Clinical Study Manager Job at Worldwide Clinical Trials
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 Clinical Study Manager (CSM) will manage eight to ten (8-10) Phase I Clinical Trials that may be local, or regional in scope. Clinical Study Manager (CSM) is responsible for the overall coordination and management of clinical trials from start-up through closeout activities. Directs the technical, financial, and operational aspects of the projects to secure the successful completion of clinical trials.
The Clinical Study Manager responsibilities include, but are not limited to, the following:
- Lead core project team members and facilitate their ability to lead extended/complete project team
- Lead cross-unit coordination both internal and external, inclusive of sub-contractors
- Define and manage project resource needs in conjunction with functional heads and establish contingency plans for key resources
- Works with functional area leads to identify and evaluate fundamental project requirements, interpret data on complex issues, is responsible for contingency planning and implementation of rescue strategy where needed and ensure solutions are implemented and ensure that all staff allocated to assigned projects are trained on the study protocol and all other study-related processes, adhere to professional standards and to SOPs as well as current Good Clinical Practice (GCP) and applicable local regulations
What you will bring to the role
- Some knowledge and skills in performing technical and laboratory procedures
- Experience performing vital signs, ECGs, and laboratory procedures
- 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:
- Required: University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) or equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities
Preferred: Minimum of five (5) years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical project
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