Biomapas
Biotechnology • Pharmaceuticals • Healthcare Insurance
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.
201 - 500 employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Project Manager
Job not on LinkedIn
October 29
Biomapas
Biotechnology • Pharmaceuticals • Healthcare Insurance
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.
201 - 500 employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
📋 Description
• Projects SUPM oversight: manage oversight of start-up activities (starting from feasibility completed till sites’ activation) within assigned projects. • CA and EC submissions management: oversee the preparation and submissions of clinical trial applications under EU CTR and other applicable country level regulatory requirements. • Site start-up management: supervise sites documents collection for CA and EC submissions and for IP release /essential documents packages. • Client management: acting as the primary point of contact to the Clients during start-up trials phase, developing trials SSU timelines and submission strategy in collaboration with the clinical Pm and the Client. • Cross-functional leadership: coordinate trial start-up activities in close cooperation with Clinical Operations, Regulatory Affairs, Contracts & Budgets, Vendor Management departments. • Risk & Time management: develop and maintain SSU strategy and timelines as per committed to Clients’ deliverables. Timely identify potential bottlenecks or study start up processes, suggest and implement mitigations strategies.
🎯 Requirements
• Strong understanding oof EU CTR and CTIS submission process, proven experience of submissions done via CTIS (Part I and Part II). • Proven experience being a Start-up PM, Start-up lead within CRO, managing multicounty studies. • Strong knowledge of ICH-GCP, local regulatory frameworks, and clinical trial lifecycle • Exceptional organizational, time-management and communication skills. • Managing start-up activities in multicounty or global trials is a major plus. • Ability to work both independently and as a key trial team member. • Experience managing start-up activities in Ukraine, Georgia, Kazakhstan Armenia, or similar emerging clinical research regions is a plus. • English fluent, local languages proficiency is an advantage.
🏖️ Benefits
• International team and environment • Performance based annual bonus • Remote Work, Workation & Flexibility • Health & Wellbeing – wellness initiatives • Professional growth and development in the Life science industry • Team Culture – Team buildings, global meetings, and B Active events. • Comprehensive Insurance - Personal accident, business trip coverage, and additional health insurance.
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