Position Summary

The Associate Director, Clinical Research is responsible for defining the clinical research plans and management of all clinical studies. The Assoc Director will manage operational and logistical tasks of clinical development to ensure efficient organization and execution of research within established budgets and timelines, ensuring all activities occur in compliance with the appropriate regulations, including FDA regulations, IDE, 510(k) guidelines, etc. The Assoc Director will coordinate the efforts of internal and external resources to ensure patient recruitment, trial site selection, plan optimization and execution of data acquisition.

A.

Knowledge:

1

 Minimum Educationl Requirements

Bachelor’s Degree Required.  Masters  preferred.  CCRC and CCRA Certification

2

Minimum Experience Requirements

 7+ years clinical research trial experience. Experience with all aspects of     management of large clinical trials from inception to completion.  Strong interest in the orthopedic industry.

3

Minimum Skill Requirements

Excellent interpersonal and communication skills. Management, leadership, and organizational ability. Ability to prioritize and manage the workload, and, as required, be able to manage shifting priorities based on critical deadlines so that production needs are always met. Ability to develop and give presentations on technical and regulatory topics. Ability to train/mentor associates. Ability to effectively deal with a variety of conflicting issues and diplomatically solve those issues. Ability to read, analyze, and interpret complex technical documents and manuals. Ability to define problems, collect data, establish facts, and draw valid conclusions. Highly organized and detail oriented. Ability to handle multiple tasks concurrently. Excellent time management skills.

4

Equipment or Machines Used

PC, Microsoft Office software suite, general office equipment.

B.       Principal Duties

• Leads prospective and retrospective clinical research initiatives.
• Manage clinical research and operations including design and initiation of clinical trials to optimize tactical and clinical value through U.S. site selection and data portability.
• Coordinate and oversee clinical trials to support regulatory submissions (PMA, IDE, 510(k)), as well as post-market clinical trials and clinical preference evaluations.
• Clinical study project management including:

·         Case Report Form (CRF) Development

·         Site Management and Study Monitoring

·         IRB Approvals and Management

·         Data Management

·         Investigator/Coordinator Meetings

·         Site Qualification Visits

·         Site Initiation Visits

·         Training the Clinical Sites to the study protocol

·         Site Close Out Visits

• Work with external sites to ensure expedient patient recruitment in conjunction with CRO.
• Participate in defining clinical application of Medacta products and contribute in the development of post-market clinical studies
• Author and/or work with others to develop publications based on the results of the clinical trials.
• Provide updates and status reports to senior management on a regular basis; report on performance against plan.
• Manage the budget for clinical research. Ensure overall operation is within the approved budget and timeline.
• Develop and implement SOPs for clinical research/trials and related activities
• Ensure compliance with all applicable regulatory standards related to clinical research/trials and interactions with physicians
• Develop and maintain professional relationships with academic and community-based physicians, clinicians and investigators to assure good clinical input to the  product development process, marketing, and field sales force
• Interface with departments within and outside of the company Accounting, R&D, Regulatory Affairs, Product Development and Marketing.
• Manage outside partners/service providers
• Represent the company at major annual conferences
• Travel requirement up to 40%.

C.        Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this position. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.