PSI CRO logo
Study Startup Specialist I/II
full-timeTaipei City

Summary

Location

Taipei City

Type

full-time

Claim this Company

Are you the employer? Manage your company page directly.

Explore Jobs

About this role

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.

Other facts

Tech stack
Clinical Development,Study Startup,Communication Skills,Regulatory Document Collection,Budget Negotiation,Project Management,MS Office,English,Chinese

About PSI CRO

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.

PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.

PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.

PSI’s reputation is that of a 'no-nonsense'​ CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.

http://www.psi-cro.com

Team size: 1,001-5,000 employees
LinkedIn: Visit
Industry: Pharmaceutical Manufacturing

What you'll do

  • The Study Startup Specialist will lead the study activation process on a country/regional level, ensuring that clinical research projects start smoothly and on time. Responsibilities include maintaining startup tracking systems, facilitating budget negotiations, and communicating with project teams and investigational sites.

Join Clera's Talent Pool

Get matched with similar opportunities at top startups

This role is hosted on PSI CRO's careers site.
Join our talent pool first to get notified about similar roles that match your profile.

Frequently Asked Questions

What does a Study Startup Specialist I/II do at PSI CRO?

As a Study Startup Specialist I/II at PSI CRO, you will: the Study Startup Specialist will lead the study activation process on a country/regional level, ensuring that clinical research projects start smoothly and on time. Responsibilities include maintaining startup tracking systems, facilitating budget negotiations, and communicating with project teams and investigational sites..

Why join PSI CRO as a Study Startup Specialist I/II?

PSI CRO is a leading Pharmaceutical Manufacturing company.

Is the Study Startup Specialist I/II position at PSI CRO remote?

The Study Startup Specialist I/II position at PSI CRO is based in Taipei City, Taiwan. Contact the company through Clera for specific work arrangement details.

How do I apply for the Study Startup Specialist I/II position at PSI CRO?

You can apply for the Study Startup Specialist I/II position at PSI CRO directly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process. You can also learn more about PSI CRO on their website.