Vaga de parceiro

Clin Trial Assist Gicors Be - Rio de Janeiro / RJ

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Detalhes da Vaga

  • Escolaridade Não Informado
  • Segmento Não Informado
  • Salário Não Informado
  • Área de AtuaçãoDiversos / Outros

O que você irá fazer

  • We are the people of PPD thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health.
  • You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
  • ****Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools.
  • Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.
  • ****As a PPD Clinical Trial Coordinator you will provide administrative and technical support to the Project Team.
  • You will support audit readiness by ensuring files are reviewed on schedule detailed in the organization''s WPD and department guidance document.
  • ****At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team.
  • We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
  • ****Summarized Purpose**:**Provides administrative and technical support to the Project Team.
  • Supports audit readiness by ensuring files are reviewed on schedule detailed in the organization''s WPD and department guidance document.
  • ****Essential Functions**:- ** According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
  • **:- ** Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
  • **:- ** Ensures allocated tasks are performed on time, within budget and to a high-quality standard.
  • Proactively communicates any risks to project leads.
  • **:- ** Supports 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.
  • **:- ** Provides system support (i.
  • E.
  • GoBalto & eTMF).
  • **:- ** Supports RBM activities.
  • **:- ** 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, performing mass mailings and communications as needed, providing documents and reports to internal team members.
  • **:- ** Supports scheduling of client and/or internal meetings.
  • **:- ** Reviews and tracks local regulatory documents.
  • **:- ** Transmits documents to client and centralized IRB/IEC.
  • **:- ** Analyzes and reconciles study metrics and findings reports.
  • Assists with clarification and resolution of findings related to site documentation.
  • **:- ** Maintains vendor trackers.
  • **:- ** 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.
  • ****Qualifications - External****Education and Experience**:**High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
  • ****Bachelor''s degree preferred.
  • ****Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
  • ****In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
  • ****Knowledge, Skills and Abilities**:- ** Ability to work in a team or independently as required**:- ** Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively**:- ** Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency**:- ** Strong customer focus**:- ** Flexibility to reprioritize workload to meet changing project timelines**:- ** Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout**:- ** Good English language and grammar skills and proficient local language skills as needed**:- ** Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems**:- ** Ability to successfully complete PPD clinical training program**:- ** Self-motivated, positive attitude and good interpersonal skills****Working Environment**:**PPD values the health and wellbeing of our employees.
  • We support and encourage indivi

Informações Adicionais

  • Quantidade de Vagas 1
  • Jornada Não Informado