Clinical Trial Manager IVDR (FSP)

Clinical Trial Managers at Parexel FSP play a pivotal role in supporting, coordinating, and delivering our clients’ regional and global clinical trials. This includes full involvement in study start-up, maintenance, and close-out, as well as vendor management and CRA oversight.

If you’re a CTM 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.

Our study managers each 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

Work on Phase I, II, or III or IV, regional or global trials.Work on innovative IVDR trialsStart-up planning and vendor management responsibilitiesPlay a key role in handling high profile and sensitive operations, taking a study to the next level.Highly respected top 50 Pharma sponsor

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

Clinical Trial Managers at Parexel FSP

Due to the nature of our projects and sponsors, we hire more experienced CTM’s, who have already spent several years in the role, with study start-up and vendor involvement.

You’ll report to a Senior Project Leader but will have considerable operational freedom and plenty of sponsor contact. Study managers who join us often say they particularly like the agility and pace here. We’re all about making the right decisions fast.

Our CTM's each work for a single sponsor. You’d typically manage between one and three studies, depending on size and complexity. You could also be part of a team of study managers on a major trial, potentially in the lead role if you’re more experienced.

Working with Parexel FSP 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.

As we mentioned, the study manager role here is more influential than the norm. Trial start-up, maintenance and close out. Vendor management. Overseeing CRAs and studies. Chairing meetings. Coordinating submissions. All will be within your scope.

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 are looking for in the IVDR CTM

Precise requirements for each study manager role vary from sponsor to sponsor, but generally we look for people with at least 5 years’ direct experience as a study manager.

Additionally, you’ll need: -

Past exposure to trial start-up, maintenance, and close activities.Experience assisting with retrieval of relevant information/guidance from the RA, EC and regulation (in collaboration with Regulatory)Experience dealing with the collection of local deliverables required for the applicationExperience assisting with the review of the EC submission packageExperience assessing the impact for site start-up activities and timelinesExperience developing communication to sites, as neededExperience assisting in triaging EC review comments received by the applicant

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