Manager, Study Start Up
hace 2 semanas
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 fulfill our mission to advance and improve patients' lives.
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations.
With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Role:
As Study Start Up Manager, you will lead a team of Study Start Up Associates. 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.- To mentor and lead a team of Study Start Up Associates, 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.
To be successful in the role, you will have:
- 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 team, 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 knowledge, capabilities and quality of our people. That is why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best-in-class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, 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-DT2
LI-Hybrid
-
Study Start Up Associate I
hace 3 semanas
Tlahuac, México ICON A tiempo completoThe Study Start Up. Assocate II, collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP. Embrace and contribute to ICON’s culture of quality and process...
-
Study Star Up
hace 2 semanas
Tlahuac, México CIDVID A tiempo completoSomos un holding mexicano con presencia global y con diversas líneas de negocio, pero con un fin en particular: PROCURAR LA SALUD Y EL BIENESTAR DEL SER HUMANO ¡ÚNETE A NUESTRO EQUIPO DE TRABAJO COMO STUDY START UP! El Study Start Up es el responsable de coordinar y dar seguimiento a los procesos de inicio y cierre de los estudios clínicos, atracción...
-
Study Start Up Associate I-biotech
hace 3 semanas
Tlahuac, México ICON plc A tiempo completoAt 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,...
-
Study Start Up Associate I
hace 3 semanas
Tlahuac, México ICON plc A tiempo completoAt 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,...
-
Study Start Up Associate I
hace 3 semanas
Tlahuac, México ICON A tiempo completoAt 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,...
-
Start-up & Regulatory Specialist
hace 2 semanas
Tlahuac, México Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Study Support Assistant
hace 2 semanas
Tlahuac, México Icon plc A tiempo completoAt 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 fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...
-
Auxiliar de Compras
hace 2 semanas
Tlahuac, México CAVI A tiempo completo¡Únete a nuestro equipo! Somos la empresa líder en movilidad de LATAM que busca empoderar a los usuarios de las principales ciudades de México y LATAM ofreciéndoles soluciones en logística, movilidad y consumo. ¡Queremos que formes parte de este gran equipo! **Auxiliar de Compras** ¡Si cuentas con experiência en Apps, Start Up, Ecosistemas...
-
Data Migration Manager, Mexico, Remote
hace 3 semanas
Tlahuac, México Fundraise Up A tiempo completo**Highlights**: - Base Pay Range: $18K - $24K- Equity compensation- Revenue share compensation **About this role**: We're in search of a Data Migration Manager to join our dynamic team. In this role, you'll take charge of moving our clients' data from their old platforms to ours, a task that involves coordination, accuracy checks, scheduling, and execution....
-
Clinical Trial Manager
hace 3 semanas
Tlahuac, México Icon plc A tiempo completoAt 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,...
-
Associate Safety Reporting Manager
hace 2 semanas
Tlahuac, México Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Cra 1
hace 2 semanas
Tlahuac, México Novasyte A tiempo completoJob Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...
-
Assistant Cra
hace 4 semanas
Tlahuac, México Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Assistant Cra
hace 4 semanas
Tlahuac, México Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Assistant Cra
hace 2 semanas
Tlahuac, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Other **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...
-
Cra 2
hace 3 semanas
Tlahuac, México Novasyte A tiempo completoJob Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...
-
Analista Financiero start Up
hace 2 semanas
Tlahuac, México CTPG A tiempo completo**Importante fintech internacional solicita: Analista Financiero** **Requisitos**: - Experiência realizando Análisis Financieros - Conocimientos de riesgos de mercado - Liquidez de crédito - Métodos de Valuación - Tablas de amortización - Corridas financieras **OFRECEMOS**: - Sueldo bruto mensual: $50,000 - 65,000 (De acuerdo a experiência -...
-
Project Manager, Global Engineering Services Start
hace 2 semanas
Tlahuac, México Servicios Comerciales Amazon Mexico S. de R.L. de C.V. A tiempo completo3+ years of program or project management experience - 3+ years of working cross functionally with tech and non-tech teams experience - 3+ years of defining and implementing process improvement initiatives using data and metrics experience - Bachelor's degree - Experience defining program requirements and using data and metrics to determine improvements -...
-
Project Manager
hace 2 semanas
Tlahuac, México Growth Partners Up A tiempo completoProject Manager - Importante empresa dedicada a logística de distribución de productos farmacéuticos, higiene y belleza personal, está en busca de talento para proyecto de 6 meses_ ¡Únete a nuestro equipo! **Requisitos**: Sexo: indistinto Edad: a partir de 25 años Escolaridad: Ingeniería en Sistemas o afín Experiência de 2 años administrando...
-
Coordinating Cra
hace 3 semanas
Tlahuac, México Novasyte A tiempo completoJob Overview Perform monitoring and site management work for a variety of protocols, site and therapeutic areas. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International...
