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Miles
Km80.5

Director Clinical Compliance

Clinical Dynamix, Inc.

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Location: New England area or Boulder CO, MA Posted Date: 4/8/2013 Position Type: Full time Job Code: 1234 Required Education: Masters Degree Areas of Expertise Desired: Clinical Research
Medical Affairs
Quality Assurance

Description

Direct all aspects of the company's Global Clinical Compliance Assurance Function so as to provide Compliance and Quality oversight of GCP and Clinical Trial Management. The Director will provide scientific and practical leadership to compliance strategy and assist the Vice President in determining policy and strategic planning that pertains to Clinical Compliance. Will integrate best practice methodology into the overall compliance plan by the oversight and coordination of outside resources, the review and validation of deliverables, and the establishment of processes to ensure that work product within the clinical functions are performed consistently while controlling risk. Will be responsible for organization development, identifying and executing resource requirement; Has management responsibility over both internal and external resources. Will be responsible for driving continuous improvement in all processes associated with the function.
Principal Accountabilities
•   Drive Compliance and Quality Assurance programs based on relevant regulations and guidance documents e.g. ICH-GCP, US CFR & EU Clinical trial directive and associated local regulations.
•   Establish internal and external risk-based audit programs to assess capability, efficiency, quality, and compliance of clinical systems, processes, and procedures to ultimately ensure accuracy and quality of scientific data generated through clinical programs and submitted to peer-reviewed journals or to regulatory agencies.
•   May conduct clinical audits directly.
•   May help coordinate regulatory agency and third party inspections in GCP area.
•   May conducts investigations to ensure conformance to regulations and company standard operating procedures.
•   May document audit observations and makes recommendations for corrective action.
•   May create and maintain clinical quality assurance databases, reports, and files.
•   May act as an advisor on clinical quality assurance protocol amendments and/or biological licensing agreements. Non-manufacturing clinical focus.
Manage CQA departmental budget

Requirements

Requirements
•   Bachelor’s degree or equivalent preferably in scientific/Healthcare field
•   MBA, MS or other technical graduate degree preferred
•   8+ years experience in Quality assurance and GCP Compliance or advanced degree and 6 years relevant experience
•   Sound awareness and understanding of the medical device or pharmaceutical business, especially with regards to global Quality, Compliance & regulatory requirements
•   Demonstrated success in auditing & quality improvement processes
•   Strong organizational and management skills \, including 3+ years Clinical QA management experience.
•   Demonstrated ability to work effectively within global cross-functional teams.
•   Demonstrated ability to influence global cross-functional team members without direct-reporting relationships.
•   Demonstrated ability to effectively facilitate large technically complex meetings/sessions.
•   Detail-oriented.
•   Clear oral and written skills.
Medical Affairs or R&D Business process experience preferred
LOCATION:  Position can be located in Mass, CT or CO offices
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