Study Startup Specialist I at PSI CRO

Taipei, , Taiwan -

Full Time

Start Date

Immediate

Expiry Date

07 Jun, 26

Salary

0.0

Posted On

09 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Study Startup, Clinical Research, Regulatory Document Collection, Contract Negotiations, Budget Facilitation, Timeline Development, Enrollment Projections, TMF Maintenance, Communication, English Proficiency, Chinese Proficiency, MS Office Suite

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 Taipei 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 Minimum of 1 years of experience in clinical development including start up process experience Bachelor’s degree or above, preferred in pharmaceutical/healthcare related majors Excellent communication skills, both written and verbal Full working proficiency in English and Chinese Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) 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. 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.

Responsibilities

The specialist will lead challenging study activation processes on a country/regional level to ensure clinical research projects start smoothly and on time. Key duties include maintaining tracking systems, facilitating site negotiations, supporting regulatory document collection, and supervising Trial Master File maintenance during startup.