Clinical Quality Associate

JOB SUMMARY:

This position, Clinical Quality Associate, is working towards implementing Clinical QA oversight, integrating Clinical operations into Novocures Quality system. The Clinical QA is providing GCP consultancy to stakeholders. The role of this position also includes management and performance of QA audits of clinical trials including but not limited to investigator site audits, audits of Novocure vendors, internal Operational audits in order to assure compliance with Novocure SOPs, study protocols, Good Clinical Practice guidelines, relevant regulations and EN ISO 14155 requirements. This is a remote, exemt opportunity.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Developing Risk Based audit programs, Risk Management Plans in collaboration with key stakeholders
• Assist with the development of quality assurance procedures (SOPs, WIs)
• Assist and review of Clinical Development, Clinical Operations procedures
• Develops Novocures Quality Management System - focusing on incorporating Clinical operations processes into QMS
• Stay on top of EU Clinical Trial Regulation, Medical Device Regulation, ICH GCP and guidelines from other regulatory agencies
• Deliver training to key stakeholders on current regulation, ICH GCP guidelines, ISO standards applicable to clinical investigation contribute to the review of Novocure systems and procedures as appropriate.
• Communicate/Manage quality compliance issues, CAPAs, and complaints
• Provide GCP advice and support to Clinical Development, Clinical Operations, Clinical Safety, Clinical Supply Chain
• Occasionally perform audits of clinical trials including but not limited to investigator site audits, audits of Novocure vendors, internal Operational audits in order to assure compliance with Novocure SOPs, study protocols, ICH GCP guidelines, relevant regulations and EN ISO 14155 requirements
• Participate in Inspection Readiness activities including hosting of Regulatory inspections and external audits. Support and leading audits and inspections follow-up activities
• Identify and monitor Key Performance Indicators, clinical program level trends, performs Root-cause-analysis (if necessary) and develops action plan to support process improvement
• Collaborating with clinical vendors

QUALIFICATIONS/KNOWLEDGE:

• Qualifications:

• Degree in Medicine, Technical/Scientific Studies, or equivalent
• 3 plus years of Clinical Quality Assurance experience in a Pharmaceutical, preferable in a Medical Device regulated environment; experience must involve clinicaltrial support within sponsor or CRO settings (Clinical Research Associate, Clinical Trial Managers, CRAs, CRCs or Clinical Trial Assistants) with exposure to quality.
• Proven Auditing experience
• Experience with regulatory inspections
• Knowledge of regulations for Medical Devices, especially EN ISO 14155, ICH-GCP
• Fluent English
• Able to work independently
• Willing to work in an international environment

• Knowledge:
• Excellent written and oral communications

• Analytical skills
• Consistently displays a positive, patient attitude and extends respect and courtesy toward Supervisors and peers alike.
• Leading by example and motivating others.
• Highly organized and detail-oriented.
• Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities.
• Ability to work independently with minimal supervision and as a member of a team.
• Enthusiasm, attention to detail, the ability to meet aggressive deadlines, and ability to work effectively with others in a fast paced, highly-productive environment
• Having integrity and a strong work ethic.
• Results and goals oriented.
• Willingness to travel at least 10% of time (international and domestic)

Novocure is taking a responsible approach to creating environments that allow us to strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

As part of our commitment to health and safety, COVID-19 vaccines are required for our current U.S. employees. As an Equal Opportunity Employer it is our policy to provide reasonable accommodations to any qualified individual, who, because of a medical condition, or sincerely held religious belief/practice, receives an exemption from the vaccination requirement, if such accommodation would not result in an undue hardship for the company.

For more information regarding the Novocure's COVID-19 vaccination requirement, exemptions, and verification of vaccination status please ask the Talent Acquisition Team.

ABOUT NOVOCURE:

Our vision

Patient-forward: aspiring to make a difference in cancer.

Our patient-forward mission

Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

Our patient-forward values

- innovation

- focus

- drive

- courage

- trust

- empathy

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