CLINICAL TRIAL MANAGER

NONSTOP PHARMA IS LOOKING FOR A CLINICAL TRIAL MANAGER FOR AN ITALIAN PHARMACEUTICAL COMPANY, MILAN 100%OFFICE BASED

THE ROLE

He/She is reponsible for the operational management of one or more pre-registration clinical studies. He/She collaborates with the Clinical Scientist, the Clinical Leader and with the Clinical R&D Manager to define and manage the assigned clinical projects.

RESPONSIBILITIES

1. Periodically updates the Clinical R&D Manager regarding his/her activities.
2. Collaborates with the Clinical Leader and the Clinical Scientist (when applicable) in defining the clinical studies strategy from the design of the study, the draft of the protocol until the finalization of the Clinical Study Report ensuring that these studies are fully aligned with the development plans of the compound, also using internal and external competences (i.e., other company departments, Clinical Research Organization).
3. Is responsible for the operational management / oversight of one or more pre-registration clinical studies and for monitoring the progress of the study.
4. Collaborates with Pharmaceutical Development in planning the quantity of drug to be used in clinical trials, contributing to the definition of the primary packaging.
5. Identifies, evaluates, and selects, in collaboration with the CL and the Clinical Scientist (when applicable), the clinical sites and third parties to be involved in clinical trials.
6. Periodically monitors the study budget and suggest changes if necessary.
7. Coordinates the drafting of contracts with any third parties involved in the assigned studies in collaboration with the CS (when applicable), and obtains final approval from the internal functions.
8. Is responsible of the relations with third parties involved in the execution of a clinical study (CRO, centralized laboratories, consultants etc.) in collaboration with the Clinical R&D Director, the Clinical Scientist (when applicable) and the Clinical Leader
9. Elaborates, reviews, updates and implements specific study documents (plans, manuals, guidelines, etc.) to support experimental sites and CRO staff
10. Guarantees that the activities carried out by CROs and third parties are consistent with the study protocol, the timing and costs defined in the contract and that these activities are in accordance with the applicable legislation and operating procedures and quality standards
11. Promotes corrective and preventive actions in case of major deviations from the approved protocol, ICH- GCPs, guidelines, local regulations and SOP in collaboration with the Clinical Scientist (when applicable).
12. Checks the consistency and completeness of the documents that are part of the TMF, at the end of the study collects all the sections, including those archived at CRO, and transfers the TMF to the GCP archive

Collaborates with the Clinical R&D Safety Manager / Clinical R&D Physician in the aspects related to the safety profile of the investigational drug under study and in drafting relevant documents, in collaboration with the Research and Development Director and the Clinical Scientist (when applicable)

REQUIREMENTS

• Degree in scientific disciplines of the biomedical area
• Good knowledge of English both spoken and written (at least B2 level).
• Use of IT tools (PC, E-mail, Office Package, Internet)

If this role sounds like something you would be interested in, please send your CV to my email address F.Raucci@nonstopconsulting.com or via Linkedin.

If this role is not quite right for you but you would like to have a conversation about other roles, do not hesitate to connect with me.