Responsible for leading the clinical affairs team to conduct effective clinical research and provide publication and presentation support for the company. This position will take a lead role in creating the clinical research support structure for: protocol development, identification of clinical sites, clinical research agreement negotiation, site initiation and oversight of interim monitoring, periodic reporting of study results, and other related activities.
Key Responsibilities
Help establish the strategic vision for the clinical affairs department in coordination with the Business Unit leadership team.
Define ways to leverage clinical research information to drive market share.
Manage Exactech team personnel and clinical research contractors in support of Exactech's clinical research needs.
Lead and support the clinical research committee.
Support clinical research related regulatory and compliance activities.
Lead the clinical research team, including daily operations, resource management, budgeting, and workload prioritization.
Provide knowledge and strategic planning support to the company's business units, sales and marketing, engineering and regulatory departments related to clinical research.
Oversee the planning, execution, and management of all clinical research studies and activities including but not limited to:
Study design development and clinical protocols implementation
Study-site assistance with IRB process and documentation preparation
Investigator requirements, recruitment and contracts
Study-site budgetary needs
Compliance with applicable FDA, ISO, ICH/GCP and HIPAA requirements
Study monitoring
Data collection, processing and archiving/maintenance
Statistical analysis and interpretation of clinical data
Final reports
Support the identification, selection, and continuing management of external clinical support organizations (e.g. CROs, biostatistics support, etc).
Oversee the development of manuscripts, abstracts, book chapters, posters and in-house publications in cooperation with clinical investigators. Maintain a repository for these materials.
Oversee the development of annual regulatory and compliance reporting.
Stay current with orthopaedic and other relevant medical literature.
Develop / maintain relationships with surgeons and other professionals on issues related to Exactech's research program and the field of orthopaedics.
Participate with other teams on product planning, design, development and marketing projects.
Know and apply Exactech's Quality Management System and appropriate federal and international standards.
Support other employees, teams, and sales personnel as necessary.
Skills Knowledge And Expertise
Education:
Bachelor's Degree from an accredited institution required; Master's Degree preferred
Experience can offset education
Experience:
Minimum 8 years clinical research experience required
Minimum 2 years supervisory or management experience required
2 years experience in IDE/ Post market approval regulated studies required
Knowledge of applicable federal and international regulations and guidelines (FDA, ISO, ICH/GCP, HIPAA) required
Orthopaedic background required. Experience with total joint replacement studies and biologics material studies preferred
Functional/Technical Knowledge, Skills and Abilities Required:
Well developed verbal and written communication skills
Detail-oriented with strong organizational skills
Creative problem-solving and critical thinking skills
Flexibility and willingness to work with a variety of people
Strong technical writing skills
Familiarity with data acquisition platforms (EDC) and firm understanding of bio-statistical concepts (ability to use SPSS or equivalent statistical programs)
Working knowledge of MS Office database platforms, spreadsheets and graphical presentation programs
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Medical Equipment Manufacturing
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