Manager Clinical Affairs
Department: Clinical Affairs
Employment Type: Permanent - Full Time
Location: Gainesville, FL
Reporting To: Eric Rohrs
Description
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
#J-18808-Ljbffr
