Clinical Trial Manager/Project Manager (US-East-Coast Remote)

Responsibilities The Clinical Trial Manager (CTM) is accountable for achieving successful delivery of clinical activities at the project level by meeting internal and external contractually agreed client and regulatory requirements according to time, quality/scope and budget constraints.

The Clinical Trial Manager (CTM) leads and directs cross functional teams and understands/manages client expectations. In addition, the Clinical Trial Manager (CTM) proactively identifies, resolves/mitigates and escalates risks and/or issues.

Depending on the business unit the descripted accountabilities may or may not apply.

Daily Management of a Trials POC for sponsor, sites and CRAs Study Tracking and Monitoring trip report review Provides Project Oversight and Leadership for Clinical Deliverables: Leads and manages the start-up and clinical teams Plans and leads execution of the day to day activities for the monitoring of a clinical study and communicates consistently with the clinical team providing project objectives, expectations and status updates.

Works with the team to set priorities Takes the initiative to make things happen and leads and supports the relevant staff ( this may include but is not limited by Country Start Up Specialist (CSS), Global Regulatory Affairs Lead (GRAL), Local Regulatory Affairs Lead (LRAL) and In-House Clinical Research Associate (IHCRA)) to ensure the successful activation of trial sites according to time, quality/scope and budget parameters Motivates the clinical team Ensures effective communication plans are place for the clinical team Ensures effective escalation plans are in place for the clinical team Works with the Project Manager (PM) to facilitate cross functional team and sponsor communication for proactive, study-wide problem solving regarding study progress and trial issues during the study Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member Oversees the GRAL, LRAL and IHCRA to e