Clinical Trial Leader

5 months ago

Remote, United Kingdom Parexel Full time

United Kingdom, Remote

**Job ID** R0000021572

**Category** Clinical Trials

**ABOUT THIS ROLE**:
Clinical Trial Leaders (CTL) 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/CPM 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 Trial Leads 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**
- 100% Home-based.
- Work on Phase I, II, or III or IV, regional or global trials.
- Accountable for the accurate planning and operational feasibility of trial timelines; and oversight of trial preparation to ensure trial team members are aligned and on track. Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring).
- Oversees outsourcing of vendor services in conjunction with other functions. Supports identification of vendors, vendor selection and development of vendor scope of work.
- Works with functional partners to ensure that all required trial processes are in place to meet trial delivery milestones (e.g. clinical quality monitoring, safety monitoring and reporting, investigational medicinal product, trial budget, site monitoring).
- Maintain oversight of outsourcing of vendor services (including Central Lab) in conjunction with other functions.
- Highly respected top 50 Pharma sponsor.

**Clinical Trial Leads at Parexel FSP**

Due to the nature of our projects and sponsors, we hire more experienced Trial Managers, 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. CTM’s who join us often say they particularly like the agility and pace here. We’re all about making the right decisions fast.

Our CTL’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.

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 CTL’s**

Precise requirements for each CTL role vary from sponsor to sponsor, but generally we look for people with at least 4 years’ direct experience as a study manager.

Additionally, you’ll need:
- Strong clinical trial project management experience, minimum of 4 years global clinical trial/project oversight experience.
- In depth understanding of project management with an emphasis on team work, to promote high performance teams.
- Experience in either Oncology, CNS, Immunology or Vaccines
- Extensive experience in clinical trial project management across international trials
- Experience of following milestones for the region with the local team.
- Experience in Phase I-III trials and CRO management.
- Experience of coordinating the EC submission in participating countries.

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