CRA Lead Oncology
Proclinical is advertising a vacancy for a CRA Lead, Oncology, with a leading biopharmaceutical company. The organisation specialises in various therapy areas, including oncology, neuroscience and rare disease fields, and is seeking for a driven individual to join them in a partly home-based capacity. Based in France, this is an exciting opportunity to work with an internationally renowned company and support their innovative impact in the healthcare field.
- Coordinating the clinical activities, overseeing the CRO clinical /site management activities and co-monitoring assigned clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely delivery and within budget, in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence.
- Coordinating the achievement of registrational clinical study deliverables within a matrix organisation and the support of Clinical Development Global Clinical Project Manager (GCPM), Clinical Trial Assistant (CTA), any third party staff (CROs).
- Coaching a matrix clinical team to manage the clinical study deliverables on a day to day basis.
- Ensuring efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up (DM, Reg, CMC etc) to verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation.
- Supporting and ensuring that all specific company/CRO EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardising the start of a trial.
- Supporting the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organisation and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate).
- Assisting the GCPM/ study team in the evaluation of detailed timelines and establishment of clinical studies milestones for assigned projects, ensuring that they are performed to the most rigorous standards of quality and timely delivery.
- Preparing and/or assisting in the production of all documents necessary to oversee the clinical activity implementation, monitoring and reporting in a professional, high quality and timely manner (such as monitoring oversight plan).
- Validating the final clinical study documents (such as study manual, monitoring plan) prepared by the Clinical CRO.
- Reviewing all/a sample of site visit reports as per the Oversight Monitoring Plan , ensuring timely and appropriate follow up of issues raised by monitors (Corporate & affiliates and/or CROs as appropriate).
- If applicable, providing support and guidance to Internal CRAs (Company Corporate & Affiliates with provision of some supervision in specific cases).
- Coordinating and managing the CRO relationship, assisting CRO CRAs/CTLs when and where necessary.
- Co-monitoring clinical studies according to the oversight monitoring plan, ensuring adequate contact with investigator sites, identifying and solving issues in study progress, verifying data in-house or by conducting co-monitoring visits, in collaboration with other study team members, and following up as required with CRAs/investigator.
- Participating in the ongoing clinical study data reviews in collaboration with the other study team members.
- Making appropriate and timely reporting in CTMS (Company's Clinical Trial Management Tracking System), with regular checks for quality and accuracy.
Skills and Requirements:
- CRA graduated.
- Life science or medical graduate or other relevant qualifications.
- Relevant experience of pharmaceutical drug development, monitoring and coordination of activities to set-up registrational studies.
- Experience as a Field CRA monitor at least for 3 years (CROs or Pharma Industry).
- Good Knowledge of Good Clinical Practice (GCP), ICH regulations.
- Experience in preparing clinical study documentation for study set up, maintenance and closing.
- Experience in managing and developing relationships with Contract Research Organisations (CROs).
- Languages: very good English language knowledge (oral and written).
- Strong organisational, coordinating and coaching, plus interpersonal skills.
- Excellent knowledge of Good Clinical Practices, ICH regulations and any others as appropriate.
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 Patrick Aguie at 0203 854 1077 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.