Manager, Study Start Up
1 semana atrás
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: Accountability & Delivery, Collaboration, Partnership and Integrity.
We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point.
In short, to be the partner of choice in drug development.That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us.
You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.
As Study Start Up Manager, you will lead a global team of Study Start Up Associates across EMEA, Americas and APAC (size of team 20 FTE) within our Centralized Patient Consent Team.
The core purpose of this role is to coordinate, lead and facilitate the activities related to preparation, review and approval of Study Master, country related and site level Informed Consent documents in accordance with internal / external SOPs as applicable e.g.
ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards; and to ensure that study authorization roles and responsibilities are focused on quality optimization, efficiencies and cost containment.
Role Responsibilities:
- To mentor and lead a team of 20 Study Start Up Associates globally, working with and through others.
- Lead and drive creation, review, and approval of Informed Consent Forms / related documentation
- Build and negotiate processes with Sponsors, Portfolio Directors
- Deliver training to members of the team as well as global study teams to ensure quality and alignment of processes
- Continually assess opportunities for process improvements and develop and monitor process change implementation.
- Provide financial oversight to ensure appropriate profitability and Monitor and manage staff workload to optimize resource utilization.
Your background and experience:
You will likely have a blend of the following skills.
Educated with a degree in Life Sciences and in depth proven clinical research industry experience.
You will have had a career to date which will have included clinical trials allowing you to have an In-depth knowledge of the Informed Consent procedure (preparation, review and approval) from a regulatory perspective.
You will possess significant experience in the preparation, review and approval of Study Master, country related and site level Informed Consent documents in accordance with int./ext.
SOPs as applicable, ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards.In a highly regulated environment and tight timelines to open study sites you should have effective prioritization skills and ability to multi-task with meticulous attention to detail.
Given that this role will lead a global team of cc individuals, you will have strong mentoring skills, team management and team leadership.
You will also have excellent interpersonal skills given that your role will have you chairing significant negotiation discussion with both internal and partners and sponsors.
Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.
All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
LI-AC1-
Study Start Up Associate
1 semana atrás
Lisboa, Lisboa, Portugal ICON plc Tempo inteiroStudy Start Up Associate - Spanish & Portuguese Speaker - Home BasedAt 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...
-
Study Start Up Associate Ii
1 semana atrás
Lisboa, Lisboa, Portugal ICON Tempo inteiroStudy Start Up Associate II - BarcelonaAt 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:...
-
Global Clinical Start Up Manager Portugal
1 semana atrás
Lisboa, Lisboa, Portugal Resourcing Life Science Tempo inteiroCompany DescriptionOur client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Clinical Start up Manager in PortugalJob OverviewLeading cross-functional project teams...
-
Sr Start-up Team Mgr
1 semana atrás
Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiroPPD, a part of Thermo Fisher Scientific, is a leading global contract research organization focused on delivering life-changing therapies. Our mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it's you We know that meaningful results not only require the right approach, but also the right people. We...
-
Lisboa, Lisboa, Portugal Tn Portugal Tempo inteirocol-wideJob Description:IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the product lifecycle. The Patient Centered Solutions (PCS) team leads the industry in generating data to ensure that the patient voice is incorporated into the development and commercialization of medication and other...
-
Lisboa, Lisboa, Portugal Iqvia Tempo inteiroIQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the product lifecycle.The Patient Centered Solutions (PCS) team leads the industry in generating data to ensure that the patient voice is incorporated into the development and commercialization of medication and other drug/non-drug...
-
Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiroSenior Project Manager- Study Operations- Patient Centered Solutions Lisboa Senior Project Manager- Study Operations- Patient Centered SolutionsLisboa Lisboa, Lisboa, Portugal col-wideJob Description:IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the product lifecycle. The Patient Centered...
-
Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiroSenior Project Manager- Study Operations- Patient Centered Solutions Lisboa Senior Project Manager- Study Operations- Patient Centered SolutionsLisboaLisboa, Lisboa, Portugal col-wideJob Description:IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the product lifecycle. The Patient Centered...
