Senior Study Startup Associate (18-months contract)

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 3000 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.

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. 

We’re looking for a Senior Study Startup Specialist on a 18-month contract to support our increased workload. This is a great opportunity for someone looking to gain hands-on experience in clinical research. 

Office based in Macquarie Park, NSW

• Identifies and escalates operational issues to Project Management and other functions concerned.
• Leads activities in feasibility research and site identification process.
• Provides startup support for selected projects - starting from handover to Operations until all sites are activated.
• Prepares and submits the study dossiers to investigators/institutions, competent authorities, IRBs/IECs, and/or to other review bodies/research committees as required by applicable regulations.
• Participates in regional kick-off meetings/calls.
• Coordinates and supports contract negotiation process.
• Coordinates and supports preparation of IP-RED packages.
• Monitors startup key performance indicators for selected projects on country level.

• College or University degree or an equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities
• Minimum of 4 years of industry experience in clinical research as a Study Startup Specialist, or similar position with practical study startup experience in the Australia
• Excellent knowledge of FDA guidelines and ICH GCP
• Communication and interpersonal skills
• Attention to detail
• Ability to work in a team or independently

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.