Regulatory and Start Up Specialist

Há 3 dias


Oeiras, Portugal IQVIA Tempo inteiro

**Job Overview**

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. **Portuguese and English language proficiency.**

**Essential Functions**

Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Review and provide feedback to management on site performance metrics.
Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
Inform team members of completion of regulatory and contractual documents for individual sites.
Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives.

**Qualifications**
**Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research** or other relevant experience; or equivalent combination of education, training and experience.
In-depth knowledge of clinical systems, procedures, and corporate standards.



  • Oeiras, Portugal IQVIA Tempo inteiro

    Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve...


  • Oeiras, Lisboa, Portugal IQVIA Tempo inteiro

    Job OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.Essential Functions Under general supervision, serve as...

  • Sso Study Start-up Manager

    3 semanas atrás


    Oeiras, Portugal Novartis Tempo inteiro

    100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine -...

  • Sso Study Start-up Manager

    1 semana atrás


    Oeiras, Lisboa, Portugal Novartis Tempo inteiro

    100,000+ That's how many patients participate in our clinical trials at any given time. GCO is Novartis' powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine -...

  • Junior Regulatory Affairs

    1 semana atrás


    Oeiras, Lisboa, Portugal HAYS Portugal Tempo inteiro

    Your new company Join a multinational company in the Pharmaceutical Industry.Your new role Reporting to the Regulatory Affairs Manager, your main responsibilities will be: Supporting the local implementation of new initiatives, management tools, or processes in cooperation with RA-EMEA. Ensuring that regulatory processes, procedures, and files are...

  • Avionics Support Specialist

    3 semanas atrás


    Oeiras, Portugal NetJets Europe Tempo inteiro

    **Purpose of Position**: In coordination with the Avionics Technical Specialist, provides technical support and advice to Maintenance personnel and Flight crew on avionics (electrical and electronic aircraft equipment) maintenance activities to achieve best level of safety, performance, reliability and compliance with regulatory requirements and most cost...

  • Sr Clinical Trial Assistant

    3 semanas 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...

  • Avionics Support Specialist

    3 semanas atrás


    Oeiras, Portugal NetJets Transportes Aéreos, S.A. Tempo inteiro

    Company: NetJets Transportes Aéreos, S.A.- Area of Interest: Maintenance- Location: Paço de Arcos, PT, 2774-550- Req ID: 9565**Purpose of Position**: In coordination with the Avionics Technical Specialist, provides technical support and advice to Maintenance personnel and Flight crew on avionics (electrical and electronic aircraft equipment) maintenance...

  • Clinical Trial Assistant 2

    1 semana atrás


    Oeiras, Lisboa, Portugal IQVIA Tempo inteiro

    Clinical Trial Administrator, Single Sponsor dedicatedJob 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...


  • 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...

  • Avionics Support Specialist

    1 semana atrás


    Oeiras, Lisboa, Portugal NetJets Europe Tempo inteiro

    Purpose of Position:In coordination with the Avionics Technical Specialist, provides technical support and advice to Maintenance personnel and Flight crew on avionics (electrical and electronic aircraft equipment) maintenance activities to achieve best level of safety, performance, reliability and compliance with regulatory requirements and most cost...


  • Oeiras, Lisboa, Portugal Transparente Listoo S.A. Tempo inteiro

    About Us: Situated in Linda-a-Velha, we are a Portuguese start-up in the Proptech industry, offering a new concept for buying and selling houses. As we expand, we are looking for a Digital Marketing Specialist to join our team.Responsibilities: Write SEOfriendly blogs and upload longform SEO articles. Develop lead nurturing strategies. Help the Marketing...


  • Oeiras, Portugal NetJets Europe Tempo inteiro

    **Purpose of Position**: Provide specialist regulatory, logístical and administrative support, throughout the full training cycle, for all crew training events, to execute the Quarterly Training Plan (QTP) in accordance with Training Department policies and procedures. Ensure legal/regulatory compliance and cost effectiveness of training, whilst providing...

  • Crew Training Specialist

    4 semanas atrás


    Oeiras, Portugal NetJets Transportes Aéreos, S.A. Tempo inteiro

    Company: NetJets Transportes Aéreos, S.A.- Area of Interest: Flight Operations- Location: Paço de Arcos, PT, 2774-550- Req ID: 9062**Purpose of Position**: Provide specialist regulatory, logístical and administrative support, throughout the full training cycle, for all crew training events, to execute the Quarterly Training Plan (QTP) in accordance with...

  • Crew Training Specialist

    3 semanas atrás


    Oeiras, Portugal NetJets Europe Tempo inteiro

    **Purpose of Position**: Provide specialist regulatory, logístical and administrative support, throughout the full training cycle, for all crew training events, to execute the Quarterly Training Plan (QTP) in accordance with Training Department policies and procedures. Ensure legal/regulatory compliance and cost effectiveness of training, whilst providing...

  • Crew Training Specialist

    1 semana atrás


    Oeiras, Lisboa, Portugal NetJets Europe Tempo inteiro

    Purpose of Position:Provide specialist regulatory, logístical and administrative support, throughout the full training cycle, for all crew training events, to execute the Quarterly Training Plan (QTP) in accordance with Training Department policies and procedures. Ensure legal/regulatory compliance and cost effectiveness of training, whilst providing direct...

  • Crew Training Supervisor

    4 semanas atrás


    Oeiras, Portugal NetJets Europe Tempo inteiro

    **Purpose of Position**: Managing a team of crew training specialists, this position is responsible for ensuring that the crew training plan is implemented and controlled to efficiently support safe flight operation with trained and qualified crew members, in line with company objectives and in compliance with all regulations and company policies. **Tasks...


  • Oeiras, Lisboa, Portugal Amplifon SPA Tempo inteiro

    Amplifon is the global leader in the hearing care retail industry. Since 1950 we've been changing the lives of millions of customers all around the world. And though we are a global company that's constantly growing, we have a start-up approach and strive for innovation every day. We take pride in setting the standard for our industry and constantly...


  • Oeiras, Portugal NetJets Europe Tempo inteiro

    **Purpose of Position**: The Procurement Database Specialist collects analyses and consolidates data for maintaining Procurement databases, ensuring integrity of information, in order to comply with internal needs. The Procurement Database Specialist enters data into databases or other computerised systems to maintain up-to-date supplier and pricing...

  • Crew Training Supervisor

    1 semana atrás


    Oeiras, Lisboa, Portugal Executive Jet Management, Inc. Tempo inteiro

    Select how often (in days) to receive an alert:Area of Interest: Flight OperationsLocation:Paço de Arcos, PT, Purpose of PositionManaging a team of crew training specialists, this position is responsible for ensuring that the crew training plan is implemented and controlled to efficiently support safe flight operation with trained and qualified crew...