Clinical Study Lead/Global Trial Manager – FSP
When our values align, there’s no limit to what we can achieve. At Parexel, we all share the same goal – to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special – a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.
REGISTER YOUR INTEREST IN AN UPCOMING ROLE.
Parexel is beginning to search for an experienced Clinical Trial Manager to join one of our key sponsors in the UK as a Clinical Study Leader.
In this role you are accountable for the support of global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out.
Some specifics about this advertised role
- Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
- Provides operational input into protocol development
- Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
- Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
- Supports compliance with the clinical trial registry requirements.
- Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors.
- Provides input into baseline budget development and management.
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 and minimum 6 years of relevant global trial management experience.
- Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS.
- Knowledge of ICH GCP and relevant regulatory guidelines/directives.
- Demonstrated interpersonal & leadership skills.
- Ability to understand and implement the strategic direction and guidance for respective clinical studies.
- Effective communication skills via verbal, written and presentation abilities.