Auditor, QA Compliance Clinical Trials
il y a 3 semaines
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
As an Auditor QA Compliance, you will be responsible for meeting all internal and external audit needs, including but not limited to internal process audits and sponsor-contracted project audits in line with GCP regulations. This is an ideal role to step into for someone from with a profounda Clinical Operations background, with strong interpersonal skills and a natural flair to work in a methodical, detail-orientated and organized manner.
This position is 100% home-based and can be based in any of the countries listed on this advertisement.
What else can you expect from us?- Rewarding and meaningful work in an established, diverse, highly profitable and respected global company- Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, lunch vouchers, etc.- A genuine work life balance- Flexible work hours as per the guidelines in your country and in alignment with your teamility in working hours- A thorough onboarding with support from your personal mentor- A permanent employment contract with Fortrea- Excellent training and career development opportunities, as well as support with advancing your individual education- Strong support from your Line Manager and your team, as well as from more than 2019,000 Fortrea colleagues worldwide
Your responsibilities:
- Conduct work as identified e.g. aon the audit activity table.s per audit assignments- Support Host hosting of external audits and inspections, e.g. regulatory inspections, strategic client meetings / audits, etc.- Subsequently Ffacilitate and review audit responses.- Report on quality metrics, implement necessary corrective actions and/or process improvements via the appropriate forums (e.g. Monthly Reports, Site Quality Review, Liaison meetings).- Support the QA-to-QA relationship with our sponsors.- Deliver trainings in performance of audits.- Participate in global quality initiatives aimed at improving compliance and/or efficiency of our QA organization.- Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed.- Depending on your seniority: act as a backup for the QA Manager and provide them with monthly activity reports.
Your profile:
- Degree in a relevant field such as pharmacology, (bio-)chemistry, biology, life sciences, health management, etc.- In lieu of the above: an equivalent completed vocational training and / or equivalent professional experience in drug development, acquired either at a CRO or a pharmaceutical / biotech company- Solid experience with quality systems and standards in drug development, e.g. due to solid professional experience as a CRA / site monitor-
- Excellent interpersonal and organizational skills- Flexibility to travel internationally (primarily in EMEA) occasionally is a must- Business fluency in English (C1 and above) is a must, additional language skills are a plus
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit
REMOTE
LI-AR1
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our
Privacy Statement
.
-
Clinical Research Associate
il y a 4 semaines
Paris, France Worldwide Clinical Trials Temps plein**Requisition Number** **6980** **Employment Type***: **Regular** **Who we are** Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our...
-
Clinical Trial Pharmacist
il y a 5 jours
Paris, France Médecins sans frontières Temps pleinMédecins Sans Frontières, association médicale humanitaire internationale créée en 1971, apporte une assistance médicale aux populations dont la vie est menacée, principalement en cas de conflits armés, mais aussi d'épidémies, de pandémies, de catastrophes naturelles ou d'exclusion des soins. La section française de MSF est présente dans une...
-
Clinical Trial Manager
il y a 4 jours
Paris, France Caidya Temps plein**Job Title**:Clinical Trial Manager**Job Location**: Paris, France (Home based - any France location considered)**Job Overview**: The Clinical Trial Manager is responsible for the day-to-day leadership and management of monitoring services for clinical projects, including direct communication and interaction with investigative sites, Clinical Research...
-
Clinical Trials Assistant
il y a 4 semaines
Paris, France IQVIA Temps pleinThe IQVIA Research and Development Solutions team is focused on helping our healthcare customers to find innovative treatments solutions for patients with the common, large or rarest illnesses. Providing administrative support to the clinical teams members could make your contribution to the research. We seek dynamic and motivated people who truly want to...
-
Local Clinical Trial Assistant
il y a 6 jours
Paris, France Excelya Temps pleinCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...
-
Clinical Medical Manager
il y a 3 semaines
Paris, France Novo Nordisk AS Temps pleinAre you looking for an opportunity where you can utilize your medical knowledge to communicate scientific data and to interact with medical thought leaders? Are you passionate about the world of clinical trials? Are you highly motivated by being able to make a difference to improving patients’ lives? If so, you should continue reading and apply today! ...
