||Sr. Clinical Affairs Specialist
The incumbent will be responsible for managing the clinical affairs department, including day to day activities, external vendor management, and overall corporate clinical strategy while ensuring all clinical activities are being conducted in compliance with
NxStage Standard Operating Procedures and Good Clinical Practice (GCP). This position will report to the Vice President, Regulatory and Clinical Affairs.
• Manage and oversee consultants and contractors (e.g. CRO’s, statisticians, etc.) to ensure all studies and clinical documentation is executed to schedule
• Manage escalation of study related issues and communicated as appropriate with management
• Develop and manage the clinical research budget and ensure studies and Clinical Evaluation Reports are conducted within budgetary constraints
• Ensure complete, accurate and up to date project central files are maintained.
• Provide clinical input to the product development team, as appropriate.
• Review advertisement and promotional materials from a clinical perspective to ensure compliance with clinical claims
• Establish and maintain a relationship with all physician investigators and Scientific Advisory Board and European Medical Board members.
• Author, review and approve various study related documents and plans.
• Key participant and contributor to the design of clinical trials, assisting Regulatory Affairs in preparing and submitting Investigational Device Exemption (IDEs), to the US FDA or other Regulatory Authorities and submitting and obtaining approvals from IRBs
and Ethics Boards as needed.
• Provides periodic status reports regarding study timelines, budget issues, etc to management as requested
• Participate on cross-functional developmental teams.
• Interface with FDA personnel and Competent Authorities on clinical issues.
• Other duties as assigned.
||Education & Qualifications:
• B.S. or B.A. with experience with execution of medical device clinical trials
• 7+ years’ experience in Clinical Affairs in the medical device industry including both domestic and international
• Conversance with IDE, IRB, Informed Consent, CFR, Investigator Agreement, budget, data collection, data storage, data management, data analysis, and all associated elements of a clinical trial
• Detailed regulatory knowledge (FDA/21CFR Part 820; EN 540/GCP; ICH; 510k, Medical Device Directive) in particular regarding Clinical Evaluation Reports per MEDDEV 2.7.1 Revision 4
• Experience interacting with FDA and international bodies regarding clinical matters
• Solid organizational skills
• Demonstrable project and people managerial skills such as:
• Administer successful programs within a timeline and within budget
• Effective communication on superior, peer, and subordinate level
• Ability to hire quality professionals
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