Study Startup Specialist I

1 week ago

Taipei, Taiwan PSI CRO Full time $60,000 - $80,000 per year
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.

  • Study Startup Specialist I/II

    1 week ago

    Taipei, Taiwan PSI CRO Full time $80,000 - $120,000 per year

    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...

  • Site Readiness and Reg Specialist I

    7 days ago

    Taipei, Taipei City, Taiwan Fortrea Full time $70,000 - $120,000 per year

    Job OverviewPrimary contact with investigative sites during study maintenance and -when assigned-, site startup activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and Site...

  • T&I Manager

    1 week ago

    Taipei, Taipei City, Taiwan Synera Renewable Energy Full time $90,000 - $120,000 per year

    Synera Renewable Energy (SRE) is seeking a Subsea Cables Transport & Installation (T&I) Lead to join our team in Taipei, Taiwan. The successful candidate will oversee the development and execution of the Subsea Cables T&I scope, managing both technical and commercial aspects to ensure successful project delivery. This role requires close collaboration with...

  • CTO and/or Technical Co-Founder

    7 days ago

    Taipei City, Taipei City, Taiwan Art Of Next Full time $70,000 - $120,000 per year

    Looking for a CTO and/or Technical Co-Founder for a New AI StartupI have an idea and plan, but failed to use outsourced developers to build an MVP for me. For this reason, I would love to meet someone who will join me in a technical role and work together. I am excellent at growth, business development, sales, and marketing, and can understand technical...

  • Change Control Specialist

    6 days ago

    Taipei, Taipei City, Taiwan Inspiren Full time $70,000 - $120,000 per year

    About the companyInspiren offers the most complete and connected ecosystem in senior living. Founded by Michael Wang, a former Green Beret turned cardiothoracic nurse, Inspiren proves that compassionate care and technology can coexist - bringing peace of mind to residents, families, and staff.Our integrated solutions seamlessly fit into existing workflows,...

  • Clinical Application Specialist

    1 week ago

    Taipei, Taipei City, Taiwan W. L. Gore & Associates Full time $90,000 - $120,000 per year

    About The RoleWe are looking for a Clinical Application Specialist to join our team. In this role, you will work closely with regional and global stakeholders by developing and leveraging deep clinical knowledge to support development, engineering to provide product training and technical support for commercially available products as well as support...

  • HRM Specialist

    1 week ago

    Taipei, Taiwan Coupang Full time $40,000 - $80,000 per year

    Coupang is reimagining the shopping experience with the goal of wowing each customer from the instant they open the Coupang app to the moment an order is delivered to their door. Our services in Taiwan include "Rocket Delivery" which offers next-day delivery for a wide selection of items at affordable prices, "Rocket Oversea" which offers free international...

  • Start-up Specialist

    3 days ago

    Taipei, Taipei City, Taiwan Fortrea Full time $104,000 - $130,878 per year

    This role is for upcoming future opportunities that may arise at Fortrea.Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your...

  • Workflow Automation Specialist

    2 days ago

    Taipei, Taiwan PicCollage Full time $70,000 - $120,000 per year

    About Us: We are a profitable and growing company, originating in Silicon Valley and now headquartered in Taiwan. We combine intuitive design with Creative AI tech to create inspiring products for millions of people worldwide.We offer a fun, creative, and international workplace with competitive compensation, stock options, flexible hybrid work, free...

  • Workflow Automation Specialist

    24 hours ago

    Taipei, Taipei City, Taiwan PicCollage Full time $70,000 - $120,000 per year

    About Us:We are a profitable and growing company, originating in Silicon Valley and now headquartered in Taiwan. We combine intuitive design withCreative AItech to createinspiring productsfor millions of people worldwide.We offer a fun, creative, and international workplace with competitive compensation, stock options, flexible hybrid work, free lunch, and...