This is an entry level position r esponsible for maintaining and overseeing the compliance program across all departments at OmniComm Systems Inc.
Professional, adaptability, possess strong teamwork building capabilities; excellent time management skills; strong communication skills to articulate complex issues; self-starter with ability to work within a large team environment. E xcellent presentation, training and interpersonal skills are required.
Coordinate and/or oversee SOPs, including Master SOP List maintenance and tracking, training, version control, and biennial revision schedule. Participate in Compliance Committee activities as a committee member; coordinate meetings, prepare agendas, minutes and action items. Help coordinate and perform internal audits against SOPs, regulations, and internal processes. Coordinate audit activities and scheduling with external auditors. Track and collect audit responses as well as corrective actions. Prepare external audit response follow-up supporting documentation and pro-active corrective action status reports to clients. Compile company compliance status reports for review by Sr. Management. Work with training department to ensure timely training and associated documentation including new hire orientation. Work with Global VP QA and department heads to ensure compliance adherence across the organization. Learn GCP, FDA regulations, quality assurance concepts, SOPs, and auditing techniques. Review Training files against training matrix requirements.
Must have highly developed interpersonal skills with the ability to successfully collaborate with peers, subordinates and cross-functional teams in order to achieve defined goals. Excellent presentation skills and understanding of appropriate communication methods within all organization levels. Must have good written and verbal communication skills, with the ability to clearly present to both technical and non-technical audiences. Ability to understand and interpret industry regulations, quality concepts and guidelines.
Prior experience with software development a plus. Excellent verbal and written communication skills. Excellent presentation skills in small and large group situations. Strong ability to establish direction and to motivate, and inspire team members. Willingness to learn GCPs, FDA regulations, quality assurance concepts, SOPs, and auditing techniques. T wo years direct experience in related fields in the medical industry a plus. Office Staff level position responsible for the coordination and completion of compliance documents for all business units in OmniComm as directed by the Global VP QA. Advanced degree or 2 years working in the clinical trial industry using EDC software or other regulated industry a plus. Previous training experience a plus.
Monster - 2 years ago
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OmniComm Systems, Inc. provides Web-based Electronic Data Capture (EDC) software and services that streamline the clinical research process....