Clinical Study Manager

Monmouth Junction, NJ 08852

Posted: 08/20/2019 Industry: Medical/Health Job Number: 49408

Job Description


• Ensures the effective selection, initiation and motivation of clinical study sites
• Plans and drives patient recruitment and retention
• Is responsible for ensuring that the clinical team adhere to the appropriate training needs and performance indicators to ensure 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
• Ensure transparent and proactive communication regarding study progress and trial issues through use of dashboard, trackers and update communication tools
• Oversee 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
• Performs any other duties required to ensure the success of the trial

• Undergraduate degree in a clinical, biological, scientific, or health-related field from an accredited institution; a licensed health care professional (i.e. registered nurse); or equivalent work experience required.
• Read, write and speak fluent English
• 3 – 5 years’ experience in clinical trial management (device experience is a plus)
• Experience with complex trials
• Budget/finance experience on a project level and demonstrates a full understanding of project financials

Meet Your Recruiter

Rebecca Levy

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