A well-known international pharmaceutical company with sites around the globe is looking to hire a Clinical Scientist to be based in Milan on a permanent basis. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology.
The Clinical Scientist is responsible for bringing together clinical, scientific and technical disciplines to ensure high quality protocol development, study execution and data interpretation.
They will be responsible for clinical sciences deliverables on one or more interventional clinical trials, with the opportunity to work across multiple Therapeutic Areas within Global Product Development (GPD).
The Clinical Scientist is a key member of the study team and partners closely with the Therapeutic Area clinician and clinical operations team members, applying technical and scientific excellence to support the development and execution of clinical trials to meet the needs of internal and external customers.
Specific Clinical Scientist responsibilities impact key elements of the study lifecycle including protocol and Informed Consent Document (ICD)development, safety and quality data review, patient narratives and Clinical Study Report (CSR) development.
Job Responsibilities:
- Provides scientific expertise to produce clinical study protocol
- Ensures appropriate Case Report Form design, creates ICDs, and is responsible for the election and implementation of Patient Reported Outcomes
- Partners with data management to develop data review plan for review of data.
- Responsible for establishing and management of Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes
- Reviews patient level and cumulative data per the data review plan across a study and coordinates with TA Clinician for study level review.
- Reviews protocol deviations.
- Reviews safety data, Serious Adverse Event (SAE) reports, Targeted Medical Events, Designated Medical Events, and ensures clinical documents (eg. ICDs) are updated as required.
- Tracks and reconciles SAEs across a study and reports SAEs during Safety Review Team meetings.
- Collaborates with TA Clinician to provide medical/scientific guidance during the execution of the study.
- Ensures Trial Master File compliance for clinical sciences study level documents.
- Answers specific site protocol questions as needed.
- Develops specific medical/protocol training for Site Initiation Visits and Investigator Meetings, for the company site facing roles and vendor / CRO staff.
- Identifies scientific quality issues to discuss with clinicians and operations study team members so that corrective actions may be instituted.
- Provides scientific input to and review of CSRs including writing of narratives.
- At the asset level, assists the Global Clinical Lead and TA Clinician in the preparations of the clinical content of regulatory submissions/documents (e.g. (supplementary) New Drug Application, Marketing Authorisation Application, Investigational New Drug, Investigators Brochure (IB), Annual Report, medical narratives).
- May support and contribute to various sections of regulatory documents (Pediatric Investigational Plan, IB, IND/NDA Annual Reports, Periodic Safety Update Reports, and Regulatory authority responses).
Skills and Requirements:
- Required: BA/BS or equivalent qualification.
- Ph.D., Veterinary Medical Doctor, M.S., and/or PharmD. or equivalent qualifications. Postgraduate training/certification/ fellowship in a clinical / scientific discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.)
- Knowledge and experience in Good Clinical Practices
- Experience in execution of clinical trials, including data review and investigative site relations
- Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval)
- Practical experience in clinical trial strategies, methods and processes
- Track record of design, oversight and interpretation of clinical studies
- Proven scientific writing skills, with strong inter-personal, written/verbal communication skills, including ability to evaluate, interpret and present complex data
To Apply:
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 call Maria Salvador on +44 203 8037 872 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.
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