ConforMIS, Inc., located in Burlington, MA is a dynamic, growing company delivering a breakthrough approach to orthopedics and sports medicine. ConforMIS provides image-derived, minimally-invasive implant and instrumentation systems designed to conform to the unique anatomy of each patient and to dramatically simplify orthopedic and sports medicine surgery.

POSITION TITLE: Clinical Trial Manager/Sr. Manager/Director (depending on experience)

REPORTS TO: Sr. Vice President, Regulatory and Clinical Affairs

POSITION STATUS: Exempt

Responsibilities:

1. Manage the conduct of current and planned orthopedic clinical trials, including investigator recruitment, managing data flow, clinical quality assurance, data review, etc.
2. Assist in the development and preparation of clinical protocols, with input from medical and technical staff;
3. Develop appropriate case report forms and other study related documents;
4. Act as liaison with IRBs, Ethics Committees, etc. to assure timely compliance with all requirements, approval of new investigational sites, etc.;
5. Act as liaison with outside data management service;
6. Prepare reports, slides, presentation of clinical data as needed
7. Act as liaison with, and supervise, CRO in Europe

Qualifications:

1. RN or BA/BS in an appropriate field of study;
2. A minimum of 5 years of clinical research experience (10+ preferred) that includes administrative/site management responsibility;
3. A “hands on” attitude
4. Experience in small company environment a plus
5. Strong computer skills (Microsoft Office)
6. Basic understanding of statistical principles;
7. Strong familiarity with GCP and ICH Guidelines for clinical trials;
8. Ability to work independently in a small company environment;
9. Orthopedic background a strong plus

Please submit resume to:

hr@conformis.com