Job Description

****Relocation Assistance Available****

Job Summary

The Clinical Site Manager is responsible for the overall management of the life of a clinical trial, overseeing the work of Study Coordinators and Clinical Research Nurses to ensure efficiency and success of the applicable trial.

Key Responsibilities

Team Leadership and Coordination

• Supervise and mentor Study Coordinators and Clinical Research Nurses
• Provide training and ensure all staff is familiar with the study protocol, ethical guidelines, and safety requirements
• Foster effective communication among all stakeholders

Clinical Responsibilities

• Be the expert on assigned trials; understanding and implementing the protocol.
• Create study timelines and execution planning (IP delivery, lab kits, etc)
• Involved in all study planning - monitor communications, attending IM + SIV, approving source creation (paper and electronic)
• Be able to act as the backup to the coordinators
• Serve as primary escalation and contact for resolution of issues that arise throughout trial for both internal and external teams

Regulatory Responsibilities

• Managing internal greenlight process - ensuring all training and delegations are appropriately signed and completed, collaborating with regulatory
• Maintain all appropriate documentation throughout the trial
• Ensure all invoiceables are captured correctly for studies
• Work with QA to evaluate root-cause analysis of CAPA’s

Educational Responsibilities

• Collaborate with new clinical staff to ensure adequate development of CRN’s/SC’s
• Be a resource and educator for all coordinators

Qualifications

• Strong team leadership and management skills
• Strong verbal and written communication skills
• Strong interpersonal and customer service skills
• Strong organizational skills and attention to detail
• Strong time management skills with a proven ability to meet deadlines
• Strong analytical and problem-solving skills
• Ability to prioritize tasks and to delegate them when appropriate
• Ability to function well in a high-paced environment

Education and Experience

• Bachelor's or Associates degree in health or science related field required
• 3-5 years of experience in clinical research, with at least 2 years in a managerial role overseeing clinical studies or trials

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