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Cosa significa lavorare
in Menarini

COSA SIGNIFICA LAVORARE IN MENARINI

Chi lavora in Menarini fa la differenza, ogni giorno.

Per realizzare la nostra mission  siamo sempre alla ricerca dei talenti migliori, di persone determinate, capaci di lavorare in team e che possiedano spirito d’iniziativa, flessibilità ed entusiasmo, ma siano anche pragmatiche e capaci di lavorare per obiettivi, portando valore aggiunto alla posizione che ricopriranno.

 

Clinical Research Physician (Rif. MM)

Area: Clinical Research Line: R&D Clinical Research Department: Job Centre: Menarini Ricerche - Firenze

PROFILE

Education: Degree in Medicine; post-graduate diploma in one out of the most relevant therapeutic area of our R&D, namely Oncology, Pain & Inflammation, Gastro-Enterology. Language: Fluent in English Previous Experience: At least 2 year experience as Medical Monitor in

 

  • R&D Pharma Company

  • Clinical Research Organisation

 

GENERAL DUTIES & RESPONSABILITIES

It is the general responsibility of the Medical Monitor to design, organise and co-ordinate all the activities related with Clinical Research Projects (mainly Clinical Trials), from the beginning to the end in order to obtain data foreseen in the relevant protocols and/or clinical development plans in the established timeframes and according to the guidelines internationally accepted on good clinical practice, the internal company SOPs and regulations in force.

Specific responsibilities of the Medical Monitor are:

 

  • 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.

 

Deep knowledge of the therapeutical areas related to the Clinical Research Projects or Clinical Trials under his/her responsibility and close surveillance of the application of company SOPs, as well as regulations in force and internationally accepted guidelines regarding clinical research.

MAIN ACTIVITIES AND TASKS

Definition of the optimal clinical development plan and clinical trials need to be completed in order to achieve the marketing authorisation of new drug/additional indication, together with the design of each individual Clinical trial constitute the major bulk of work to be done by medical monitors in the general frame of activities of the clinical research department. In this context there are three main stages of activity:

Preparation of the Clinical Development plan:

Number of studies per each development phase, their sequence, total number of patients exposed in light of the regulatory wordwide requirements need to be addressed in the clinical development plan, indicating bottleneck, go/no decision steps, timelines and costs of clinical development.

Preparation or Pre-study activities:

 

  • 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.

 

Development. Activities during study conduction:

 

  • 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.

 

End of study. Activities after end of clinical phase

 

  • 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).

 

We especially appreciate receiving résumés from the disability protected class, as defined by Law 68/99, which meet the requisites illustrated above.

To send your résumé, click on the link my résumé and select "RIF. MM - Clinical Research Physician" reference from the drop-down menu "preferred position" 

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