Study Startup Specialist II (18-months contract)

Psi CRO; Sydney; Hybrid; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work (2 WFH days)

Onsite parking

Learning & development

Mental wellness program

Novated leasing

Global industry exposure

Job summary

PSI CRO in Sydney, Australia, is seeking a Study Startup Specialist II for an 18-month contract to support increased project demands. You will lead startup activities, coordinate site budgets, ethics submissions and TMF maintenance, while working in a hybrid model.

The role requires at least 2 years in clinical research, a bachelor’s degree, excellent communication in English, and strong MS Office skills, with a focus on study activation timelines and regulatory documentation.

Qualifications

• At least 2 years of industry experience in clinical research as a Study Startup Specialist, or similar position with practical study startup experience in Australia.
• Bachelor’s degree or above, preferred in pharmaceutical/healthcare related majors.
• Excellent communication skills, both written and verbal.
• Full working proficiency in English.
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook).

Responsibilities

• Maintains study-specific and corporate startup tracking systems
• Facilitates site budgets and contract negotiations
• Supports site regulatory document collection
• Under supervision, may prepare initial and amendment submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable)
• Communicates with the project team and investigational sites throughout the entire duration of the study
• 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

Skills

Communication skills

English proficiency

MS Office proficiency

Education

Bachelor's degree or above in pharmaceutical/healthcare

Tools

MS Office (Word, Excel, PowerPoint, Outlook)

Job 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.

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 in Australia. You will support clinical research teams and ensure PSI projects start smoothly and on time.

We're looking for a Study Startup Specialist II to join our team on an 18-month contract to support increased project demands. This newly created role is an excellent opportunity for someone looking to gain hands‑on experience in clinical research or transition into a Study Startup position. To be considered, you must be based in Sydney and able to meet our current hybrid working arrangement.

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 and amendment submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable)
• Communicates with the project team and investigational sites throughout the entire duration of the study
• 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

• At least 2 years of industry experience in clinical research as a Study Startup Specialist, or similar position with practical study startup experience in the Australia
• Bachelor’s degree or above, preferred in pharmaceutical/healthcare related majors
• Excellent communication skills, both written and verbal
• Full working proficiency in English
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook)

Culture And Benefits

• A hybrid work arrangement with two flexible work-from-home days and three on-site days each week.
• Our office is located in Macquarie Park and we offer onsite parking for your convenience.
• Opportunities for learning and professional development.
• Access to mental wellness programs.
• Novated leasing options.
• The chance to work within a meaningful industry in a global organization setting.

How are we different?

PSI is privately owned by the very people who founded the company more than 30 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.