Public job listings imported for PSI CRO. These roles were added via admin CSV import or external sources.
Company Description PSI is a leading Contract Research Organization with more than 30 years of experience in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description We’re searching for a knowledgeable, team-oriented CRA II to manage the clinical aspects of full-service global projects in Japan. As a CRA II at PSI, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications.  You will build and maintain relationships with clinical sites and investigators.  You will focus on subjects’ rights, safety and well-being and quality of data compliance. You will: Conduct and report all types of onsite monitoring visits Be involved in study startup Perform CRF review, source document verification and query resolution Facilitate site budgets and contract negotiations Monitor trial progress on the country level Be responsible for site communication and management Be a point of contact for in-house support services and vendors Communicate with internal project teams regarding study progress Participate in feasibility research Support regulatory team in preparing documents for study submissions Qualifications Office is based in Japan. Tokyo or Osaka office (Hybrid)   College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience Min. 2 years of independent on-site monitoring experience in Japan Experience in all types of monitoring visits in Phase II and/or III Experience in feasibility assessment and study set-up process is preferable Experience in Multiple Sclerosis, Inflammatory Bowel Disease, Oncology, Infectious Diseases is a plus Full working proficiency in English and Japanese PC skills to be able to work with MS Word, Excel and PowerPoint Ability to plan, multitask and work in a dynamic team environment Communication, collaboration, and problem-solving skills Ability to travel up to 30% to 40% Additional Information Make the right call and take your career to a whole new level.  Join the company that focuses on its people and invests in their professional development and success.
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 3000 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 As a Senior CRA, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets. You will have the opportunity to work on clinical studies in various therapeutic areas and indications while maintaining the highest quality standards in the industry. This function operates at site and country level and can be assigned to projects as monitor or lead monitor. Join the PSI team and help drive innovation and excellence in advancing healthcare solutions. You will: Prepare, conduct and reports site selection, initiation, routine monitoring and close-out visits Perform CRF review, source document verification and query resolution Be responsible for site communication and management Act as a communication point between project teams and the site Leads project team calls on a country level Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level Participate in feasibility research Support regulatory team in preparing documents for study submissions Prepare and participate in site audits and inspections Qualifications We have an office in both Tokyo and Osaka with hybrid work arrangement.  College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience At least 3 years’ site monitoring experience at a CRA II or equivalent qualification level in Japan Experience in all types of monitoring visits in Phase II and/or III Experience in feasibility assessment and study set-up process is preferable Therapeutic area experience in Oncology /Hematology /Gastroenterology (IBD) /Infectious Diseases /Neurology/Renal is a plus Full working proficiency in Japanese and Intermediate English PC skills to be able to work with MS Word, Excel and PowerPoint Ability to plan, multitask and work in a dynamic team environment Communication, collaboration, and problem-solving skills Ability to travel up to 30% to 40%
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 3000 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 We are looking for a Director Business Development who will expand our existing client base in Japan. This role leads the sales strategy, manages the end-to-end sales process, and works closely with Operations to ensure high levels of customer satisfaction and account success. This position can be based in Tokyo or Osaka. Actively prospects and leverages potential new business opportunities within specified Customer/Accounts. Cultivates strong, long-term relationships with key decision-makers with Account and develops deep knowledge of the Customer/Account organization. Analyses potential opportunities and develops detailed business plans and sales strategies for each Customer/Account. Monitors actions and results against plans. Identifies and responds to Customer/Account needs in order to define potential PSI opportunities.  Ensures appropriate strategy/solution is proposed to Customer/Account. Works with Operations to identify sales team and prepare presentation.  Educates team participants in Customer/Account culture, operational needs/methods and sales techniques needed to close the sale. Leads the entire sales process, including identifying the appropriate team for pitch and preparing and leading the sales presentation. Coordinates with the Proposal Development Group to develop proposal and Operations to finalize strategy and pricing. Handles follow-up related to the sales and facilitates completion of contractual documents. Ensures appropriate hand-off to project team by transferring knowledge on Customer/Account needs and expectations. Shares Customer/Account strategies and sales plans with Project Directors/Managers. Coordinates with Project Managers/Directors and Operations to escalate and quickly address Customer/Account issues/concerns. Seeks input from Project Managers/Directors to proactively address Change in Scope, new opportunities or customer dissatisfaction Works with Project Manager/Director and Operations to ensure Changes in Scope (CIS’s) are appropriately negotiated with the Customer/Account. Maintains high visibility within Customer/Account organization. Monitors Customer satisfaction through regular formal and informal surveys. Coordinates with Project Managers/Directors to ensure Customer/Account needs are being met and address concerns/issues in a timely manner. Qualifications   Bachelor's degree in Health Science or equivalent professional qualifications combining education, training, and relevant experience Minimum 5-8 years of business development experience with demonstrated success in Contract Research Organizations or healt