Manager Clinical Affairs

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