A leading biopharmaceutical company, which develops and commercialises medicines in Oncological, Neuroscience, and Rare Disease fields, is currently recruiting for a Clinical Trial Coordinator (CTA). Based in the company's Paris office, this role is an exciting opportunity to bring experience and dedication to this internationally successful company.
Job Responsibilities:
- Setting up and administrating the company's eTMF or set up the paper TMF files
- Maintaining and completing the paper and electronic TMF for company documents and appropriate filing of documents.
- Identifying, requesting and ensuring delivery of outstanding and outdated documents.
- Identifying and preparing documents for country requirements in the framework of regulatory submissions as needed.
- Periodically during study course and at the end of the study, review overall study TMF (whatever format or location e.g. CRO e-TMF/e-TMF or paper TMF) for organization, quality, and for completeness as per ICH GCP requirements.
- Reviewing and QC checking of the TMF to ensure their quality and completeness in view of audit or / and inspection or archiving.
Archiving:
- Following up and review of financial documents, in collaboration with Global Clinical Research Manager (Company's or partner GCRM).
- Creating and updating financial information within SAP (Internal Order, Purchase order, goods receipt & invoices).
- Creating Commitment Requests within the K2 tool.
- Creating and update financial trackers.
- Following up of invoices and delay in payments.
- Helping to prepare forecast and assist at quarterly review meetings of study budget with CRM and local finance controlling department.
- Completing files for Transparency Office requirements (France, EFPIA, US) or receive and check against study activities in collaboration with the CRM, and forward files from Service providers and final uploading into company's Transparency Tool (Collect).
Coordinate and conduct in-house and external clinical operations activities:
- Following up on execution/signature of Clinical contracts and populate iCap with finalised contracts.
- Clinical supplies coordination (K2 dispatch order) when there is no IVRS.
- Internal Meeting preparation and co-ordination.
- Tracking of company's Oversight of a study (e.g. CRO monitoring visit reports).
- Insurance requests and renewals.
- Legal administrative documents obtention and follow up (POA, LOA, CDA's, Kbis).
- Updating of shared study electronic site (SharePoint or other tool) - Mailing of study documents by express courier, as requested.
- Organising appropriate logistics for any Sponsor meetings (invitation/room booking/lunch order).
- Assisting as appropriate in the project management and monitoring of clinical studies, including liaison with, monitors, CROs, drug vendors, central laboratories and other vendors for study related tasks.
Clinical Trial Management System Data Entry:
- Responsible for data entry and status updates within the CTMS (Hermes) using a Clinical Manager technical role for the assigned studies, with support of CRM if needed.
- Performing any other activity as may reasonably be required from time to time to ensure the accurate, quality and timely execution of clinical studies.
- Completing all of the above activities within the framework and in compliance with R&D SOPs and other documentation in force within the company's Group.
Conduct activities in accordance with rules and values:
- In his domain of activity, to respect the regulation, to apply the company's good practices and standards, and the EHS procedures set up on the site.
- Participate at the EHS training, proposed in the framework of the training at post of work.
- Contribute to reduce the environmental impact of the activities on the site.
- Inform his superiors of any changes affecting the post of work, so that the single document evaluation of occupational risks can be updated, as well as any useful information to better take into account the EHS on site.
Skills and Requirements:
- 3-year degree (BAC+3)
- 2-year degree (BAC+2) or 3-years (BAC+3) of related work experience and training or equivalent combination.
- Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader
- Basic Financial Knowledge
- Knowledge of Pharmaceutical Industry R&D
- Good knowledge of the Good Clinical Practices (GCP).
- Experience (or knowledge) of regulatory documents or medical
- Travel Requirements: 2 times a year in Europe and possible in rest of the world.
- Experience in Clinical Operations area related work is preferred. Scientific background preferred.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Valaince Penteng at 0203 846 0643 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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