-
Lisboa, Lisboa, Portugal Iqvia Tempo inteiroSenior Project Manager- Study Operations- Patient Centered Solutions Lisboa Senior Project Manager- Study Operations- Patient Centered SolutionsLisboaLisbon, Lisbon, Portugal IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the product lifecycle. The Patient Centered Solutions (PCS) team leads...
-
Lisboa, Lisboa, Portugal IQVIA Tempo inteiroSenior Project ManagerStudy OperationsPatient Centered Solutions Lisboa Senior Project ManagerStudy OperationsPatient Centered SolutionsLisboa Lisbon, Lisbon, Portugal IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the product lifecycle. The Patient Centered Solutions (PCS) team leads the...
-
Regulatory and Start Up Specialist
1 semana atrás
Lisboa, Lisboa, Portugal Novasyte Tempo inteiroJob 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. Fluent in both Portuguese and English. At least 1 years'...
-
Regulatory and Start Up Specialist
1 semana atrás
Lisboa, Lisboa, Portugal Novasyte Tempo inteiroJob 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. Portuguese and English language proficiency.Essential...
-
Lisboa, Lisboa, Portugal Iqvia Argentina Tempo inteiroThe Role As Local Trial 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 to lead, manage and co-ordinate the conduct of clinical trials from study start-up (COLA) to close out at a country...
-
Lisboa, Lisboa, Portugal Iqvia Llc Tempo inteiroLocal Trial Manager, Single Sponsor Dedicated, home based anywhere in Portugal page is loaded Local Trial Manager, Single Sponsor Dedicated, home based anywhere in Portugal Apply locations Lisbon, Portugal time type Full time posted on Posted 2 Days Ago job requisition id R The Role As Local Trial Manager you will be responsible for running...
-
Lisboa, Lisboa, Portugal IQVIA Tempo inteiroThe Role As Local Trial 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 to lead, manage and co-ordinate the conduct of clinical trials from study start-up (COLA) to close out at a...
-
Solar Advisor p/ Start-Up
Há 11 horas
Lisboa, Lisboa, Portugal Go Work Tempo inteiroA Go Work, empresa especializada na área dos Recursos Humanos, está a recrutar para prestigiada empresa cliente 'Solar Advisor p/ Start-Up (M/F)' para Lisboa.Horário: Fulltime 8h/dia, de 2a a 6a feira.Funções: Contactar os potenciais clientes gerados através do simulador do website e apresentar com clareza e confiança os benefícios da energia solar;...
-
Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiroLocal Trial Manager, Single Sponsor Dedicated, Home Based Anywhere In Portugal Lourinhã, Lisboa Local Trial Manager, Single Sponsor Dedicated, Home Based Anywhere In Portugal Lisboa Lisboa, Lisboa, Portugal col-wideJob Description:The RoleAs Local Trial Manager you will be responsible for running international/global studies in all therapeutic areas,...
-
Lisboa, Lisboa, Portugal Fitness UP, Lda Tempo inteiroO Fitness UP é uma rede de ginásios que atualmente conta com mais de 45 clubes abertos de norte a sul do país e em forte expansão, sendo umas das maiores referências do Fitness em Portugal, e está a recrutar para as suas instalações na Zona da Grande Lisboa e na Zona do Grande Porto: SUPERVISORDe ti precisamos: Experiência comprovada de pelo menos 1...
-
Lisboa, Lisboa, Portugal Fitness UP, Lda Tempo inteiroO Fitness UP é uma rede de ginásios que atualmente conta com mais de 45 clubes abertos de norte a sul do país e em forte expansão, sendo umas das maiores referências do Fitness em Portugal, e está a recrutar para as suas instalações na Zona da Grande Lisboa e na Zona do Grande Porto: SUPERVISORDe ti precisamos: Experiência comprovada de pelo menos 1...
-
Lisboa, Lisboa, Portugal Fitness UP, Lda Tempo inteiroO Fitness UP é uma rede de ginásios que atualmente conta com mais de 45 clubes abertos de norte a sul do país e em forte expansão, sendo umas das maiores referências do Fitness em Portugal, e está a recrutar para as suas instalações na Zona da Grande Lisboa e na Zona do Grande Porto: SUPERVISORDe ti precisamos: Experiência comprovada de pelo menos 1...
