Description

CytoSorbents Corporation, a leader in the treatment of life-threatening conditions in the ICU and cardiac surgery using blood purification, is seeking a motivated Senior Clinical Study Manager to manage clinical study sites for its US investigational device exemption (IDE) application. You will be working in a dynamic, innovative, entrepreneurial spirited environment where together we will transform cardiac surgery. Come join us in saving lives!

• Manage clinical study sites for its US investigational device exemption (IDE) application.
• Ensures the effective selection, initiation and motivation of clinical study sites
• Plans and drives patient recruitment and retention
• Ensures that the clinical team adheres to the appropriate training needs and performance indicators to guarantee the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP, protocol and client requirements
• Takes the initiative to move the project/program forward and leads in country and global projects where applicable
• Is customer focused on both internal and external customers
• Leads and manages clinical vendors with focus on deliverables
• Supports Clinical Affairs/Clinical Operations Management in the development and review of the protocol/study design, case report forms, informed consent forms and other documents
• Ensures transparent and proactive communication regarding study progress and trial issues through use of dashboard, trackers and update communication tools
• Oversees the development and approval of clinical study execution plans and tools
• Drives the successful activation of trial sites according to time, quality/scope and budget parameters
• May serve as initial point of contact for all clinical management and monitoring issues, vendors and other functional areas, escalating as required
• Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member
• Works with the Data Management team to identify data related issues and risks to clinical activities; assists in the development of mitigation plans to minimize risk
• Escalates issues and provides escalation path for the team 
• Be available to travel (around 20%) to New Jersey and other locations
• Performs any other duties required to ensure the success of the trial

Requirements

• Bachelor’s or higher degree in health sciences area along with 10 years experience in clinical trial management from a sponsor's side in medical device, biotech or medtech companies
• Previous experience as a study manager in pivotal FDA trials in acute cardiovascular medicine
• Budget/finance experience on a project level and full understanding of project financials
• Covid-19 vaccination is required

Candidates must be legally authorized to work in the US and will not require sponsorship now or in the future.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected under applicable law.