Do you need assistance to make the most of your research project’s clinical development plan?
Our team of experts is available to help you.
Via Cesare Battisti, 1
20122 Milan (MI)
Join the PRINEOS team!
We are a collaborative and close-knit group of Life Sciences experts who share the goal of innovating clinical and healthcare research projects.
We believe in and value our people, allowing each one to express their skills and opinions to contribute to an efficient execution of the projects we work on, aware of the added value each individual resource can provide. By combining competencies, we improve the quality of work.
PRINEOS offers an international, dynamic and stimulating work environment, with numerous opportunities for development and professional growth based on relationships of trust as well as an open, honest, respectful and proactive communication.
We seek and value talented people who share our values and contribute to the growth of PRINEOS.
You can apply for our open positions or fill in the form for a spontaneous application: we might be interested in having you in our team!
PRINEOS is looking for a Medical Advisor with sound experience in clinical research and in planning, supervision, and implementation of scientific activities. The Medical Advisor will directly report to the Chief Medical Officer and supporting the Medical Manager will be the clinical reference person for Clients in the therapeutic areas of interest.
- Advisory Board and Steering Committees planning and management
- Clinical trial documentation preparation (concept sheet, study protocol, synopsis, informed consent etc)
- Clinical Study Report preparation in cooperation with biostatisticians
- Support the Client in the Investigator Brochure revision and update
- Ensure timely delivery of high-quality results
- Plan, organize and prioritize workload for assigned projects and tasks
- Medical/scientific degree (e.g. medicine, biology, pharmacy, biotechnology)
- At least 2 years of experience in either a biotech, CRO or pharma company
- Medical-scientific knowledge of the main therapeutic areas on which PRINEOS is focused (such as Pulmonology, Gynecology, CNS, Onco-hematology, Ophthalmology)
- Knowledge the regulatory documentation in clinical trials (synopsis; protocol; clinical study report; etc.), with preferable previous experience as a medical writer
- Knowledge of procedures, policies, and regulations in clinical research and pharmacovigilance
- Previous experience in managing activities of clinical evidence communication
- Ability to transfer contents/knowledge (training)
- Team working
- Ability to work independently and efficiently under tight deadlines
- Strong organizational and time management skills
- Excellent verbal and written communication skills
- Proficient written and spoken English
The Clinical Project Manager is in charge of planning and overseeing all the aspects of a delegated study/project. He/she contributes in the timelines definition and operates to meet project's goals on time and within budget. He/she establishes strategies to achieve the study commitments acting as the point of contact for the client and for the study team. He/she plans, executes, maintains oversights and reports on clinical trials, from planning, vendor selection and site feasibility, through study close out. He/she leads and provides direction to the Study Team to ensure all trial outputs.
Tasks and responsibilities:
- Define and drive study timelines and milestones
- Define the needs for External Service Providers (ESPs), identify and select ESPs, including negotiation of scope of work and budget and ensure that related contracts comply with internal procederes and GCP requirements
- Oversee study approval processes
- Oversee forecasting of IMP and study supplies
- Review and approve feasibilities
- Perform ongoing ESP management, performance management and issue resolution
- Work within the clinical trial core team alongside study and program leads
- Provide study specific direction to study team members and ensure that they are regularly updated on the study progress, challenges and risks through-out the duration of the study
- Provide regular study status updates including critical issues
- Track and manage assigned budgets in line with study plans
- Act as a contact for clinical trial sites
- Support the management and implementation of new clinical systems as needed
- Follow GCP and ensure compliance with local and company regulations
- Address enrolment and retention issues, identify and implement actions to keep study on track
- Ensure proper study documentation is maintained and archived
- Resolve issues in a proactive and timely fashion and escalate unresolved issues and identified risks
- Create, manage and ensure tracking of study budget including revisions
- Master degree or equivalent university education/degree in life science or healthcare
- Minimum of 10 years relevant experience in clinical development and clinical trial management (field monitoring experience is preferred)
- Experience in executing a wide range of clinical trial activities (from initiation to clinical study report)
- Experience selecting and managing external service providers
- Very good understanding of clinical trial budget
- Thorough understanding of the drug development process
- Advanced knowledge of ICH-GCP and other relevant clinical trial regulations
- Fluency in English, both written and oral (additional languages would be a plus)
- Communication and interpersonal skills
- Ability to negotiate and resolve conflicts