Clinical Trial Manager

Há 3 dias

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

We 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 activities.

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 and tools, 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 make 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/mentoring CRA team, including providing performance feedback, assisting in developing and delivering project-specific training, and providing input related to project-specific training matrix.
  • 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 if CRA unavailable.
  • Monitoring and managing trial materials supplies, ensuring Investigational Product 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 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 material used by Allucent (including SOPs training, as well as specific trial-related).
  • 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:

We offer a comprehensive benefits package, competitive salaries, departmental study/training budget for furthering professional development, flexible working hours, 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, and access to online soft-skills and technical training via GoodHabitz and internal platforms.

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