Provides leadership, direction and support for the implementation and sustainable initiatives to document clinical evidence for select BioGX products. Serves as the subject matter expert who manages clinical performance, scientific validity, and analytical performance activities for the organization. Ensures effective execution of compliance activities in accordance with international standards, regulatory requirements, customer requirements, and BioGX’s standard operating procedures herein referred to as “QMS requirements”.
The Clinical Affairs Manager will play a direct role in BioGX’s overall compliance with product registration requirements in domestic and international markets.
Essential Duties and Responsibilities:
● Directly oversees domestic & international clinical evidence activities prescribed by applicable regulatory agencies
● Provide guidance and expertise to functional areas where needed in order to continually meet evolving regulatory requirements
● Develop and maintain protocols needed to conduct scientific validations and to generate relevant clinical evidence for regulatory submissions
● Prepare written final reports containing interpretations and conclusions that are supported by results from data analysis
● Develop continuing education training materials and deliver effective training on protocols for conducting clinical studies
● Collaborate with Research & Development and Regulatory Affairs when preparing for clinical studies
● Participate in company audits and implement measurable actions necessary to achieve planned results following audits
● Adheres to good manufacturing practices and good documentation practices
● Domestic and international travel to off-site laboratories and clinical sites required
● Exercises independent judgement and decision making
● Serve as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned
● Ability to plan and manage complex and successful projects
This position does not require supervisory responsibilities at this time.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
● Bachelor’s Degree required
● Master’s Degree or PhD preferred
● Five or more years’ experience in a US FDA-regulated manufacturing environment having clinical trials expertise
● Experience working within the framework of ISO 13485 international standards, FDA 21CFR820, In-Vitro Diagnostic Directive (IVDD), In-Vitro Diagnostic Regulation (IVDR), and quality management systems
● Experience with analyzing technical data in the area of molecular diagnostics
● Excellent written and verbal communication skills
● Must have outstanding presentation and public speaking skills
● Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry
● Strong computer skills having advanced knowledge and experience with current word processing (MS Word/Good Docs), spreadsheet (MS Excel/Google Sheets), graphical, and file management software
● Proficient in typing and keyboard topology
● Extremely detail-oriented with strong planning and organizational skills
● Self driven
● Able to work without supervision
Education and Experience:
A diploma, certificate or other evidence of formal qualification, awarded on completion of an accredited university degree in law, medicine, engineering or another relevant scientific discipline. At least four years of professional experience in regulatory affairs in the area of medical devices.
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Reasoning Ability: Excellent problem solving, judgment and decision making skills are required.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while sitting or standing. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and moderate levels of noise and vibration.