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.

PSI’s business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies.  We help our clients to generate data about safety and efficacy of medications and bring the best ones to market.  By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life.  Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients.

We offer an inspiring story of the company that has grown organically from a handful of countries to global presence.  PSI is a mature company with standards and practices, but we do not stand still.  Every day, there is a figurative Everest to climb, and you will not get bored here.

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. 

This position can be located in Tokyo or Osaka. 

(Hybrid work)

You will: 

Lead and manage all clinical study startup activities/processes with local project teamsDevelop startup strategies and oversee startup activities in JapanParticipate in development and update of project/country startup and site activation timelines. Ensures that startup deliverables in assigned country are met.Lead and facilitate activities on negotiation of site agreement and/or budget to ensure alignment to the site activation planSupervise preparation and/or submission of the study dossiers to sites, to the competent authorities, IRBs/IECs, etc.Communicates with the project team and investigational sites throughout the study startup phaseMay review study specific translationsMonitor and evaluate operational resources involved in startup activitiesManage and train startup team membersDevelop 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 experience in JapanWell-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 Japanese and English languages, both written and verbalIn-depth knowledge of ICH-GCP guidelines and Japanese regulatory requirementsDemonstrated ability to manage multiple projects simultaneously and meet tight deadlinesStrong problem-solving skills and ability to work independently in a fast-paced environment

Additional Information

How are we different?

PSI is privately owned by the very people who founded the company more than 25 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms.  

Being a Part of the Team

As a part of the PSI team, you will have a fair degree of ownership and autonomy to make nuanced country-and department-specific adjustments while nurturing the global PSI culture that unites us across six continents.

You will receive continuous support from your global peers and join a fast-paced, innovative, and results-oriented working environment with lean communication lines. We pride ourselves on being approachable, receptive to new ideas, and open to feedback.

Growth Opportunities

PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.

PSI is an inclusive and equal opportunity employer and is committed to attracting and retaining a diverse workforce that reflects the community we serve.