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Ovaj oglas je istekao 23.02.2015. i više nije aktivan.
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Ovaj oglas je istekao 23.02.2015. i više nije aktivan.
Sadržaj oglasa prikazan je isključivo u informativne svrhe.
Trenutno aktivne oglase pogledajte na www.posao.hr.
Sr SSU & Reg Project Manager (m/f)
Oglas je istekao
Poslodavac:
Kategorija:
Mjesto rada:
Europe - UK, Camberley
Rok prijave:
23.02.2015.
O poslu
Opis radnog mjesta:
Sr SSU & Reg Project Manager - (15001074)
Description
Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development. From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we’ve continued to improve what we do.
We are currently looking to strengthen our Ethics and Regulatory department and are seeking a Senior Site Start UP & Regulatory Project Manager to be based in Europe.
A brief summary of duties you will be involved in:
- Providing oversight of all the project SSU activities, which encompases all activities from site selection through site activation-ready.
- Serving as the primary global liaison during SSU.
- Assisting in the management of multifunctional leads associated with SSU.
- Developing and managing integrated site start-up timelines and reporting weekly progress including plans to address potential timing risks/gaps.
Description
Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development. From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we’ve continued to improve what we do.
We are currently looking to strengthen our Ethics and Regulatory department and are seeking a Senior Site Start UP & Regulatory Project Manager to be based in Europe.
A brief summary of duties you will be involved in:
- Providing oversight of all the project SSU activities, which encompases all activities from site selection through site activation-ready.
- Serving as the primary global liaison during SSU.
- Assisting in the management of multifunctional leads associated with SSU.
- Developing and managing integrated site start-up timelines and reporting weekly progress including plans to address potential timing risks/gaps.
Vrsta posla:
stalni radni odnos, rad na određeno vrijeme
Županija:
Država:
Europe - UK, Camberley
O zaposleniku
Znanja i kvalifikacije:
Qualifications
To succeed in this role you will need the following skills/experience:
• BA/BS degree in the science/health care field, legal degree, or equivalent combination of education and experience.
• Experience with leading at least ten (10) studies from award and into maintenance and for at least ten (10) sponsors and at least three (3) clinical trial phases; at least five (5) of those studies must have included countries from multiple regions.
• Experience leading a single site with at least fifteen (15) countries.
• Thorough understanding of the regulatory laws, processes, mindset, document requirements, drug labeling requirements, and drug release requirements in home region and good general understanding of those in other regions.
Why choose us:
It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.
We’ve got an attitude at INC: “Can do, I own it.” Absolutely everyone has ownership of what they do here. And because we’re given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.
“We were ranked “Top CRO” to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide).”
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
Primary Location: Europe - UK, Camberley
Other Locations: Europe - South Africa, Illovo, Europe - South Africa Regional, Europe - Portugal Regional, Europe - Germany Regional, Europe - France Regional, Europe - UK Regional, Europe - Denmark Regional, Europe - Belgium, Zaventem, Europe - Sweden Regional, Europe - Italy Regional, Europe - Czech Republic Regional, Europe - Spain Regional, Europe - Netherlands Regional, Europe - Sweden, Uppsala, Europe - Ukraine Regional, Europe - Switzerland Regional, Europe - Serbia, Belgrade, Europe - Russia Regional, Europe - Germany, Munich, Europe - UK, Lewes, Europe - Serbia Regional, Europe - Israel Regional, Europe - Poland Regional, Europe - Bulgaria Regional, Europe - Italy, Saronno, Europe - Poland, Warsaw, Europe - Hungary, Budapest, Europe - Germany, Langenfeld, Europe - Bulgaria, Sofia, Europe - Belgium Regional, Europe - Spain, Barcelona, Europe - Hungary Regional, Europe - Spain, Madrid, Europe - France, Issy Les Moulineaux, Europe - Israel, Tel Aviv, Europe - Romania, Bucharest, Europe - Czech Republic, Prague, Europe - Romania Regional, Europe - Ukraine, Kiev, Europe - Poland, Krakow, Europe - Scotland, Edinburgh, Europe - Russia, Moscow, Europe - Netherlands, Amsterdam
Job: Site Start Up
Schedule: Full-time
Travel: Yes, 25 % of the Time
Employee Status: Regular
Apply online
To succeed in this role you will need the following skills/experience:
• BA/BS degree in the science/health care field, legal degree, or equivalent combination of education and experience.
• Experience with leading at least ten (10) studies from award and into maintenance and for at least ten (10) sponsors and at least three (3) clinical trial phases; at least five (5) of those studies must have included countries from multiple regions.
• Experience leading a single site with at least fifteen (15) countries.
• Thorough understanding of the regulatory laws, processes, mindset, document requirements, drug labeling requirements, and drug release requirements in home region and good general understanding of those in other regions.
Why choose us:
It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.
We’ve got an attitude at INC: “Can do, I own it.” Absolutely everyone has ownership of what they do here. And because we’re given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.
“We were ranked “Top CRO” to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide).”
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
Primary Location: Europe - UK, Camberley
Other Locations: Europe - South Africa, Illovo, Europe - South Africa Regional, Europe - Portugal Regional, Europe - Germany Regional, Europe - France Regional, Europe - UK Regional, Europe - Denmark Regional, Europe - Belgium, Zaventem, Europe - Sweden Regional, Europe - Italy Regional, Europe - Czech Republic Regional, Europe - Spain Regional, Europe - Netherlands Regional, Europe - Sweden, Uppsala, Europe - Ukraine Regional, Europe - Switzerland Regional, Europe - Serbia, Belgrade, Europe - Russia Regional, Europe - Germany, Munich, Europe - UK, Lewes, Europe - Serbia Regional, Europe - Israel Regional, Europe - Poland Regional, Europe - Bulgaria Regional, Europe - Italy, Saronno, Europe - Poland, Warsaw, Europe - Hungary, Budapest, Europe - Germany, Langenfeld, Europe - Bulgaria, Sofia, Europe - Belgium Regional, Europe - Spain, Barcelona, Europe - Hungary Regional, Europe - Spain, Madrid, Europe - France, Issy Les Moulineaux, Europe - Israel, Tel Aviv, Europe - Romania, Bucharest, Europe - Czech Republic, Prague, Europe - Romania Regional, Europe - Ukraine, Kiev, Europe - Poland, Krakow, Europe - Scotland, Edinburgh, Europe - Russia, Moscow, Europe - Netherlands, Amsterdam
Job: Site Start Up
Schedule: Full-time
Travel: Yes, 25 % of the Time
Employee Status: Regular
Apply online
Minimalna stručna sprema:
Fakultet
