Study Start Up Specialist

1 week ago

Sydney, New South Wales, Australia Novo Nordisk Full time

About the department
Novo Nordisk is a global healthcare company with nearly 100 years of innovation and supervision in diabetes care.

The Novo Nordisk Oceania affiliate is a high performing and growing organisation operating within a dynamic healthcare environment across Australia and New Zealand.

Our primary therapy areas are diabetes and obesity, and we offer a broad range of medicines within the areas of haemophilia, growth disorders and women's health.


The position
The Senior SSU CRA is involved from site selection to site activation.

You will take the leadership in formulating the optimised submission strategies with the aim of reducing the number of required submissions and approval timeframes.

Reporting to the Operational Excellence & Quality Manager in Clinical Development Centre (CDC) Oceania, you will lead in managing and executing the SSU activities in the allocated clinical trials in compliance with local regulations, ICH-GCP (Good Clinical Practice), Novo Nordisk procedures and protocol requirements for studies placed in Australia and New Zealand.


This position requires:

  • Mapping of SSU strategy for each site, assigning lead sites as applicable and planning approval timelines in consultation with Trial Managers (TMs). Also, involved in the preparation of study budgets in consultation with TMs and negotiates with trial sites including finalisation of Clinical Trial Research Agreements and Indemnities
  • Build and maintain close relations and collaborations with all Novo Nordisk CDC staff within Oceania to ensure optimal trial delivery, specifically working towards key startup KPI of 80% site activated at country First Patient First Visit (FPFV) for trials in the CDC and adjacent
  • Proactively identifies any risks in SSU and site activation plans to relevant stakeholders, develops and implements mitigation strategies as required.
  • Prepares relevant handover documentation to allow TMs and CRAs to effectively manage ongoing and amendment submissions post site activation. Also, need to adapt to the changes to the approval process and incorporate into Novo Nordisk processes
  • Ensure Site Initiation Visits are ready to be scheduled and site activation documentation is on track as per agreed timelines with the TM and in collaboration with the assigned CRA

Qualifications

  • Degree or equivalent in life science, medical or pharmacy is essential
  • Solid knowledge of clinical trials ethics and regulatory approval process in Australia and New Zealand, confirmed as a minimum of 2 years working in clinical research in any applicable function
  • Good knowledge of clinical trial methodology along with uptodate knowledge of the clinical trials environment
  • ICH GCP, regulatory issues, Standard Operating Procedures (SOP's)
  • Good presentation skills with negotiation and basic legal experience (desirable)
  • Computer literacy and IT skills including Microsoft Office, Word, Excel & PowerPoint. Also, usage of a variety of internal and external IT systems e.g., Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), ERM, HREA, Coupa, novoTime

Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities, and difficulties.

For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work.

Ultimately, life is why we're all here - to ensure that people can live a life free of chronic disease.


Contact

Deadline
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.


At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world.

We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures.

We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in.

Together, we're life changing.

LI-AMS1

  • Study Start-up Lead

    1 week ago

    Sydney, New South Wales, Australia ICON plc Full time

    Clinical Trial - Study Start-Up LeadLocation: Sydney, Australia (hybrid)As a Study Start-Up Lead, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.You will be working alongside a world-leading pharmaceutical company. This 19- year partnership is focused on leveraging cutting-edge...

  • Study Start

    1 week ago

    Sydney, New South Wales, Australia NES FIRCROFT Full time

    BHPosted: 10/05/2023 Competitive remuneration Australia New South Wales Sydney Permanent Life SciencesStudy Startup Specialist- Full-time, permanent position:- Remote / office based / hybrid working opportunities: A company that highly values teamwork, camaraderie and enthusiasmA truly exciting opportunity to join a growing Australian study start-up team...

  • Study Start Up Associate Ii

    1 week ago

    Sydney, New South Wales, Australia ICON plc Full time

    At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...

  • Study Start Up Associate II

    4 weeks ago

    Sydney, New South Wales, Australia ICON Clinical Research Full time

    Opening: Study Start Up (ANZ IOD) Country: Australia or New Zealand Working schedule: Permanent headcount, office based (Australia), remote based (New Zealand) *please note: > title level and remuneration will be adjusted based on interview assessment and internal equity review ICON plc is a world-leading healthcare intelligence and clinical research...

  • Study Start Up Associate II

    1 month ago

    Sydney, New South Wales, Australia ICON Clinical Research Full time

    Opening: Study Start Up (ANZ IOD) Country: Australia or New Zealand Working schedule: Permanent headcount, office based (Australia), remote based (New Zealand) *please note: > title level and remuneration will be adjusted based on interview assessment and internal equity review ICON plc is a world-leading healthcare intelligence and clinical research...

  • Sales Specialist

    1 week ago

    Sydney, New South Wales, Australia Australia Study Full time

    Sydney-based student agency (Townhall), international team, flexible working hoursYour job: Promoting our services Recruiting international students Counseling on most relevant study pathways Preparing enrollmentsYour profile: English: Intermediate French: Native Bubbly and outgoing personality WHV and Student visa welcomeRemuneration package: Fixed salary +...

