Precision For Medicine
Precision For Medicine
Precision For Medicine este o organizație de servicii din domeniul sănătății și științelor vieții, care ajută companiile farmaceutice și de biotehnologie să dezvolte și să comercializeze terapii, având expertiză în oncologie, boli rare și afecțiuni autoimune. Activitatea sa combină gestionarea studiilor clinice, serviciile de laborator, colectarea de probe biologice, capacitățile de analiză a biomarkerilor și sprijinul pentru producție, pentru coordonarea unor programe complexe de dezvoltare. Prin conectarea acestor servicii de-a lungul procesului de cercetare clinică, Precision For Medicine ajută echipele să abordeze provocările operaționale și să ducă potențialele tratamente mai aproape de pacienți.

Regulatory and Site Start-Up Specialist - Australia Remote

Support clinical trial submissions and site activation for Precision For Medicine, a life sciences CRO. Manage essential documents, ethics approvals, contracts, and country-specific regulatory compliance.

Descriere

  • Coordinate timely, high-quality site activation readiness across assigned countries and sites while identifying and mitigating risks.
  • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other relevant local bodies.
  • Communicate with Competent Authorities and Ethics Committees and manage their responses.
  • Provide recurring submission updates to Start-Up or Regulatory Leads and Project Managers or Project Teams.
  • Maintain project plans, tracking tools, and regulatory intelligence systems.
  • Help develop study-specific start-up plans, IMP release requirements, and essential document review criteria.
  • Work with assigned site CRAs to coordinate communication and build site collaboration.
  • Prepare, review, and manage essential documents for site activation and IMP release.
  • Adapt country- and site-specific Patient Information Sheets and Informed Consent Forms.
  • Coordinate document translation requirements and related activities.
  • Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams.
  • Serve as the subject matter expert for site-level critical-path and site-activation data.
  • Assist with study budget negotiations and investigator contract execution when needed.
  • Support feasibility outreach to potential sites as required.
  • Keep current with local clinical trial laws and regulations and share relevant knowledge internally.
  • Maintain audit and inspection readiness and file documents in line with TMF and study-specific plans.
  • Assist with Pre-Study Site Visits when required.
  • Contribute to process improvements, training, and mentoring.
  • Complete additional duties assigned by management.

Cerințe

  • Bachelor’s degree in life sciences or a related discipline, Registered Nurse (RN) qualification, or an equivalent combination of education, training, and experience.
  • At least one year of experience as a Regulatory or Site Start-Up Specialist, or in a comparable CRO, pharmaceutical, or biotech role, with equivalent relevant experience or demonstrated competencies also considered.
  • Strong communication and organizational abilities.
  • Experience with computerized information systems, electronic spreadsheets, word processing software, and email.
  • Fluency in English and, when applicable, the local language of the country where the role is based.
  • Legal authorization to work in the employment country without employer sponsorship.
  • Preferred: regulatory and site start-up experience relevant to the specific country.
  • Preferred: experience with milestone tracking tools or systems.
  • Preferred: ability to prioritize work and meet deadlines.
  • Preferred: advanced medical or life sciences degree, RAC certification, or a Master’s in Regulatory Science.

Beneficii

  • Regular full-time employment.
  • Equal Opportunity Employer.
  • Reasonable accommodations are available for applicants with disabilities.

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