Position Summary: Responsible for planning, executing, and managing the global Clinical Affairs activities including initiating and monitoring clinical trials, developing, overseeing and monitoring post-marketing studies and supporting pre-clinical studies as necessary.
Position essential duties and responsibilities: Include the following; other duties may be assigned.
 Oversees clinical operations and data collection function and develops the infrastructure to support clinical trials; team participation in planning for and supporting submissions and interactions with the FDA.
 Establish and approve methods for design and implementation of clinical protocols, data collection systems, and final reports. Plan, write, and execute clinical studies in conjunction with Marketing and R&D Departments as well as medical experts.
 Oversee CRO and/or clinical data processing, including form design, data tracking, data entry codes, and document processing. Plan and review data analysis and determine the final presentation of results.
 With Regulatory Affairs, support timely submission of IDE Annual Reports with all divisions of CDRH. Review and analyze new and evolving ICH guidelines and EU regulations and assist appropriate areas of company to support the QMS.
 Primary contact for interaction with FDA and other regulatory agencies relative to agency inspections, compliance documentation, and information related to clinical trial activity.
 Team participation in providing direction, coordination, and evaluation of outside clinical consultants.
Job Complexity: Work on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Requires in-depth knowledge of functional area, business strategies and company goals.
Essential experience and skills:
 BS/BA degree and five to ten years related experience in medical device, biotechnology and/or pharmaceutical industries; or equivalent combination of education and experience. At least five years of overall senior business experience required.
 Excellent and highly professional written and oral communication skills.
 Computer proficient (Microsoft Word, Excel, PowerPoint, Data base application, and Internet searching and navigation).
 Thorough understanding of clinical development, clinical research, and regulatory requirements, especially GCPs.
 Strong ability to manage multiple complex projects.
 Proven capability to understand company needs, build strong alliances/networks, utilize innovative approaches to improve processes and provide inspirational leadership.
 Self-directed, self-motivated and detail oriented.
 Excellent interpersonal skills. Ability to travel.
Reporting to this position: Initially none but may evolve as clinical trials get underway and internal clinical study support is required.