Study Start-Up Specialist
Belgium, Remote Additional Locations: Wavre, Walloon Brabant, Belgium Job ID R0000017199 Category Clinical TrialsAbout this Role
Parexel are searching for an experienced Study Start Up Specialist, to join us in either the Netherlands or Belgium.
As the Study Start Up Specialist you’ll be responsible for supporting site start-up activities, including collection and review of essential documents, and reviewing and approving Informed Consent Forms (ICFs) for ethics committee submissions for assigned clinical sites, across the Benelux region.
If you’re a SSU professional with experience of these activities, we can offer you a stellar future. One that will not only involve you in internationally significant developments for top name sponsors, but also equip you for project management and other senior level roles.
You will work with one sponsor exclusively, in a truly collaborative partnership. We offer exceptional financial rewards, training, and development. Expect exciting professional challenges, but with a healthy work/life balance.
Some specifics about this advertised role
- 100% Home-based
- Accountable for site start-up for assigned clinical sites.
- Serves as site’s primary point of contact for start-up, resolving site queries and assisting sites with ethics committee submissions.
- Sends start-up packets.
- Reviews and approves ICFs pre- and post-ethics committee submission.
- Collects, reviews, approves, and tracks essential documents, and reviews and approves ICFs in accordance with sponsor processes and timelines.
- Assists in resolution of site queries for assigned clinical sites.
- Provides regular updates and escalates site issues to Manager, SSU.
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Not your therapeutic area? Not quite your role? Don’t worry. We’ve other study management opportunities explore current openings, visit https://jobs.parexel.com/functional-service-provider
SSU Specialist at Parexel
Due to the nature of our projects and sponsors, we hire more experienced professionals, who have already spent several years in the role, with study start-up and vendor involvement.
You’ll report to a Senior FSP Operations Manager but will have considerable operational freedom and plenty of sponsor contact. Managers who join us often say they particularly like the agility and pace here. We’re all about making the right decisions fast.
Working with Parexel means you’ll be directed by the sponsor, while remaining part of our worldwide team. We’ll partner with your sponsor to plan your training and career progression. Promotion can come at any time, and not just at the end of an assignment.
In fact, as your experience builds, your role will develop naturally towards project management. Equally, study management is a technical career path here in its own right. There are fantastic opportunities to develop your experience and skills.
Just finally, we value work-life balance. We aim to keep regular hours and maintain our lives outside the office. We’ll value your welfare just as highly as that of our patients. And our managers will listen to, and act on, any concerns.
What we look for in our SSU Specialists.
Precise requirements for each role vary from sponsor to sponsor, but generally we look for people with at least 3 years’ direct experience.
Additionally, you’ll need: -
- Minimum of 3 years of relevant clinical trial experience.
- Thorough knowledge of clinical start-up process and requirements required.
- Knowledge of CFR and ICH/GCP requirements is required.
- Requires effective organizational and time management skills.
- Able to multi-task under limited direction and on own initiative.
- Strong communication and inter-personal skills.
- Highly responsive and proactive, a team player.
- Oncology clinical research experience, preferred.
- Dutch and English language skills are essential.
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