Site Manager, Global Clinical Operations - Boise, United States - Idaho State Job Bank

Description

Site Manager, Global Clinical Operations

• Oncology (1 of 2) at J&J Family of Companies in Boise, Idaho, United States Job Description Site Manager, Global Clinical Operations

- Oncology (1 of W Description Johnson & Johnson Innovative Medicine is recruiting for a Site Manager, Global Clinical Operations. This position can be located remotely within the United States. A Site Manager I (SM I) serves as the primary contact point between the Sponsor and the Investigational Site.

A SM I is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure.

Responsibilities may include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities.

The SM I will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols.

May assist in process improvement and training. At Johnson & Johnson Innovative Medicine, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Johnson & Johnson Innovative Medicine. We collaborate with the world for the health of everyone in it.


Key Responsibilities:
+ Acts as primary local company contact for assigned sites for specific trials + May participate in site feasibility and/or pre-trial site assessment visits + Attends/participates in investigator meetings as needed + Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of analytical risk based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits + Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in orde To view full details and how to apply, please login or create a Job Seeker account