Start Up Associate

🔥 1 minute ago

🇪🇪 Estonia – Remote

⏱ Part Time

🟢 Junior

🟡 Mid-level

✨ Associate

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.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.

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Biomapas

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Biomapas is a comprehensive outsourcing solution provider catering to the global life science sector. The company acts as a strategic partner for biopharmaceutical and medical device companies, offering extensive clinical research services worldwide. Biomapas covers the entire product lifecycle from regulatory compliance to pharmacovigilance and medical information. The company operates across various regions including Europe, CIS, EAEU, MENA, LATAM, and the US, ensuring high-quality, efficient, and cost-effective methodologies to deliver superior service and strategic advantages. With a focus on clinical trials, pharmacovigilance, and regulatory affairs, Biomapas is equipped to navigate complex regulatory environments and manage clinical trial data effectively, contributing to clients' commercial success.

📋 Description

• Perform and manage start-up activities for assigned studies at country and site levels. • Prepare, submit, and track initial applications and amendments to Competent Authorities and Ethics Committees/IRBs and other applicable bodies. • Manage official communications with authorities and prepare RFI submission packages. • Advise study teams on local legislation and import/export requirements. • Adapt trial materials, including ICFs, labels, and patient documents, to local requirements. • Compile IP release and essential document packages for timely site activation. • Support contract negotiations with sites/institutions. • Manage translation requests and review translations of local-language trial documentation. • Update study management databases and file trial correspondence in the TMF according to SOPs and study plans. • Maintain ongoing status updates with study teams, sites, and study project management teams.

🎯 Requirements

• Bachelor’s degree in Life Sciences, Nursing, or related field. • Fluent English language. • Minimum 2-3 years of recent actual experience with Start up activities in Estonia managing submission under CTR via CTIS. • Strong knowledge in clinical research regulatory requirements at country and global levels as per GCP. • Experienced user of Microsoft Office Suite. • Attention to detail and time-management skills. • Teamwork and collaboration within study teams as well as Clients/vendors as applicable.

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