Clinical Operations Director

23 hours ago

Washington, United States Merit Medical Systems, Inc. Full time
Job Summary

We are seeking a highly experienced and skilled Clinical Operations Director to join our team at Merit Medical Systems, Inc. This is a key leadership role that will be responsible for the creation, implementation, and management of clinical studies of medical devices.

Key Responsibilities
  • Generate protocols and supporting study documents, including CRFs, Informed Consents, and contribute to final reports and regulatory submissions.
  • Participate in planning and communicating with Regulatory Authorities as appropriate.
  • Coordinate and oversee all activities associated with the conduct of clinical trials, including project planning, regulatory submissions, clinical quality, compliance oversight, budget management, and CRO/contractor/vendor management.
  • Manage department personnel, including interviewing, hiring, training, evaluating job performance, and disciplinary action.
  • Work with Senior management to define departmental goals and drive departmental goal achievement.
  • Provide leadership of project teams to meet key departmental milestones.
  • Oversight of identifying, qualifying, and initiating clinical sites, and ensuring quality of data collection.
  • Development of budgets for new and existing clinical studies and monitoring performance.
  • Oversight of SOP development.
  • Oversight of clinical quality department to ensure internal clinical audit schedule is developed and maintained annually.
Requirements
  • Education and/or experience equivalent to a Bachelor's degree in a biological science and twelve (12) years of clinical trial operational management experience.
  • Proven track record of increasing responsibilities and growth in a clinical affairs department.
  • Proven skills in leadership, management, and communication.
  • Self-motivated, self-directing, strong attention to detail, and excellent time management skills.
  • Strong interpersonal skills.
  • Excellent writing and oral presentation skills.
  • Strong analytical skills.
  • Excellent knowledge of GCP and ICH.
  • Demonstrated computer skills, preferably in spreadsheets, word processing, database, internet research, and other applicable software programs.
Preferred Qualifications
  • Global clinical trial experience.
  • Medical device industry experience.
  • Clinical and/or regulatory certification.
Competencies
  • Strong attention to detail.
  • Strong interpersonal skills and ability to work well with others.
  • Demonstrated organizational skills.
  • Ability to complete tasks in an accurate and timely manner, even under strict time constraints.
Physical/Environmental Demands
  • Lifting up to 50 lbs.
  • Writing.
  • Sitting.
  • Standing.
  • Bending.
  • Vision.
  • Color perception.
  • Depth perception.
  • Reading.
  • Field of vision/peripheral.

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