US Clinical Operations Manager
At ONWARD we're looking for a US Clinical Operations Manager to join our team.
Full-time · United States of America
US Clinical Operations Manager
As a Clinical Operations Manager, your primary responsibility is to lead and oversee the execution of clinical studies in the United States and Canada. You will work in close collaboration with project teams, including field clinical research associates, field clinical engineers and European project management. In this role, you will manage all aspects of the clinical trial from study start-up through study execution. You will serve as the crucial bridge between healthcare facilities and the company. You will also be responsible for maintaining strong relationships with investigational sites, providing clinical support, and ensuring the proper conduct of studies in strict adherence to Good Clinical Practice (GCP) standards.
Responsibilities
Lead the implementation and coordination of clinical study activities at clinical sites (hospitals) throughout US & Canada. This includes the nurturing of excellent relationships with clinical sites.
Assists with the execution of sponsored studies as well as investigator initiated studies.
Work closely with clinical centers to ensure the seamless enrollment of study subjects and the collection of high-quality data in accordance with GCP requirements.
Play a key role in the development of the different study-related materials, SOP’s and documentation.
Establish and manage a team of clinical team members. Foster a strong team spirit, provide training, and offer coaching to ensure optimal performance.
Manages all site activity from site selection, contracting, IRB’s through execution.
Manages field monitoring, assigning monitoring visits and approving monitoring reports.
Creates and Maintains the study eTMF.
Works closely with DM for site remote monitoring of database.
Handles site deviations and CAPA’s if needed.
Leads any necessary protocol amendments with IRB, sites and field team.
Undertake any other responsibilities as required to support the needs of the clinical organization.
Holds a Bachelor degree in science, or relevant subject matter.
Accumulate 5+ years of experience as a clinical project manager or in an equivalent role supporting clinical trials for Class III medical devices under the rigorous conditions of Good Clinical Practice (GCP).
Demonstrate the capability to work effectively with US and Canadian clinical centers.
Display the willingness and ability to travel as needed to clinical study sites, ensuring effective oversight and support.
Maintain strong oral and written proficiency in English.
Exhibit strong interpersonal skills and the ability to interact effectively with internal and external stakeholders, including CROs, Key Opinion Leaders, and all staff members at the clinical sites.
Thrive in an innovative, fast-paced, and performance-driven organizational environment, demonstrating a results-oriented approach.
Maintains a strong ethical foundation, positive outlook, and a pragmatic attitude.
ONWARD CODE Representation: Embody the core values of ONWARD, including being empowered, committed, pragmatic, innovative, open, trusting, collaborative, and passionate.
Supervision
As the Clinical Operations Manager, you will oversee and manage clinical research associates and clinical trial associates.
Do you want to join our team as our new US Clinical Operations Manager? Then we'd love to hear about you!