SCOPE & RESPONSIBILITY:
|Lone Tree, Colorado|
Since 1996, Zynex Medical has been a leading provider of relief for patients with functional disability through the creation, distribution and marketing of the highest quality electrotherapy products available today. Zynex Medical continually strives to uphold its mission to improve the quality of life of patients suffering from debilitating pain or illness by providing the highest technology and service standards in the electrotherapy industry.
Zynex engineers, manufactures, markets and sells its own design of medical devices in three subsidiaries. Zynex Medical is a provider of electrotherapy products for home use. Zynex Monitoring Solutions develops products for cardiac monitoring for use in hospitals. Zynex NeuroDiagnostics develops devices for EMG and EEG diagnostic purposes in the neurology clinic markets.
Zynex Medical’s product line is fully developed, FDA-cleared, commercially sold, and has been developed to uphold the Company’s mission of improving the quality of life for patients suffering from impaired mobility due to stroke, spinal cord injury, or debilitating and chronic pain. Zynex Monitoring Solutions and Zynex NeuroDiagnostics are currently both in the development stages without and significant revenues.
Zynex is seeking a confident well-rounded Clinical Research Manager to focus on the day-to-day management of clinical trials and will manage the study management team, vendors, clinical monitors, and clinical trial sites. This position will also work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with regulatory guidelines, company goals, and budgets. This position is a key member of the Clinical Development team and responsible for ensuring the achievement of own or others’ project goals and objectives.
- Manage pilot trials
- Publish clinical research
- Manage and develop relationships with CRO’s
- Plan and track all clinical trial activity assigned to the department, including startup, enrollment and closeout
- Develop status reports based on department metrics and communicate to leadership
- Review proposed clinical trial budgets and protocols; assess feasibility and data requirements prior to initiation as well as on an ongoing basis
- Ensure, review and approve source documentation as required
- Build and maintain strong industry sponsor and internal team relationships to ensure effective communication
- Prepare ad hoc reports for leadership, sponsor, CROs and other individuals/groups as needed
- Receive and triage information requests; research and provide information where appropriate
- Maintain positive and cooperative relationships in day-to-day interactions and communications
- Promote effective teamwork among Clinical Trial Specialists and Data Coordinators
- Communicate and escalate unresolved issues at the appropriate time and to the appropriate level of leadership
- Participate in educational activities and programs.
- Maintain strictest confidentiality
- Ensure all staff adheres to professional standards, good clinical practice (GCP) and SOPs established for clinical research
- Knowledge: A body of information needed to perform a task; may be obtained through education, training or experience
- Knowledge of FDA guidelines and GCP
- Must be able to read, understand and comply with research protocols
- Skills: The proficiency to perform a certain task
- Strong computer skills with demonstrated ability using clinical trial databases, electronic data capture, MS Access and MS Excel
- Abilities: An underlying, enduring trait useful for performing duties
- Excellent professional writing and communication skills
- Excellent organizational and prioritizing capabilities
- Resourceful with heightened analytical abilities and problem solving skills in a fast paced environment
- Excellent interpersonal skills, detailed-oriented and meticulous