Sr Clinical Trial Assistant

5 meses atrás


Oeiras, Portugal IQVIA Tempo inteiro

Clinical Trial Administrator, Single Sponsor dedicated

Job Overview:
CTA performs 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. By assisting in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) the Clinical Trial Assistant ensures quality and consistency of study deliverables to time, cost and quality objectives.

Essential Functions:

- Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems like Trial Master File that track site compliance and performance within project timelines.
- Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
- Assist with periodic review of study files for completeness.
- Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- May collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Qualifications:

- High School or University Diploma
- Clinical research administrative support experience preferred
- Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
- Written and verbal communication skills including good command of Portuguese and English language.
- Effective time management and organizational skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Basic knowledge of applicable clinical research regulatory requirement, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
- Knowledge of applicable protocol requirements as provided in company training.



  • Oeiras, Portugal IQVIA Tempo inteiro

    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 clinical documents and...


  • Oeiras, Portugal IQVIA Tempo inteiro

    Internal Job Description As Local Clinical Project Manager you will be responsible for running international/global studies in all therapeutic areas, managing the operational aspects of projects to meet contractual requirements. You will act as primary point of contact in Romania to lead, manage and co-ordinate the conduct of clinical trials at a country...


  • Oeiras, Portugal IQVIA Tempo inteiro

    Job Overview Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs,...

  • Rwe Internship

    2 semanas atrás


    Oeiras, Portugal IQVIA Tempo inteiro

    **Job Overview**: We are seeking a motivated and detail-oriented Real-World Evidence (RWE) Intern to provide support for our clinical trials and evidence projects. This role offers a unique opportunity to gain hands-on experience in observational studies, monitoring tasks, and start-up activities, including the management of ethics committees and contracts...

  • Quality Control Analyst

    6 meses atrás


    Oeiras, Portugal GenIbet Biopharmaceuticals Tempo inteiro

    GenIbet is a cGMP biopharmaceutical CMO (Contract Manufacturing Organization) offering highly specialized microbial, cell culture and viral process development and cGMP manufacturing services to research groups, biotech and pharma companies. GenIbet's core activity is the manufacture and supply of materials for use in early stage drug development,...


  • Oeiras, Portugal IQVIA Tempo inteiro

    **Job Overview** Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. **Essential Functions** - Oversee the execution of Site Activation (including pre-award/bid defense...


  • Oeiras, Portugal IQVIA Tempo inteiro

    We are currently recruiting for freelance registered nurses for Lisbon. As a freelance nurse you will **visit clinical trial patients in their homes **to take blood, provide support and education and/or administer medication. The workload can vary from week to week but can be planned in advance according to the patients and nurses availability. **Job...

  • Analyst Rwe

    5 meses atrás


    Oeiras, Portugal IQVIA Tempo inteiro

    With approximately 85,000 employees in more than 100 countries, IQVIA is in a truly unique position to be able to support companies seeking to improve real-world patient outcomes and enhanced clinical trial outsourcing through treatment innovations, care provision and access. With a broad range of healthcare information, technology and service offerings,...

  • Sales Administrator

    4 meses atrás


    Oeiras, Portugal IQVIA Tempo inteiro

    **With approximately 70,000 employees in more than 100 countries, IQVIA is in a truly unique position to be able to support companies seeking to improve real-world patient outcomes and enhanced clinical trial outsourcing through treatment innovations, care provision and access. With a broad range of healthcare information, technology and service offerings,...