Clinical Site Manager (CSM)
The CSM supports multiple activities for the conduct of clinical research studies, operations and special projects in compliance with applicable regulatory standards, IRB/EC policies and procedures and Intact Vascular internal requirements. This position works with minimal supervision and directly with study management and the study team.
- Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.
- May assist in preparation of sections of the Investigational Plan, study materials and/or training.
- Will interface with, and ensure training of investigators, site staff, and assigned Intact Vascular staff.
- Assist in site initiation (e.g. start-up document preparation, distribution, receipt, and review) and site closeout activities.
- Responsible for coordinating field activities with clinical site needs to ensure enrollment and study execution.
- Assist in follow-up and resolution of site issues.
- Assist in review of adverse event information.
- Assist in device allocation, reconciliation and compliance, review, and conclusion of device complaints.
- Assist in preparation of annual, interim and final reports and presentations.
- May assist with oversight of activities performed by Contract Research Organizations (e.g. CROs, core labs).
- Able to refer to Standard Operating Procedures (SOPs) for guidance on everyday study tasks.
- Contribute to ongoing SOP development and review.
- Participate in training to enhance knowledge base.
The successful candidate must have / be:
- Strong verbal and written communication skills, technical and problem solving skills
- Able to read, analyze and interpret general business documents, technical procedures, and standard operating procedures
- Able to work effectively, independently and on cross-functional teams
- Able to write reports, business correspondence and procedure manuals effectively
- Able to frequently use general knowledge of industry regulations, practices, techniques, and standards
- Develop solutions to a variety of problems of moderate scope and complexity
- Able to refer to policies and regulations for guidance
The above statements are intended to describe the general level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities.
- Education Level: Bachelor’s Degree and 1+ year of experience in clinical / clinical research setting.
- Knowledge of ICH and GCP Guidelines
Strong computer literacy with Microsoft Office
- Hands-on team player with the ability to work in a fast paced, dynamic start-up environment.
- Understanding of Clinical Operations
- Experience working with small cross-function product/process development teams.
- Able to generate and communicate project strategies and scenario plans to team members, management, board members, etc.
- Ability to work independently
- Environmental Situation
- General Office Environment
- Medical Device Research Manufacturing Environment
- International and Domestic Travel
- Physical Functionality
- Varying work schedule
- Prolonged periods of standing, sitting and walking
- Up to 80% overnight travel by automobile, aircraft and train
- Occasional weekend travel