  • Study Start Up Cra

    1 week ago

    Sydney, New South Wales, Australia Novartis Full time

    XCommitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._Minimum requirementsXDivisionGlobal Drug DevelopmentBusiness UnitGCO GDDCountryAustraliaWork LocationSydneyCompany/Legal EntityAU Pharma Pty LtdFunctional AreaResearch &...

  • Study Site Specialist

    1 week ago

    Sydney, New South Wales, Australia SYD Fortrea Australia Pty Ltd Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Marketing Specialist

    1 week ago

    Sydney, New South Wales, Australia Seven Migration Pty Ltd on behalf of Trip Study Pty Ltd Full time

    OverviewTrip Study is a dedicated Educational Agency with a primary focus on connecting Brazilian students with reputable Australian Institutes.We are looking for a Marketing Specialist to join our team. In this pivotal role, you will be instrumental in crafting and implementing effective marketing strategies to elevate the visibility and reputation of Trip...

  • Regional Clinical Study Manager

    1 week ago

    Sydney, New South Wales, Australia BeiGene Full time

    EmployeeFull timeAbout the Company:BeiGene, Ltd (NASDAQ:BGNE;HKEX:06160;SHA:is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 9,500 employees across the United States, China, Europe and Asia Pacific region, BeiGene is advancing a pipeline consisting...

  • Regional Clinical Study Manager

    1 week ago

    Sydney, New South Wales, Australia BeiGene Full time

    Job Description: Job Description About the Company:BeiGene, Ltd (NASDAQ:BGNE;HKEX:06160;SHA:is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 9,500 employees across the United States, China, Europe and Asia Pacific region, BeiGene is advancing a...

  • Global Clinical Study Manager

    1 week ago

    Sydney, New South Wales, Australia BeiGene Full time

    EmployeeFull timeAbout the Company:BeiGene, Ltd (NASDAQ:BGNE;HKEX:06160;SHA:is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 9,500 employees across the United States, China, Europe and Asia Pacific region, BeiGene is advancing a pipeline consisting...

  • Study Support Assistant

    1 week ago

    Sydney, New South Wales, Australia ICON Full time

    Clinical Trial Study Support AssistantLocation: Research Clinic in Sydney (Australia)As Study Site Support Specialist, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence in a part-time FTE), permanent employment.You will be supporting a long-term partnership with one of the most...

  • Insights Specialist: Join a Tech Start-up Firm That

    1 week ago

    Sydney, New South Wales, Australia Flow Recruitment Australia Full time

    PublishedJune 27, 2023LocationSydney, AustraliaCategoryQuantitative researchJob TypeFull-timeDESCRIPTIONTo AUD$100,000 p/a plus shares & other amazing employee benefits.Flow is excited to be working with a tech start-up firm that is revolutionizing brand health tracking. Clients are snapping at the heels of this intuitive and smart product adding it to their...

  • Site Activation Specialist

    1 week ago

    Sydney, New South Wales, Australia IQVIA Full time

    We are currently looking for a Site Activation Specialist on a 6 month fixed term contract. Immediate StartIn this role, you will serve as the Single Point of Contact (SPOC) in assigned studies, acting as the main liaison between investigative sites, Site Activation Manager (SAM), Project Management team, managing and executing start up and site activation...

  • Site Activation Specialist

    1 week ago

    Sydney, New South Wales, Australia IQVIA Full time

    We are currently looking for a Site Activation Specialist on a full time 12 month fixed term Paternity Leave contract. In this role, you will serve as the Single Point of Contact (SPOC) in assigned studies, acting as the main liaison between investigative sites, Site Activation Manager (SAM), Project Management team, managing and executing start up and site...

  • Sales Specialist

    1 week ago

    Sydney, New South Wales, Australia Axsys Full time

    We're MYOB Hi And thanks for stopping by MYOB is the #originalstartup. Our roots are in finance and accounting software, but today we're so much more We're building a business management platform to help more businesses in Australia & New Zealand Start, Survive & Succeed. Our team is continually transforming, inventing and disrupting conventions. We don't...

  • Aipc - Student Support Officer

    1 week ago

    Sydney, New South Wales, Australia UP Education Full time

    Are you someone who possesses exemplary interpersonal and organizational skills, with a keen interest in providing outstanding support to students? Are you looking to be the first point of contact with potential new students, help encourage them to enrol into our program, and then nurture them along their journey?About the role:We have an exceptional...

  • Cu Up Close

    1 week ago

    Sydney, New South Wales, Australia Clayton Utz Full time

    At Clayton Utz, we're dedicated to making a positive impact on our industry and community. We aim to create a professional and supportive environment where our people can thrive and grow.The CU Up Close Program is an opportunity for law students in their pre-penultimate year of study to get an exclusive look into life at Clayton Utz, one of Australia's...

  • Soe - Partnerships Manager

    1 week ago

    Sydney, New South Wales, Australia UP Education Full time

    UP Education's purpose is to provide an exceptional learning experience for students that meets the skill needs of a changing work environment. We imagine what is possible if we think boldly and design study to be fully flexible within a digital world. Our educators use bespoke digital learning solutions tailored to each individual student to meet their...