Clinical Study Manager Associate

Who we are:

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

 What you will do:

The Associate Clinical Study Manager will support the Clinical Study Manager (CSM) on one or more allocated Phase I through IV Clinical Trials that may be local, regional, or global in scope. The Associate Clinical Study Manager will support the overall coordination and management of clinical trials from start up through close out activities.

The Associate Clinical Study Manager responsibilities include, but are not limited to, the following:

• Review and provide follow-up correspondence to study monitor reports.
• Assist in providing study updates to sponsors.
• Assist in tracking and maintenance of project related information.  Set up initial new study in Clinspark and communicate to team accordingly.
• Provide varying support across multiple projects.

What you will bring to the role

• Sense of urgency and ability to be adaptable in a fast-paced and rapidly changing environment, Strong attention to detail, Strong organizational skills, Knowledge and understanding of ICH, GCP, FDA regulations
• Self-motivated and excellent problem-solving skills, strong interpersonal skills, ability to work independently
• Must be able to work effectively with co-workers in a team environment and individually unsupervised.  Must be able to perform duties at a fast pace without errors.

 Your experience:

• Bachelor’s Degree (preferably in the field of Life Sciences or Health) with clinical research experience
• or Associates Degree and an accredited Clinical Research credential, or 5 years of clinical research experience in lieu of a degree.