Regulatory and Site Start Up Specialist

🔥 5 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟢 Junior

🚔 Compliance

👻 Ghost score 22%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Deliver timely and high-quality site activation readiness for assigned countries/sites and mitigate risks • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other applicable local bodies • Interact with Competent Authorities and Ethics Committees and handle responses • Provide regular submission updates to Start Up/Regulatory Leads and Project Managers/Project Teams • Maintain project plans, trackers, and regulatory intelligence tools • Support development of study-specific start-up plans, IMP release requirements, and essential document review criteria • Partner with site CRAs to align communication and secure site collaboration • Prepare, review, and manage essential documents for site activation and IMP release • Customize country/site-specific Patient Information Sheets and Informed Consent Forms • Coordinate document translations • Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams • Maintain site activation critical-path data, including authority and IRB/EC timelines, contracts, and budget negotiation requirements • Support study budget negotiations and investigator contract execution when required • Support feasibility site outreach when needed • Maintain knowledge of local clinical trial laws and regulations and distribute regulatory knowledge internally • Maintain audit/inspection readiness and file documents according to TMF and study-specific plans • Support Pre-Study Site Visits, process improvement initiatives, training, and mentoring • Perform other duties assigned by management

🎯 Requirements

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience • 1 year or more as a Regulatory or Site Start-Up Specialist, or comparable role, in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies • Strong communication and organizational skills • Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail • Fluency in English and, for non-English-speaking countries, the local language of the country where the position is based • Candidates must be legally authorized to work in the country of employment without employer sponsorship • Relevant regulatory and site start-up experience for the particular country preferred • Experience using milestone tracking tools/systems preferred • Ability to prioritize workload to meet deadlines preferred • Advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science preferred

🏖️ Benefits

• Regular full-time employment status • Equal opportunity employment • Reasonable accommodation during the application process