Global Study Start Up Manager / SSU Manager - Remote - FSP - Register Your Interest

REGISTER YOUR INTEREST FOR AN UPCOMING OPPORTUNITY

Parexel FSP is starting to recruit in advance of an upcoming need for an experienced Global Study Start Up Manager/ Leader to join one of our key sponsors in the UK.

In this role you will be responsible for defining, developing and delivering the global start up project strategy, you’ll be assigned to one or more interventional studies in one or more therapy areas such as oncology, vaccines, internal medicine, rare disease or inflammation and immunology.

Typically your responsibility ends when all investigative sites are activated and ready to enroll participants, however this can extend further into the participant recruitment period to specifically deliver the implementation of protocol amendments across active sites for selected studies.

Some specifics about this advertised role

• Partner with country / site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan.
• Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions to align country and site activities to form a robust start-up strategy and site activation plan.
• Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study.
• Act as a key point of escalations for site activation related issues raised by country level start up roles.
• Responsible for the completeness and quality of site activation timeline plans for every site from investigator initiation package sent for first site in study, to site activation complete for last site in study.

Who are Parexel

Parexel supports clinical studies across the full range of 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.

You’ll be an influential member of the wider team.

What we are looking for in this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first.

That to us is working with heart.

Here are a few requirements specific to this advertised role.

• Bachelor’s Degree or equivalent and 5+ years of experience in clinical trials
• Extensive global start up clinical trial/study management experience is essential
• Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization.
• Working knowledge of clinical trial functions, including clinical operations, regulatory and drug safety.
• Ability to prioritize and manage multiple tasks simultaneously.