Clinical Trial Coord

3 semanas atrás

Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

According to the specific role (Central or Local), coordinates, oversees and
completes functions on assigned trial(s) activities as detailed on the task matrix.
Performs department, Internal, Country and Investigator file reviews as
assigned, and documents findings in appropriate system(s).
Ensures allocated tasks are performed on time, within budget and to a highquality standard. Proactively communicates any risks to project leads.
Provides system support (i.e., Activate & eTMF) and ensures system databases
are always current.
Performs administrative tasks on assigned trials, including, but not limited to,
timely processing of documents sent to Client (e)TMF as assigned, performing
(e)TMF reviews, distributing mass mailings and communications as needed,
providing documents and reports to internal team members.
Analyzes and reconciles study metrics and findings reports. Assists with
clarification and resolution of findings related to site documentation.
Assists with coordination, compilation and distribution of Investigator Site File
(ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Assists with study-specific translation materials and translation QC upon request.
Maintains knowledge of and understands SOPs, client SOPs/directives, and
current regulatory guidelines as applicable to services provided.
Where applicable, conducts on-site feasibility visits (Asia Pac only).
May support scheduling of client and/or internal meetings.
May review and track of local regulatory documents.
May provide system support (i.e., Activate & eTMF). May support RBM activities.
May support the maintenance of study specific documentation and systems,
including, but not limited to, study team lists, tracking of project specific training
requirements, system access management and tracking of project level activity
plans in appropriate system(s).
Transmits documents to client and centralized IRB/IEC.
Maintains vendor trackers.
Supports start-up team in Regulatory submissions.
Works directly with sites to obtain documents related to site selection.

Assists the project team with the preparation of regulatory compliance review
packages.
Provides support as needed to coordinate with internal departments, ensuring
site start-tup activities within the site activation critical path are aligned.
May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of
associated documents from investigators and site personnel.
Documents in real time all communication, attempts an follow up associated
with site contact and survey responses.
Supports the review of survey data to ensure responses are logical, complete
and reflective of the question asked.
Works in collaboration with teammates to achieve targeted deadlines for
assigned projects. Communicate with the team and appropriate clinical personnel
regarding site issues and risks.
Ensures an efficient, effective plan is in place for site contact and follow up.
Ensure compliance with the plan and escalate concerns/non-compliance to
management.
May act as the local expert regarding site capacity and experience. Work with
key local personnel to gather knowledge base and recommend additional sites.
Harness this knowledge base when performing local tiering of sites.
Liaises with Global Investigator Services to resolve investigator queries in real
time and maintain ‘accounts and contact’ information.
Contributes to the development and roll-out of global strategic feasibility
processes and best practices.
Trains new personnel in processes and systems.
Utilizes local knowledge to contribute to the identification and development of
new sites.

  • Clinical Trial Site Engagement Sr Manager

    4 semanas atrás

    Sao Paulo, Brasil Amgen Tempo inteiro

    Clinical Trial Site Engagement Sr Manager Develop, implement and maintain an integrated site engagement and operational role at key/targeted sites in line with Global Development pipeline to support strategic global study strategy plan to accelerate development of marketed products and early pipeline assets. Maintains an effective collaborative partnership...

  • Clinical Trials Assistant 1

    Há 15 horas

    São Paulo, Brasil IQVIA Tempo inteiro

    Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions • Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining...

  • Senior Clinical Trial Administrator

    Há 6 dias

    Sao Paulo, Brasil PSI CRO Tempo inteiro

    Company Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. **Job Description**: Join our international team and be the...

  • Clinical Trial Manager

    3 semanas atrás

    São Paulo, Brasil IQVIA Tempo inteiro

    Clinical Trial Manager The Clinical Trial Manager provides leadership of the clinical team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project’s overall objectives to the Sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in...

  • Clinical Trial Management Associate Manager

    4 semanas atrás

    São Paulo, Brasil BeiGene Tempo inteiro

    BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR...

  • Clinical Trial Administrator II

    3 semanas atrás

    São Paulo, Brasil PSI CRO Tempo inteiro

    Job DescriptionJoin our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information. Only CVs in English will be accepted.You will be responsible for:Customization of Site ICF/patient documents before sending it to sites;EC- IRB submissions;Site Room, Veeva...

  • Director/senior Director

    1 semana atrás

    Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Oversees daily operational excellence for area of responsibility and/or assigned projects. Mentors and supports Associate Directors, Directors and other members of their project teams. Collaborates cross functionally with other departments to meet overall business objectives and provide strategic input to new services. Provides global strategic direction,...

  • Clinical Trial Administrator II.

    3 semanas atrás

    São Paulo, Brasil PSI Tempo inteiro

    Job Description Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.  Only CVs in English will be accepted. You will be responsible for: Customization of Site ICF/patient documents before sending it to sites; EC- IRB submissions; ...

  • Clinical Trial Scientst

    4 semanas atrás

    Sao Paulo, Brasil Bayer Tempo inteiro

    **Clinical Trial Scientst / Pharmaceuticals / São Paulo - SP / Hybrid Model** YOUR MISSION WILL BE TO: - Medical Data Review Plan - Prepare a medical data review plan with input and review by relevant stakeholders (Clinical Leaders, CPM, StM, DM) - Safety Tables, Figures, and Listings (TFLs): Facilitates the development of a study-specific Table of...

  • Clinical Research Associate Iii

    Há 6 dias

    Sao Paulo, Brasil MSD Tempo inteiro

    Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. - Performs clinical study site management/monitoring activities in...

  • Clinical Trial Coordinator

    3 semanas atrás

    São Paulo, Brasil Fortrea Tempo inteiro

    Requirements: Completed job training (finance), or Bachelor’s Degree 1-2 years of experience in Finance of clinical trials (focused on site payments); Advanced English Advanced Excel Hands-on Attention to details Fortrea is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Fortrea strives for diversity and inclusion in the...

  • Clinical Operations Manager

    4 semanas atrás

    São Paulo, Brasil Fortrea Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • PSI CRO Clinical Trial Administrator II

    2 semanas atrás

    São Paulo, Brasil PSICRO Tempo inteiro

    Company Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description Join our international team and be the key...

  • Clinical Trial Coordinator

    4 semanas atrás

    São Paulo, Brasil Fortrea Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Medical Manager

    4 semanas atrás

    Sao Paulo, Brasil Novo Nordisk Tempo inteiro

    Clinical Medical Manager (Black Community Inclusion) **Category**:Medical Affairs**Location**:São Paulo, São Paulo, BR- Are you passionate about advancing medical research in OSCD (other serious chronic deseases). We are seeking a skilled Clinical Medical Manager specialized in Cardiology to join our dynamic team and play a pivotal role in the execution...

  • Clinical Research Manager

    4 semanas atrás

    Sao Paulo, Brasil Fortrea Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Team Lead

    3 semanas atrás

    São Paulo, Brasil Fortrea Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Operations Manager

    4 semanas atrás

    Sao Paulo, Brasil MSD Tempo inteiro

    **Job Description**: Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. This role is accountable for performance and...

  • Clin Trials Assistant

    3 semanas atrás

    São Paulo, Brasil Fortrea Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • CMM - Clinical Medical Manager (Talent Pipeline)

    3 semanas atrás

    São Paulo, Brasil Novo Nordisk AS Tempo inteiro

    Step into the Future: Join Novo Nordisk's Talent Pipeline! Are you ready to shape the future of healthcare with Novo Nordisk? We are thrilled to announce an opportunity within our Talent Pipeline, where we actively seek top-tier professionals to join our pioneering team in the first semester of 2024. The Talent Pipeline provides an exceptional...