    Principal Clinical Research AssociateWe are seeking a highly skilled Principal Clinical Research Associate to join our team at CTI Clinical Trial Services, Inc. As a key member of our organization, you will play a crucial role in maintaining our company culture across all regions, particularly with our remote employees.Our company values open communication...

  • Clinical Research Associate Lead

    Há 3 horas

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

    Job SummaryWe are seeking a highly experienced Principal Clinical Research Associate to join our team at CTI Clinical Trial Services, Inc. As a key member of our site management team, you will be responsible for ensuring the successful execution of clinical trials at assigned study sites.Key ResponsibilitiesServe as the primary point of contact for assigned...

  • 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 Trial Specialist

    Há 6 dias

    São Paulo, São Paulo, Brasil Tata Consultancy Services Tempo inteiro

    Transform Your Career with Tata Consultancy ServicesAre you looking for a challenging and rewarding career in the life sciences industry? Do you want to work for a company that values innovation, collaboration, and continuous learning? Look no further than Tata Consultancy Services (TCS).About the RoleWe are seeking a highly motivated and detail-oriented...

  • 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 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 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 Trial Coordinator

    1 semana atrás

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

    About the RoleWe are seeking a highly skilled 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, working closely with cross-functional teams to ensure timely and efficient execution.Key ResponsibilitiesProvide administrative and...

  • 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 Trials Manager

    Há 19 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

    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 Trial Manager

    4 semanas atrás

    São Paulo, São Paulo, Brasil ICON plc Tempo inteiro

    {"h1": "Clinical Trial Manager Opportunity at ICON plc", "p": "We are seeking a skilled Clinical Trial Manager to oversee the planning, execution, and successful completion of clinical trials at ICON plc. As a leader in our research department, you will collaborate with cross-functional teams, manage site relationships, and provide strategic guidance to...

  • 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...