Parexel is beginning to search for an experienced Senior Clinical Trial Administrator to join one of our key sponsors in the Clinical Trial Specialist.
In this role you will provide technical and administrative support to the clinical study teams responsible for clinical trial execution.
Some Specifics About This Advertised Role
* Support moderately complex clinical study activities in support of the Clinical Trial Manager.
* Work closely with the clinical trial team to ensure trial activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's.
* May assist with vendor oversight and management with guidance.
* Identify issues in a timely manner and escalate to management as appropriate.
* Oversight of TMF
* May complete monitoring visit report review and perform co-monitoring or monitoring oversight visits.
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.
* At least 2 years of experience (3yrs preferred) in clinical studies (Pharmaceutical Industry Experience Preferred).
* Previous site monitoring or study coordinator experience is preferred.
* Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures.
* Understanding of study phases and general knowledge of how they apply to clinical development.
* Demonstrated ability to work independently and in a team environment.
* Working knowledge of electronic Systems including Trial Master File, CTMS, etc. (e.g., Veeva Vault, Smartsheet, SharePoint, etc.).
* Knowledge of the principles and practices of computer applications in database management.
* Strong verbal and written communication skills required.
* 10% - 20% travel may be required.