Job Title: Clinical Trial Manager
Contract: 6 Month
We are seeking a highly motivated individual to join us as a Clinical Trials Manager, Clinical Operations. You will manage all aspects of clinical trial conduct including study start-up, enrollment, study conduct and close-out. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. The position will report to the Program Manager of Clinical Operations.
Responsibilities include but are not limited to:
- Oversees clinical trial conduct including study start-up, enrollment, study conduct and close-out.
- Prepares and reviews study-related and essential clinical study start-up documents (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters). Provides oversight and guidance if some tasks are delegated to a Clinical Trials Specialist.
- Participates in study strategy development, Line Listing Review, and Clinical Study Report preparation, as appropriate.
- Manages the study project plan, including timelines and budget.
- Provides training and manages CRO vendors such as IVRS, Central lab, Imaging.
- Works with CRO to develop and revise study specific plans and detailed timelines, and ensure that transferred obligations and performance expectations are met.
- Further manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files). Creates and implements corrective action plan when performance expectations are not being met.
- Proactively identifies potential study issues/risks and recommends/implements solutions
- BS/BA in nursing, science or health related field with 6+ year's experience of related oncology clinical trial management experience = OR =
- MS/MA in nursing, science or health related field with 4+ year's experience of related oncology clinical trial management experience