Study Startup Specialist II (~Senior level) at PSI CRO

, , Japan -

Full Time

Start Date

Immediate

Expiry Date

23 Jul, 26

Salary

0.0

Posted On

24 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical study startup, Site budget negotiation, Contract negotiation, Regulatory document collection, Submission dossiers, Trial Master File maintenance, Project management, Communication, Organizational skills, Leadership, Mentoring, Japanese language, English language

Industry

Pharmaceutical Manufacturing

Description

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 lead challenging study activation process on a country/regional level. You will support clinical research teams and ensure PSI projects start smoothly and on time. Office based in Tokyo or Osaka You will: Maintains study-specific and corporate startup tracking systems Facilitates site budgets and contract negotiations Supports site regulatory document collection Under supervision, may prepare initial submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable) Communicates with the project team and investigational sites throughout the study startup phase Develops site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones May review study specific translations Supervises Trial Master File (TMF) maintenance throughout the study startup phase Qualifications College/University degree in Life Sciences or an equivalent combination of education, training and experience 2-3 years prior clinical study and site startup experience Well-developed communication and organizational skills Ability to negotiate and build relationships at all levels Leadership, mentoring, and organizational skills Proficiency in Japanese and English language 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. PSI is an inclusive and equal opportunity employer and is committed to attracting and retaining a diverse workforce that reflects the community we serve.

Responsibilities

The Study Startup Specialist II leads the study activation process on a country or regional level, ensuring projects start smoothly and on time. Responsibilities include managing site budgets, contract negotiations, regulatory document collection, and supervising Trial Master File maintenance.