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Clinical Development Specialist

2 weeks ago

Melbourne, Victoria, Australia beBeeOperations Full time $100,000 - $140,000
Job Description:

We are seeking a proactive and adaptable Clinical Operations Associate to provide critical support across clinical study operations. This role offers the opportunity to gain broad exposure to early-phase clinical development, with involvement in study start-up, vendor management, regulatory documentation, and study tracking.

  • Support sponsor responsibilities for regulatory submissions and maintain relevant documentation
  • Coordinate with site staff for ethics submission timelines and other investigator-led materials
  • Track CRO-led project activities and deliverables, escalating delays or risks to the sponsor study team
  • Review meeting agendas, minutes, and action logs prepared by the CRO and ensure timely follow-up
  • Maintain study trackers and dashboards, including timelines, milestone status, and site readiness indicators
  • Support TMF/eTMF oversight through spot checks, QC of essential documents, and reconciliation activities
  • Liaise with vendors to support alignment and communication
  • Assist with safety documentation review workflows in collaboration with CRO/pharmacovigilance provider
  • Support reconciliation of data across key systems under direction of the sponsor or CRO
  • Track vendor invoices and assist with budget tracking and reconciliation
  • Contribute to the development and maintenance of sponsor-controlled documents, logs, trackers, and QMS documentation
  • Assist with vendor identification and RFI coordination for future studies
  • Support country feasibility assessments and site identification activities
  • Contribute to clinical operations input on protocol drafts, informed consent forms, and study plans
  • Assist with budget model development and forecasting for future Phase 2 studies
  • Help prepare cross-functional operational plans, including timelines, risk logs, and resource needs
Key Responsibilities:

The Clinical Operations Associate will be responsible for providing support to the study team and ensuring the smooth execution of clinical trials.

Requirements:
  • Bachelor's degree in life sciences, pharmacy, public health, or a related discipline
  • Understanding of ICH GCP principles and Australia's clinical trial landscape
  • ICH GCP certification (current or to be obtained before study start)
  • Strong written and verbal communication skills
  • High attention to detail and strong organisational skills
  • Ability to work independently and take initiative in a dynamic, fast-paced setting
  • Previous experience in a clinical trial coordinator, CRA, or clinical project support role
  • Experience working with CROs and vendors
  • Familiarity with TMF systems and clinical trial project management tools
What We Offer:
  • Opportunity to contribute to a FIH clinical study in a growing Australian biotech
  • Exposure to end-to-end clinical development activities
  • Hybrid working model with flexible hours
  • Supportive and collaborative team culture
  • Potential for role evolution as the program advances
Company Culture:

We have a supportive and collaborative team culture that values employee growth and development.

About Us:

We are a growing Australian biotech company advancing a novel inhaled antisense oligonucleotide therapeutic for the treatment of chronic respiratory disease.