Study Start-up Submissions Expert

3 hours ago


Melbourne, Victoria, Australia beBeeAnalytical Full time $100,000 - $115,000
Regulatory Submissions Specialist

We are seeking a Study Start-up Submissions Specialist to join our Clinical Operations team in Melbourne, Australia.

  • Efficiently manage and successfully execute all aspects of global start-up;
  • Perform quality checks on submission documents and site essential documents;
  • Prepare and approve informed consent forms;
  • Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
  • Present during bid defenses, general capabilities meetings, and audits.
Key Responsibilities

The ideal candidate will have:

  • More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
  • Regional experience will be highly advantageous;
  • Strong oral and written communication skills.
Requirements

To succeed in this role, the candidate will need:

  • Experience managing and executing global start-up processes;
  • Strong analytical and problem-solving skills;
  • Ability to work effectively in a team environment;
  • Excellent communication and interpersonal skills.


  • Melbourne, Victoria, Australia Emeritus Research Full time $90,000 - $120,000 per year

    Emeritus Research is leading the way in clinical trials, known for our innovation, energy, and commitment to excellence. We're currently seeking a passionate and experienced Study Start-Up Specialist to become a key member of our dedicated Trial Advancement Team.If you're ready to make a meaningful impact in a fast-paced, high-performing environment—apply...


  • Melbourne, Victoria, Australia Tfs Healthscience Full time

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.**Join Our Team as an Associate Director, Study Start Up** -...


  • Melbourne, Victoria, 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,...

  • Start Up Specialist

    5 days ago


    Melbourne, Victoria, Australia Labcorp Full time

    Develop awareness of regulatory legislation, guidance and practice in the assigned countries with the support from senior staff? Assist senior staff to compile, prepare, submit and obtain approval of the submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements? Liaise with internal and external vendors in the...


  • Melbourne, Victoria, Australia beBeeClinicalResearch Full time $90,000 - $135,000

    We are seeking a talented professional to join our Study Start Up Team.The successful candidate will play an integral role in ensuring that physicians at research sites are prepared to start clinical trials of new pharmaceutical and biological products.The Role:- Review and negotiate clinical site investigator contracts and budgets.- Stay connected with...


  • Melbourne, Victoria, Australia beBeeregulatory Full time $100,000 - $115,000

    Regulatory Submissions SpecialistWe are currently seeking a Regulatory Submissions Specialist to join our Clinical Operations team in Melbourne, Australia.About the RoleThis is an exciting opportunity for a highly skilled and motivated individual to manage and execute all aspects of global start-up. The successful candidate will perform quality checks on...


  • Melbourne, Victoria, Australia Medpace Full time

    Regulatory Submissions (Study Start-up) ManagerJoin to apply for the Regulatory Submissions (Study Start-up) Manager role at MedpaceRegulatory Submissions (Study Start-up) ManagerJoin to apply for the Regulatory Submissions (Study Start-up) Manager role at MedpaceWe are currently seeking a full-time, office-based* Study Start Up Submissions Manager to join...


  • Melbourne, Victoria, Australia Medpace Full time

    Regulatory Submissions (Study Start-up) ManagerJoin to apply for the Regulatory Submissions (Study Start-up) Manager role at MedpaceRegulatory Submissions (Study Start-up) ManagerJoin to apply for the Regulatory Submissions (Study Start-up) Manager role at MedpaceWe are currently seeking a full-time, office-based* Study Start Up Submissions Manager to join...


  • Melbourne, Victoria, Australia Icon 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,...

  • Global Start-Up Lead

    2 weeks ago


    Melbourne, Victoria, Australia beBeeManager Full time $100,000 - $115,000

    Regulatory Submissions Manager RoleWe are seeking an experienced Regulatory Submissions Manager to manage and execute all aspects of global start-up, perform quality checks on submission documents, prepare and approve informed consent forms, review pertinent regulations, and present during bid defenses and audits.Key Responsibilities:Efficiently manage and...