Clinical Research Regulatory Coordinator
il y a 6 jours
Our Pfizer Clinical Research Unit (PCRU) in Brussels is a state-of-the-art research facility with sixty inpatient beds dedicated to early clinical trials (Phase 1 & 2a studies). Pfizer disposes of only two CRUs worldwide, one in New Haven (USA) and one in Brussels (Belgium). Clinical trials are executed in these facilities with the help of healthy participants essentially and sometimes patients, and these early phase studies are key in the development of new medicines which will at term help patients worldwide. The studies run in the PCRU are set up in collaboration with US and UK Study Teams, based on the most accurate protocols.
Clinical Research Regulatory Coordinator
creating, initiating, coordinating, monitoring and maintaining clinical study site documentation.
This is what you can look forward to:
Preparation and Online submission of Clinical Trial Applications in CTIS
- Responsible for communication with the NCP, for preparing the required Part I and Part II files, and completing CTA submissions in the CTIS platform.
- Responsible within the Regulatory Team to ensure that studies are conducted scientifically and ethically and in compliance with EMA/FDA/ICH/GCP/Belgian/GDPR guidances and regulations/laws.
- Lead the administrative work related to the lifecycle of trials (CSR, ASR, SUSAR, AE, etc.), and ensure proper documentation and communications to relevant stakeholders;
Part I: CTA Quality and Scientific Information
- Coordinates with PCRU PIs and Pharmacists, RegCMC and Dev Ops colleagues to ensure timely availability and accuracy of all the required (IMP-related) documents.
- Coordinate and ensure the translations and redaction of relevant submission files for assigned protocols.
Part II: Member State specific Information
- Solicit input from local clinical teams on assigned synopses, protocols and Informed Consent Documents (ICDs) where appropriate;
- Ensure the accuracy of managed ICDs and their translations, as well as related regulatory documents for assigned protocols (recruitment strategy, all other participant-facing documents,...)
Other
- Responsible for study-specific tasks such as site registration in CTMS/Oracle Siebel and Shared Investigator Platform (SIP), QC and filling of study documents in PTMF as well as maintenance and archiving of study files (ISF)
- Act as an SME for SOP updates and review within the functional line
- Responsible for providing oversight on specialized regulatory related PCRU projects
- Liaison to the project teams for studies scheduled in the PCRU to provide inputs on regulatory aspects (EU CTR, Belgian law,);
- Responsible for the implementation of new processes and work to proactively resolve issues where appropriate;
- Develop knowledge of the GDPR and optimize its implementation at the PCRU.
- Lead PCRU teams in accomplishing business needs and resolving issues;
- Develop and maintain relationships with schools and universities for training site registration
- Give input in PCRU documentation to facilitate positive attitude and trust of participants toward clinical research.
Training
- Participate in training courses as appropriate, and train Regulatory team members with less experience and expertise;
- Assist in the training of PCRU staff and contractors with less experience and expertise
- Responsible for complying with Pfizer Standards, ethical standards, ICH, regulatory and applicable legal requirements.
What you offer:
Qualifications / Skills
Minimum level of education:
- Bachelor’s degree in Management, Life Sciences or equivalent, with relevant experience in Regulatory Affairs.
- A Master in the above-mentioned domains is preferred.
Functional / Professional Competencies Specific to the job:
- Autonomous but with a strong team spirit
- Accountable, with very keen sense of initiative and leadership skills
- Strong organizational skills, multiple projects flexibility and very good resistance to stress or a high workload, with focus on the agreed timelines.
- Detail oriented, precise in oral and written communication
- Strong IT skills: advanced use of MS365 tools such as Outlook, Word, Excel, PowerPoint, Teams, OneNote.
Experience:
- Min. 5 years of experience in pharma, of which at least some years in a regulatory environment
Languages : Fluent in French, Dutch and English
Technical requirements
- Scientific / Medical Knowledge
- Demonstrated understanding of the complexities and recent developments in exploratory research.
- Participates to the successful study conduct of PCRU studies in accordance with ethical, legal, and moral standards, Good Clinical
Practices, Good Laboratory Practices,
Organizational Relationships
- Reports to Clinical Operations Director
- Pfizer discovers, develops, manufactures and distributes medicines and vaccines. Pfizer wants to contribute to better health and wellness for everyone, at every stage of life. Pfizer works with the government and other health partners to provide quality and accessible he
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