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Study Start-Up Specialist (FSP)Job ID 83701BR Italy - Any Region - Home Based
Our key oncology biotech sponsor is building a brand new SSU function in Europe from the ground up, and we need SSU professionals to help them across the EU.
Some specifics about this advertised role
- A rare opportunity to help build an SSU function
- Dedicated to one client.
- Contribute to SSU processes to adapt them to the country requirements related to the new regulation
- Forecasts and tracks metrics and progress of site start-up for assigned clinical sites, ensuring all sites are greenlit on time per study start-up timelines.
- Work with world class technology.
- Collects, reviews, approves, and tracks essential documents, and reviews and approves ICFs in accordance with Client processes and timelines
Study start up at Parexel FSP
Parexel FSP supports clinical studies across the full range of oncology and non-oncology therapeutic areas, and we have longstanding partnerships with a vast client base.
We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.
On a human level, if you’re a SSU professional with a passion for a particular therapeutic area, we’ll do our best to accommodate you. Or equally, we can help you broaden your experience.
You’ll be an influential member of your team really working with the sponsor to help develop the function.
As well as learning by osmosis from industry-leading professionals, you’ll gain world class training from Parexel and from our sponsors too.
And you’ll be able to share knowledge and ideas with a global community of clinical operations, biometrics, regulatory, medical writing, and medical affairs specialists.
As you close one site, there’ll be many more opportunities open to you, at the top of your profession.
We value work-life balance. We aim to keep regular hours and an emphasis on life outside the office. We’ll value your welfare just as highly as that of our patients. Our managers will listen to, and act on, any concerns.
QualificationsWhat we look for in Associate SSU Specialists
- Bachelor’s degree in nursing, Life Sciences or Medical Sciences or equivalent work experience required.
- experience on ICF country level creation, country customization, knowing the requirements and guidelines per country.
- Experience submitting to ECs. SSU team will be involved on the package preparation and submission execution to CEC/LEC/ Part II and local specific authorities.
- Effective time management, organizational and interpersonal skills & problem-solving skills, with the ability to multi-task and prioritise.
Not quite the role for you?
Don’t worry we need experienced professionals for different locations, sponsors, and therapeutic areas, and at entry, mid and senior levels.
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