The Clinical Quality Manager (CQM) will be responsible for prospective and proactive quality control and oversight of the quality activities related to clinical trials sponsored by the customer and its associated vendors of clinical trials. The primary responsibilities will be to ensure that clinical processes are conducted in accordance with the customer Quality Management System and Plan and applicable GCP requirements.
The Clinical Quality Manager will report to Head of Quality Management and will support global clinical studies for all product candidates, with one or more indications, from early clinical development to regulatory approval (Phase 1-3) and beyond.
Main activities are:
Establish and maintain strong relationships with internal and external stakeholders to ensure that quality standards are proactively adhered to and collaborate with global GCP QA (Quality Assurance) members to ensure compliance according to the established quality system.
Serve as the GCP subject matter expert on various clinical development projects by providing high standard of quality guidance, advice, and support on GCP matters.
Identify potential system gaps within clinical trial conduct and coordinates with the appropriate stakeholders to ensure timely remediation.
Escalate issues of critical non-compliance and/or lack of urgency in remediation to quality assurance and clinical development management.
Attend cross-functional team meetings as needed and provides guidance to clinical operations staff to ensure best practices that include the customer oversight and control of clinical trial conduct and risk-based management.
Establish mechanisms for the department to design, measure, assess, and improve the quality of the clinical trials deliverables.
Work effectively with clinical staff and external partners to investigate deviations reported from clinical studies and/or investigational sites and works with teams to ensure trend and impact analysis are performed.
Support GCP QA and/or clinical development in the development and implementation of quality improvement programs.
Conduct ongoing reviews of clinical trial documentation proactively ensuring quality, accuracy, and completeness.
Contribute to the customer SOP (Standard Operating Procedures) development and review process.
All other responsibilities as assigned.
Qualifications
BS degree required, MS or advance degree a plus - preferably in a scientific area.
Minimum of at least 5-8 years of clinical operations and quality assurance experience and a minimum of 3 years clinical trial oversight experience including working with third party partners or an equivalent combination of education and experience.
Excellent communication and negotiation skills.
Maintain high ethical standards and enjoy working with people and information, making decisions, problem solving, making a difference and working in a leadership role.
Must be a self-starter and used to working independently, however collaborating and ability to influence peers is key.
Adhere to ethical and good clinical practices and the ability to work as part of a team. As well as work independently in a remote workforce environment.
Excellent organizational skills and ability to work on multiple projects with competitive timelines is required.
Strong attention to detail and respect for the need of accuracy of information.
Exceptional verbal, written, and interpersonal communication and presentation skills.
Must have a thorough understanding of applicable US (United States) and international GCP regulations/guidelines to facilitate the interpretation and impact of findings of internal and external audits.
Intermediate to advanced software skills desired (e.g., Microsoft Excel, PowerPoint, Microsoft Project).
Demonstrate ability to work effectively in cross functional team environment.
What we offer:
We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers , eco vouchers, mobile phone (data included)
We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, ...)
Side activities will be organised regularly, to achieve a close collaboration within our team
We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
We contribute to a number of charities & support the research and / or the patients in our industry.