Study Startup Specialist II (12-months contract) at PSI CRO

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

06 Oct, 26

Salary

0.0

Posted On

08 Jul, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Study Startup, Clinical Research, Site Budget Negotiation, Contract Negotiation, Regulatory Document Collection, Dossier Preparation, TMF Maintenance, Project Tracking, Communication Skills, MS Office

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 in Australia. You will support clinical research teams and ensure PSI projects start smoothly and on time. We’re looking for a SSU Specialist I on an 12-month contract to support our increased workload. This is a great opportunity for someone looking to gain hands-on experience in clinical research or transition into Study Startup role. Our office is based in Macquarie Park, Sydney. 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 1 year industry experience in clinical research and/or a minimum 1 year of 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) Additional Information Culture And Benefits We prioritize the well-being of our team, and as part of our commitment, we offer: 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.

Responsibilities

Lead the study activation process in Australia by managing site budgets, contract negotiations, and regulatory document collection. Maintain startup tracking systems and supervise Trial Master File maintenance to ensure projects start on time.