Main tasks and responsibilities (in cooperation with the Head of Quality Management):

• Maintain GCP/ICH and ISO 9001 compliant systems and processes which control the quality of work and clinical trials conducted 
• Write and/or review clinical SOPs and support continuous process improvements
• Manage training of staff on company procedures, GCP regulations, and documentation systems
• Manage induction training for new employees and for scientific consultants
• Qualify critical vendors
• Perform documentation control in the TMF and quality reviews of clinical trial essential documents and associated documentation (including Protocols, Investigator’s Brochure, CRFs, etc.) as appropriate
• Perform routine internal System and TMF audits and checks throughout the lifecycle of a trial/program to ensure compliance with internal procedures, as well as regulatory guidelines
• Report significant clinical quality deficiencies and/or risks to upper management and actively participate in solving the issues
• Perform clinical site GCP auditing activities to ensure that studies are conducted in accordance with protocols, GCP and other applicable regulation
• Participate in Sponsor Audit and Competent Authorities Inspections

Minimum requirements:

• Scientific Degree (ideally Master/ PhD in Biology, Biotechnology, Life Sciences, etc.)
• At least 3 years of experience in Clinical Quality maintenance and oversight 
• A high level of English language, both written and spoken
• Excellent interpersonal skills, ability to work in teams, flexibility in changing tasks and priorities and motivation for new challenges
• Preferred: qualified Auditor according to Italian Decree on CRO Minimum Requirements (15.11.2011)

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Job overview

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.

Key responsibilities

• 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

Qualifications

• 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

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