Director - Clinical Research - Medacta USA - Chicago

Job description
The Director of Clinical Research is responsible for defining the clinical research strategy and management of all clinical studies being conducted by Medacta USA and in partnership with Medacta International. The 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 Director will coordinate the efforts of internal and external resources to ensure patient recruitment, trial site selection, plan optimization and execution of data acquisition.

Main duties and responsibilities:

- Set strategic direction and 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 Medacta 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 Medacta’s product development process, marketing, and field sales force.

- Interface with departments within and outside of Medacta USA, including Medacta International Clinical Research Department, Accounting, R&D, Regulatory Affairs, Product Development and Marketing.

- Manage outside partners/service providers

- Represent the company at major annual conferences.
Desired Skills and Experience
- 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

- Demonstrate excellent communication skills (verbal and written).

- 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.

- Strong experience with Microsoft Office (Excel, Word, Powerpoint)

- Bachelor’s Degree Required. Masters or MD/PhD preferred

- CCRC and CCRA Certification

- Experience with all aspects of management of large clinical trials from inception to completion

- Knowledge of FDA regulations and experience with IDE Trials

- Strong interest in the orthopedic industry; experience with arthroplasty/spine clinical studies

Medacta offers a comprehensive and highly competitive package of benefits that includes helping our employees maintain a good work/life balance.

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