Study Start Up Specialist
7 meses atrás
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
**Join Our Team as a** **Study Start Up Specialist - (home based in Portugal.**
**About this role**
As part of our **Study Start Up** team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.
The **Study Start Up Specialist** is part of the Site Management and Start Up Unit, within TFS Develop and will function operationally as a member of a Project Team being responsible of startup activities according to company policies, SOPs and regulatory requirements in addition to financial and contractual obligations.
The **Study Start Up Specialist **must contribute to ensure the planned start up plan is executed maximizing the recruitment window of assigned studies. As part of the job function will perform activities associated with feasibility and site identification, study site initiation process, interact with Ethics Committees or deal with investigator contracts.
**Key Responsibilities**:
- Performs the startup activities of assigned studies within a country or region ensuring that those are performed on-time, within the scope and in compliance with ICH/GCP guidelines, SOPs and protocol requirements.
- Collect, review, approve process and track regulatory & investigator documents required for study site activation.
- Prepare and complete regulatory process (IEC/IRBs) including ask for requirements to the EC/IRBSs, prepare and collecting specific documentation, submission and amendments, regulatory fees.
- Collaborate with Regulatory department regarding HA/CA submission/notification.
- Main responsible of ensuring the quality control of documentation included in any submission/notification.
- Adapt Informed Consent documents according to local law and document the process following guidelines and SOPs.
- Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
**Qualifications**:
- Bachelor’s Degree preferred
- Good knowledge of GCP/ICH guidelines
- Good Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards
- Minimum 1-3 years of relevant clinical experience
- Previous experience with investigator start-up documents and investigative sites is preferred
- Good written and communication skills in English and Portuguese
- Good organizational skills and experience working with cross functional teams
- Strong software and computer skills
- Capable of multi-tasking and working well under pressure to meet deadline coupled with a good understanding of working in a team environment
- Travel within this position is limited
**What We Offer**
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
**A Bit More About Us**
Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.
Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.
**#Together we make a difference
-
Regulatory Affairs Specialist
Há 1 mês
Lisboa, Lisboa, Portugal Icon Plc Tempo inteiroEmbark on a challenging career opportunity as a Regulatory Affairs Specialist at Icon Plc, a leading healthcare intelligence and clinical research organization.We are seeking an experienced individual to lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency...
-
Study Start Up Associate
Há 1 mês
Lisboa, Portugal ICON Plc Tempo inteiroStudy Start Up Associate II - Fluent Dutch Required ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Study Start Up Associate / Regulatory...
-
Study Start Up Associate Ii
6 meses atrás
Lisboa, Portugal ICON Tempo inteiroStudy Start Up Associate II At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation:...
-
Study Start Up Associate Ii
7 meses atrás
Lisboa, Portugal ICON plc Tempo inteiroStudy Start Up Associate II At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation:...
-
Study Start Up Associate
Há 1 mês
Lisboa, Portugal Icon Plc Tempo inteiroStudy Start Up Associate II - Fluent Dutch RequiredICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.What You Will Be Doing:Leading the preparation and...
-
Clinical Trial Start-Up Specialist
2 meses atrás
Lisboa, Lisboa, Portugal Icon Tempo inteiroJob Summary:We are seeking a highly skilled SITE ACTIVATION LEAD to join our team at ICON. As a key member of our clinical operations team, you will be responsible for advancing clinical trial start-up activities and ensuring the successful delivery of our projects.Key Responsibilities:• Advance clinical trial start-up activities by understanding client...
-
Clinical Study Support Specialist
2 semanas atrás
Lisboa, Lisboa, Portugal Iqvia Tempo inteiroAt Iqvia, we are seeking a highly skilled Clinical Study Support Specialist to join our team. This role is an excellent opportunity for individuals who are passionate about the pharmaceutical industry and want to make a difference in patient care.As a Clinical Study Support Specialist, you will be the primary point of contact for patients and healthcare...
-
Sr Clinical Trial Assistant/Start-Up
5 meses atrás
Lisboa, Portugal Iqvia Argentina Tempo inteiroClinical 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...
