Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Take your career to the next level and manage clinical study startup activities in Japan. You will share your expert knowledge, develop clinical project startup strategies, provide operational support and ensure that PSI projects start smoothly and on time. 

Office based in Shanghai

You will: 

Develop startup strategies and oversee startup activities in the regionLead and manage all clinical study startup activities/processes with local project teamsMonitor and evaluate operational resources involved in startup activitiesManage and train startup team membersProvide study startup updates to Project Managers and Country HeadsFacilitate cooperation between cross-functional teams regarding startup activitiesSupport operational teams in feasibility research, site identification and selectionOversee study submissions to competent authorities, ethics committees, and other review bodiesOversee preparation of documents for drug release to clinical sites and entire site activation processOversee site contracting activitiesDevelop and update manuals, local instructions, and user guides relevant to Study Startup activities within the assigned country and provides local expertise and best practices to other PSI functions and clients.

QualificationsCollege/University degree in Life Sciences or an equivalent combination of education, training and experienceMinimum of 7 years prior clinical study and site startup experienceWell-developed communication and organizational skillsExperience in leadership managing peopleAbility to negotiate and build relationships at all levelsLeadership, mentoring, and organizational skillsExperience as a Senior CRA, Clinical Trial Lead or Project Manager is a plusProficiency in Chinese and English languages, both written and verbalDemonstrated ability to manage multiple projects simultaneously and meet tight deadlinesStrong problem-solving skills and ability to work independently in a fast-paced environment