Clinical Research Scientist
5 mesi fa
NMS Group is the largest company in Italy, committed in innovation and research and development in oncology.
Nerviano Medical Sciences srl, representing the innovative heart of the group, is looking for a CLINICAL RESEARCH SCIENTIST Main responsibilities The Clinical Research Scientist, reporting to the Global Clinical Lead, will contribute to the development and execution of the clinical research studies in compliance with regulatory standards, company and department procedures.
He/she will be a key player in the Clinical Research Team and will work closely with the Medical Monitor, Regulatory and Clinical Operations.
Contribute to the development and execution of the clinical research studies in compliance with regulatory standards, company and department procedures.
Work closely with the research physician and other team members in the medical science group, in collaboration with other functional groups, to ensure flawless and integrated execution of study start-up activities, study oversight, and reporting of the assigned clinical studies.
Participate in and provide input to the development of the clinical strategy.
Assists in the clinical site and service vendor selection.
Contribute in the study design and the development of clinical related documents (e.g., investigator’s brochure, study protocol, informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents).
Work closely with the Medical Monitor, Regulatory and Clinical Operations to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.
Participate in investigator meetings and investigator engagement.
Perform protocol related trainings if needed.
Provide routine clinical study/project status updates; contribute to establish and maintain a strong collaborative relationship with Investigators, KOL and external project team members.
Assist in the organization of specific clinical study/project meetings(such as Advisory Board, Steering Committee, Data Safety Monitoring Board and End of Cohort Meeting), as appropriate.
Work closely with Clinical Operations to track study recruitment and implement action plans to address early sign of slow enrolment.
Work closely with the Medical Monitor and other functional groups to ensure comprehensive medical monitoring, thorough and timely responses to address site issues and eligibility questions.
Work closely with clinical research physician to anticipate and solve site issues.
To review audit findings and recommend effective corrective action plans.
Work closely with Medical Monitor and Data Management to support medical review and data query resolution.
Work with Clinical Operations to provide oversight of CRO vendors’ performance as it relates to study start-up and study conduct.
M.S, Ph.D.
Pharm.D.
or equivalent) is preferred.
A minimum of 3-5 years of working experience in a related clinical research position within the pharmaceutical industry is preferred.
Knowledge of Good Clinical Practices and regulatory requirements for the conduct of high quality oncology clinical trials is highly desirable.
Significant knowledge of cancer drug development is highly preferred.
Good oral and written communication skills in English are essential.
Successful work experience in a matrix team environment with cross functional teams is required.
Experience in clinical protocol development, medical review, oversight of study conduct, running trials, data quality and safety are strongly preferred.
Location Nerviano (Milan) and the position can be held almost completely in remote-working, with a good flexibility policy.
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