-
Robotic Surgery Start-up Specialist
6 meses atrás
Lisboa, Portugal Medtronic Tempo inteiroThe surgical robotics utilization team manages all aspects of system installation, start-up, customer training, account analysis, drive and optimize the robotic program. Placement of a HUGO surgical robot in the hospital requires full-time support for an account specific period to ensure successful integration into the hospital’s service lines. The...
-
Sustainability Cto
3 meses atrás
Lisboa, Portugal Ewor Gmbh Tempo inteiroWith unicorn founders like Paul Müller as part of the founders and team, we help outstanding talents and serial entrepreneurs build and scale their ventures. Our three founders - Daniel, Alex, and Florian - are accomplished serial entrepreneurs with a wealth of experience. EWOR's leadership team has built and exited 7 companies before, including a €1.2BN...
-
Sustainability Cto
3 meses atrás
Lisboa, Portugal Ewor Gmbh Tempo inteiroWith unicorn founders like Paul Müller as part of the founders and team, we help outstanding talents and serial entrepreneurs build and scale their ventures.Our three founders - Daniel, Alex, and Florian - are accomplished serial entrepreneurs with a wealth of experience. EWOR's leadership team has built and exited 7 companies before, including a €1.2BN...
-
Regulatory and Start Up Specialist
6 meses atrás
Lisboa, Portugal Novasyte Tempo inteiroJob 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. Fluent in both Portuguese and English. At least 1 years'...
-
Senior Clinical Study Manager for Global Clinical Trials
2 semanas atrás
Lisboa, Lisboa, Portugal Mygwork - Lgbtq+ Business Community Tempo inteiroUnlock your potential as a Senior Clinical Study Manager at Mygwork - LGBTQ+ Business Community, where diversity and inclusion thrive. We are seeking an experienced professional to lead clinical trials with moderate complexity, providing quality oversight and driving decision-making.Job SummaryAs a Senior Clinical Study Manager, you will be responsible for...
-
Visionary Tech Strategist for Ambitious Start-Up
1 semana atrás
Lisboa, Lisboa, Portugal Buscojobs Portugal Tempo inteiroAbout UsWe're an innovative start-up that prioritizes cutting-edge technology in all our projects. We're seeking a skilled CTO - Chief Technology Officer (Full Remote) to lead our tech strategy and drive growth from the comfort of their home.Your Responsibilities:Develop and implement a comprehensive tech vision, positioning us as a key player in the...
-
Regulatory Start-up/site Activation Specialist
6 meses atrás
Lisboa, Portugal Novasyte Tempo inteiroEssential 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...
-
Ai Ceo At Your Own Start-Up
Há 1 mês
Lisboa, Portugal Ewor Gmbh Tempo inteiroWith unicorn founders like Paul Müller as part of the founders and team, we help outstanding talents and serial entrepreneurs build and scale their ventures.Our three founders - Daniel, Alex, and Florian - are accomplished serial entrepreneurs with a wealth of experience. EWOR's leadership team has built and exited 7 companies before, including a €1.2BN...
-
Traveltech Ceo At Your Own Start-Up
4 meses atrás
Lisboa, Portugal Ewor Gmbh Tempo inteiroWith unicorn founders like Paul Müller as part of the founders and team, we help outstanding talents and serial entrepreneurs build and scale their ventures.Our three founders - Daniel, Alex, and Florian - are accomplished serial entrepreneurs with a wealth of experience. EWOR's leadership team has built and exited 7 companies before, including a €1.2BN...
-
Robotic Surgery Start-up Specialist
2 semanas atrás
Lisboa, Portugal Medtronic Tempo inteiroAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life **:The surgical robotics utilization team manages all aspects of system installation,...
-
Robotic Surgery Start-up Specialist
4 meses atrás
Lisboa, Portugal Medtronic Tempo inteiroAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life The surgical robotics utilization team manages all aspects of system installation, start-up,...
-
Robotic Surgery Start-Up Specialist
Há 7 dias
Lisboa, Portugal Phiture Tempo inteiroAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeThe surgical robotics utilization team manages all aspects of system installation, start-up, customer...