Clinical Project Manager

“A Great Day in the O.R.” is our promise to the hospitals, patients and surgeons that use our products. We need people who can guarantee this takes place every day. If you provide excellent internal and external customer service and are goal- and team-oriented, you will experience a great day in the workplace at Exactech while also contributing to our long-term vision.

Our hiring process starts when you submit your cover letter and resume to human.resources@exac.com. You will receive notification that confirms Exactech’s receipt of your resume. If you are among the more qualified candidates, a Human Resources representative and/or the hiring manager will contact you to discuss the position.

Team

Clinical Research/Regulatory

Minimum Requirements for Fulfilling Team Role

Education

Relevant BS/BA or equivalent required, MS or PhD will be considered.

Experience

• Minimum 2 – 3 years clinical research experience required
• Project management experience preferred
• Understanding of IDE, PMA, 510(k), and Good Clinical Practice (GCP) desired
• Strong knowledge / experience of study monitoring process desired
• Orthopaedic background preferred
• Firm understanding of biostatistical concepts required

Other

• Demonstrated competence in working independently and managing multiple projects
• Strong interpersonal skills; must build lasting relationships with co-workers, investigators and investigator staff members
• Excellent written and verbal communication skills
• Working knowledge of database (MS Access, etc.), spreadsheet (Excel) and graphical presentation (PowerPoint) programs
• Experience with electronic data collection (EDC) technology
• CCRA preferred
• Travel required up to 40%

Responsibilities Include But Are Not Limited To

1. Assisting or taking lead role in all aspects of conducting clinical studies, including: study design; protocol development and implementation; assisting sites with IRB applications; site staff training; monitoring of clinical data; adverse event monitoring and reporting; interim and final report writing.
2. Authoring clinical study protocols and supporting documents.
3. Serves as member of internal and external teams in the development of new clinical research projects or in support of ongoing projects.
4. Provide guidance to management and other staff on the direction or development of existing and/or new research projects.
5. Providing inputs to data coordinating staff into the content and design of paper and/or electronic case report forms.
6. Assuring that clinical research projects are in compliance with applicable regulations and guidelines (e.g., FDA, GHTF, ICH, GCP, HIPAA and IRB).
7. Recommending investigator criteria needed to achieve study goals, identifying appropriate investigators, and assisting Marketing department with investigator recruitment.
8. Performing appropriate statistical analyses and interpretation of clinical data for interim and final reports.
9. Assisting with the development of manuscripts, abstracts, book chapters, posters and in-house publications in cooperation with clinical investigators and/or other internal departments.
10. Staying current with orthopaedic and other relevant medical literature and assisting colleagues from other teams with literature reviews for product planning, development and marketing.
11. Developing / maintaining relationships with clinical investigators and other professionals on issues related to the Exactech Clinical Research program and the field of orthopaedics.
12. Knowing and applying the Quality System and appropriate federal and international standards.
13. Supporting other employees, team, and sales personnel as necessary.
14. Practicing Exactech Values.

Definition of Applicant for Employment at Exactech

An individual who submits his or her cover letter and resume via e-mail is considered a qualified applicant for employment if the submitted information is such that the individual is selected for an in-person interview. Exactech has the right to consider only those who apply for a position through e-mail. Once a candidate is deemed qualified, additional data will be requested regarding demographic information.

All Exactech recruiting efforts are directed toward the goal of recruiting and employing outstanding people. We strive to fill each position with the best candidate for the position whether internally or externally. All qualified applicants are considered without regard to race, color, religion, sex, age, national origin, disability, or any other protected characteristic as established by law.