-
Clinical Trial Assistant
il y a 4 semaines
Paris, France Excelya Temps pleinCréée en 2014, Excelya est une organisation de recherche sous contrat (CRO) « people centered ».Nous proposons une expérience personnelle et authentique au sein d'une jeune entreprise de santé ambitieuse en passe de devenir le leader de la recherche clinique en Europe grâce à nos 800 Excelyates. Nous nous engageons à donner à chaque Excelyate les...
-
Clinical Medical Manager
il y a 3 semaines
Paris, France Novo Nordisk Temps pleinThe position As Clinical Medical Manager, you will facilitate the execution of Global Clinical Trials related to Novo Nordisk New Therapy Areas including but not limited to Cardiometabolic and kidney disorders, Liver Disease, and Alzheimer's disease by providing medical/scientific expertise and advice based on interactions with KOLs, independent...
-
Associate Manager, Clinical Trials Regulatory Management
il y a 2 semaines
Paris, France IQVIA Temps pleinPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects. RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex Ability to administratively and technically/scientifically review core scientific...
-
Paris, France IQVIA Temps pleinPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...
-
Head of Clinical Affairs
il y a 4 semaines
Paris, France Poppins Temps pleinAbout Poppins Poppins mission is to unlock the potential of children with learning difficulties by developing medical devices for children with neurodevelopmental disorders.On a daily basis, families of children with learning difficulties (dyslexia, dyspraxia, dysphasia, ADHD, etc.) are faced with a shortage of healthcare professionals, resulting in an...
-
Clinical Research Director
il y a 6 jours
Paris, Ile-de-France Proclinical Staffing Temps pleinClinical Research Director - Paris, France - PermanentProclinical is seeking a dedicated and experienced Clinical Research Director (CRD) to manage the clinical activities of a range of products. This is a permanent position located in Paris, France.Primary Responsibilities:The ideal candidate will have a strong background in designing and monitoring...
-
Clinical Research Director
il y a 4 semaines
Paris, France Proclinical Staffing Temps pleinClinical Research Director - Paris, France - PermanentProclinical is seeking a dedicated and experienced Clinical Research Director (CRD) to manage the clinical activities of a range of products. This is a permanent position located in Paris, France.Primary Responsibilities:The ideal candidate will have a strong background in designing and monitoring...
-
Clinical Research Director
il y a 6 jours
Paris, France Proclinical Staffing Temps pleinClinical Research Director - Paris, France - PermanentProclinical is seeking a dedicated and experienced Clinical Research Director (CRD) to manage the clinical activities of a range of products. This is a permanent position located in Paris, France.Primary Responsibilities:The ideal candidate will have a strong background in designing and monitoring...
-
Clinical Scientist
il y a 4 jours
Paris, France Excelya Temps pleinCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...
-
Clinical Supply Chain Manager
il y a 3 semaines
Paris, France PSI CRO Temps pleinCompany Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 1,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...
-
Manager, Bdh Clinical Operations
il y a 4 semaines
Paris, France Biogen Temps pleinCompany Description At Biogen Digital Health (BDH), we aspire to transform Biogen and patients’ lives by making personalized & digital medicine in neuroscience a reality. Powered by data-science and digital technologies, we drive solutions to advance research, clinical care, and patient empowerment. Our team strives for real impact through excellence,...
-
Senior Clinical Research Associate
il y a 4 semaines
Paris, France AL Solutions Temps pleinJordan Griffiths has partnered with a leading CRO client who is searching for an experienced Senior CRA to join their team in France.My client is recognized for their commitment to quality and their drive for innovation in the clinical research industry. They offer a supportive and collaborative work environment where career progression is encouraged and...
-
Clinical Research Associate II
il y a 4 semaines
Paris, France Parexel Temps pleinParexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep...
-
Lead Clinical Data Manager
il y a 6 jours
Paris, France Caidya Temps plein**Job Title**: Lead Clinical Data Manager **Location**:Paris, France (Home based position - any France location considered)- Caidya is a growing, global CRO! Being a part of our team is an opportunity to change lives and contribute to the future of medicine.- Driven by a critical purpose and united values our clinical research services and knowledge sharing...
