As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
At PRA, borders do not create boundaries. PRA's success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages - yet operate in unison as one worldwide PRA community.
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We are looking for a Trial Manager 100% sponsor dedicated and based in Milan. This manager will coordinate local and mainly non- interventional studies in Italy although other countries may be assigned.
Working outsourced and fully dedicated to one of our global pharmaceutical clients, the Trial Manager is responsible for the successful management and execution of study activities at a country level. The Trial Manager is accountable for leading with success the execution of local company data generation activities in one or more countries for project(s) assigned.
This includes all project activities starting from Request for Services and high level budget estimate through protocol development to delivery of final Clinical Study report (CSR) or other deliverable(s), according to planned milestones, within budget, and with high quality standards per company procedures and regulatory requirements.
The TM serves as the single point of end-to-end accountability for assigned project(s); leading the Study Management Team (SMT) for local studies, interfacing with the Clinical Teams, stakeholders from local Medical Affairs or other internal trial sponsors, external service providers.
The TM acts as the single point of accountability for end-to-end project management including high level budget estimate, protocol development, trial set-up, execution, close-out, analysis and reporting.
Bachelor's degree or equivalent required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
Minimum of 5 years of clinical trial management experience in the pharmaceutical industry or CRO.
Clinical operations knowledge, project management and proficient communication skills are required. Computer literacy is also required.
Excellent decision-making and strong financial management skills are essential for this position.
Effective study team leadership skills and proven ability to foster team productivity and cohesiveness.
Experience in managing all study types (interventional, non-interventional, registries) is preferred.
Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.
If you have any questions please email or call our recruitment department at (0) .
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.