Manager, Study Start Up

2 tygodni temu

Warszawa, Mazovia, Polska ICON Pełny etat

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 18 – 20 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.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below

A better career. A better world. A better you.

Our people are our greatest strength , are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers , deliver results to help bring life-changing medicine and devices to market and maintain ICON's success as an industry leader .
See all locations

Read more

A better career. A better world. A better you.

Our people are our greatest strength , are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers , deliver results to help bring life-changing medicine and devices to market and maintain ICON's success as an industry leader .
See all locations

Read more

A better career. A better world. A better you.

Our people are our greatest strength , are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers , deliver results to help bring life-changing medicine and devices to market and maintain ICON's success as an industry leader .
See all locations

Read more

A better career. A better world. A better you.

Our people are our greatest strength , are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers , deliver results to help bring life-changing medicine and devices to market and maintain ICON's success as an industry leader .
See all locations

Read more

A better career. A better world. A better you.

Our people are our greatest strength , are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers , deliver results to help bring life-changing medicine and devices to market and maintain ICON's success as an industry leader .
See all locations

Read more

Things to consider heading into 2023 if you're thinking about moving jobs.

Life sciences are undeniably an exciting area to start and pursue a career in.

#J-18808-Ljbffr

  • Study Start-Up Lead

    2 tygodni temu

    Warszawa, Mazovia, Polska Rho, Inc. Pełny etat

    OverviewJoin us in redefining what it means to work for a CRO. Working at Rho, you'll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity's biggest challenges.At Rho, we're committed to you just as you're committed to us. You'll have the opportunity to...

  • Study Start Up Associate II

    2 tygodni temu

    Warszawa, Mazovia, Polska ICON Pełny etat

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.With our patients at the centre of all that we do, we help to accelerate the development...

  • Study Start-Up Site Manager with French language

    2 tygodni temu

    Warszawa, Mazovia, Polska IQVIA LLC Pełny etat

    Study Start-Up Site Manager with French language (prior experience needed) page is loaded Study Start-Up Site Manager with French language (prior experience needed) Apply locations Sofia, Bulgaria Belgrade, Serbia Budapest, Hungary Warsaw, Poland Zagreb, Croatia time type Full time posted on Posted 30+ Days Ago job requisition id R Site Manager Study...

  • Study Start Up and Regulatory Affairs Specialist

    2 tygodni temu

    Warszawa, Mazovia, Polska Ergomed Pełny etat

    Job Description We are looking for someone who can speak German Provides Study Start-Up Specialist activities in support of assigned projects including regulatory submissions, informed consent review, site contract/budget negotiation, essential document collection and review in preparation of site initiation and activation. Provides leadership to...

  • Study Start-Up Site Manager with French language

    2 tygodni temu

    Warszawa, Mazovia, Polska IQVIA Pełny etat

    Site Manager Study Start-Up Real-World Evidence EMEA based Join us on our exciting journey IQVIA Real-World Evidence (RWE) teams work with clients to help them collect and use real-world data to generate evidence to meet the needs of regulators, payers, providers, and patients. Our approach is unique in the industry and is defining the way...

  • Start-up Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska in4ge Pełny etat

    Start-up Manager Branża: sprzedaż online (survival/ militaria)Tryb pracy: 100% zdalny z dowolnego miejsca na świecieForma współpracy: B2BOpis RoliDla naszego Klienta poszukujemy ambitnego i doświadczonego Start-up Managera, który będzie odpowiedzialny za rozwój nowego biznesu oraz skuteczną realizację strategii sprzedaży online w branży...

  • Start-up Manager @

    2 tygodni temu

    Warszawa, Mazovia, Polska In4ge Sp. Z O.o. Pełny etat

    Dla naszego Klienta poszukujemy ambitnego i doświadczonego Start-up Managera, który będzie odpowiedzialny za rozwój nowego biznesu oraz skuteczną realizację strategii sprzedaży online w branży survival.U Kandydatów na to stanowisko cenimy szczególnie innowacyjność, kreatywność i zaangażowanie w działanie.Branża: sprzedaż online (survival/...

  • Senior Technical Project Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake – software development is just a part of what we do at Startup House. Our mission is to deliver all-around support for startups at all stages of development. Our Project Management Team is growing and looking for fresh blood – we're currently searching for an experienced...

  • Freelance Designer

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    Hi thereWe know well the enhancing effects freedom and flexibility have on the work and lifestyle of a freelance designer. A flexible workload, the opportunities to choose projects, location independence... As all this holds much value for the design professional, we have a solution for addressing these needs.Who are we?We're about supercharging tech-based...

  • QA Freelancer

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake – software development is just a part of what we do at Startup House. Our mission is to deliver all-around support for startups and growing companies at all stages of development.We connect talented freelancers with cutting-edge projects, offering a platform for you to showcase your...

  • Front-end Freelancer

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake – software development is just a part of what we do at Startup House. Our mission is to deliver all-around support for startups and growing companies at all stages of development.We connect talented freelancers with cutting-edge projects, offering a platform for you to showcase your...

  • Back-end Freelancer

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake – software development is just a part of what we do at Startup House. Our mission is to deliver all-around support for startups and growing companies at all stages of development.We connect talented freelancers with cutting-edge projects, offering a platform for you to showcase your...

  • Developer

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake - software development is just a part of what we do at Startup Development House. Our mission is to deliver all-around support for startups at all stages of development.Our Development Team is expanding and looking for fresh blood - we're currently looking for a Developer, who will...

  • Senior Developer

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake - software development is just a part of what we do at Startup Development House. Our mission is to deliver all-around support for startups at all stages of development.Our Development Team is expanding and looking for fresh blood - we're currently looking for a Developer, who will...

  • QA Engineer

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake – software development is just a part of what we do at Startup House. Our mission is to deliver all-around support for startups at all stages of development.OurQA Teamis growing and looking for fresh blood – we're currently searching for an experiencedQuality Assurance...

  • Global Study Associate

    2 tygodni temu

    Warszawa, Mazovia, Polska AstraZeneca Pełny etat

    At AstraZeneca, we are guided in our work by a strong set of values, and we're resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we're on a mission to turn ideas into life-changing...

  • Global Study Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska AstraZeneca Pełny etat

    Global Study Manager is a valuable member of the extended global study team, supporting the efficient delivery of clinical studies within Global Medicines Development (GMD). The role involves overseeing the entire study process, from Clinical Study Protocol (CSP) development to study archiving, ensuring timely, cost-effective, and high-quality outcomes.The...

  • Global Study Director BioPharmaceuticals

    2 tygodni temu

    Warszawa, Mazovia, Polska AstraZeneca Pełny etat

    Locations: Barcelona, Spain (on-site) Warsaw, Poland (on-site) Mississauga, Canada (on-site) The Global Study Director (GSD) is a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, whose main accountability is the operational planning and delivery of high priority and complex clinical studies or multiple...

  • Environmental Study Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska AstraZeneca Pełny etat

    Environmental Study ManagerLocation: Macclesfield, UK / Gothenburg, SWE / Södertälje, SWE / Warsaw, POLAre you passionate about environmental sustainability and eager to contribute to the environmental safety of life-changing medicines? We are seeking an Environmental Study Manager to join our Global SHE and Operations Sustainability function. This role is...

  • Marketing Specialist

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake – software development is just a part of what we do at Startup House. Our mission is to deliver all-around support for companies at all stages of development.Our team is currently looking for a Marketing Specialist, who will help us develop our marketing initiatives. This is a...