Manager Study Start-up

The Manager, Study Start Up at Parexel plays a pivotal role in Site Start-Up activities and including coordination, management, and oversight of Site Start-Up for two or more clinical studies. This position includes direct management of staff within the Study Start-Up team.

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.

Our Manager, SSU 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 2 or more clinical studies.
• Serves as primary point of contact (POC) and escalation for Site Start-Up on assigned clinical studies.
• Conducts the Start-Up Kick Off Meeting the Clinical Study Team and other key stakeholders.
• Conducts weekly Start-Up meetings with the Clinical Study Team and other key stakeholders as necessary.
• Set goals and provide oversight, guidance, mentoring, feedback and performance reviews.
• Manage team workload efficiently across studies to ensure deliverables are met.
• Perform hiring and training activities as needed.

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

Manager, Study Start Up at Parexel

Due to the nature of our projects and sponsors, we hire more experienced 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. 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 the Managers, SSU.

Precise requirements for each role vary from sponsor to sponsor, but generally we look for people with at least 6 years’ direct experience.

Additionally, you’ll need: -

• Experience managing teams (direct or dotted line reporting), preferred.
• Thorough knowledge of clinical Start-Up process and requirements required.
• Thorough knowledge of CFR and ICH/GCP requirements is required.
• Requires effective organizational and time management skills.
• Experience with CRO oversight preferred.
• Experience with Oncology trials preferred.