Clinical Research Physician (Rif. MM) - Italy
Language: Fluent in English
Previous Experience: At least 2 year experience as Medical Monitor in
- R&D Pharma Company
- Clinical Research Organisation
- Design of the clinical development plan including all the necessary studies to adequately bring the project from first in man to marketing authorisation.
- Design of the protocols and planning of all the necessary activities to adequately carry out the Clinical Research Projects/ Clinical Trials under his/her responsibility.
- Co-ordination and supervisions of CRA, CROs, investigators and the rest of external or internal personnel in order to achieve the appropriate development of the Clinical Research Projects/Clinical Trials.
- Fulfilment of the final report of the clinical trials under his/her responsibility; adequate publication and broadcasting of the results obtained. Preparation of the clinical part of the registration dossier for a new drug or a new indication.
- Design of the protocols of the clinical trials.
- Preparation of the investigator brochure (IB) and the investigational medicinal product dossier (IMPD), in co-operation with all the departments involved, that will facilitate the suitable documentation.
- Selection of the more appropriate Investigators (and co-ordinator/s for multicentre studies) in relation with the sample size and the proposed calendar. Verification of the expertise, resources and facilities of the proposed investigators. Organisation of Advisory Board, Steering Committee, Data Safety Monitoring Board and Clinical Event Committee as appropriate.
- Clinical review (content and form) of all the documents, annexes, authorisations, etc. needed to start and correctly develop the trials, not only in their scientific aspects but also ethic, administrative and economic ones.
- Supervision of the correct design of the Case Report Forms in relation to the protocol, in collaboration with the CRA and the responsible for Biometrics.
- Supervision, planning and co-ordination of all the activities related to the starting of the study start-up (acquisition of specific material for the study, contract agreement for the external services needed, investigator-meeting organisation etc.
- Supervision of the correct development of the trials, paying special attention to the rhythm of recruitment, adopting the appropriate measures if needed.
- Supervision of the adequate monitoring of the study by the CRA or external CRO.
- Implementation and maintenance of an adequate relationship with the study investigators, participation to investigators’ meeting.
- Review of adverse events occurred during the study and report to the Drug Safety Manager and Clinical Research Director, ensuring that the procedure is done in accordance with the existing regulations and relevant SOPs.
- Review (blinded/open) of database; review of listings, medical writing for the preparation of study report
- Study results presentation/publication. Update of the IB, IMPD and other relevant document (e.g. annual safety report, IND update etc) with the study results
End of Clinical Development:
- Preparation of all documentation summarising the Clinical studies (written summary of efficacy/safety), input to the Summary of Product Characteristics
- Discussion with regulatory authorities along the approval process leading to the Marketing authorisation (worldwide).