Allucent

👥 11-50DatabaseCloud Data ServicesProductivity ToolsConstructionSaaSProject ManagementSoftware💼 Private Company
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Allucent is a global Clinical Research Organization focused on helping small and mid-sized biotech companies navigate drug development challenges. With over 30 years of experience across 60 countries, it offers comprehensive solutions in consulting, clinical operations, biometrics, and clinical pharmacology, emphasizing individualized partnerships and high-quality customer service.

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🔥 Sr. Proposal Manager
Posted 2 days ago

📍 United States

🧭 Full-Time

🔍 Pharmaceutical and biotechnology

  • BA/BS or equivalent in writing/journalism, business, or health-related degree, or equivalent experience.
  • 2 - 4+ years of relevant work experience.
  • Basic knowledge of GxP and applicable regulatory requirements like GDPR/HIPAA.
  • Strong communication skills and ability to translate regulations into actionable recommendations.
  • Strong analytical skills and proficiency with Word, Excel, and PowerPoint.

  • Manages overall RFI/RPI activities from initial receipt to final submission to ensure timely delivery.
  • Participates in strategy discussions to clarify scope and develop win themes.
  • Coordinates contributions of team members to create high-quality responses.
  • Formats, proofreads, and edits budgets for clarity and accuracy.
  • Supports other Business Development activities as needed.

Project ManagementCommunication SkillsAnalytical SkillsBudgetingEditing

Posted 2 days ago
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Posted 3 days ago
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🔥 Senior CRA (Australia)
Posted about 2 months ago

📍 Australia

🧭 Full-Time

🔍 Clinical research

  • At least 2 years experience in Clinical Research Operations and onsite monitoring.
  • Skills to mentor and train other CRAs in an effective manner.
  • In-depth knowledge of clinical trials and critical success elements.
  • Strong therapeutic background.
  • Proven ability to manage people and project issues.
  • Mature management skills with proactive problem identification.
  • Ability to define and meet project requirements.
  • Flexibility for improvement and creating solutions.
  • Proven organizational abilities and excellent communication skills.
  • Team player with strong customer focus.
  • Thorough knowledge of regulatory submission and reporting requirements.
  • Excellent understanding of the drug development process.

  • Governs quality standards for trial monitoring activities.
  • Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule.
  • Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
  • Tracks and supervises collection of ongoing study data for project status reporting.
  • Collects and reviews regulatory documents as required.
  • Prepares site visit reports and telephone contact reports.
  • Maintains and updates CTMS in compliance with SOPs and study-specific directives.
  • Acts as Document Owner for collected documents.
  • Aims to pro-actively prevent and mitigate issues, resolving site issues including recruitment challenges.
  • Acts as the main line of communication between the project team and the site staff.
  • Collaborates with Allucent Centralized Monitoring Team to evaluate risk-based monitoring activities.
  • Identifies potential logistical problems and supports project teams in creating solutions.
  • Ensures continuous maintenance of the Trial Master File and Investigator Site File.
  • Assists PM and CTL with generation of study specific forms and follow up.
  • Works with PM, CTL, and SSU team members to ensure authorization of documents and contracts.
  • Identifies documentation required for review by Regulatory Authorities and Ethical Committees.

LeadershipGCPCollaborationMentoringPresentation skillsDocumentationCompliance

Posted about 2 months ago
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📍 Czechia, Croatia, Poland, Latvia, Cyprus

🧭 Freelance

🔍 Biopharmaceutical

  • University degree, preferably in medicine, pharmacy, or life sciences.
  • Minimum 2 years of experience in pharmacovigilance post-marketing activities.
  • Up-to-date knowledge of global and local regulatory requirements.
  • In-depth knowledge of the pharmacovigilance legal framework in the service country.
  • Fluency in written and spoken English.
  • Must reside in the country where LCPPV provides services.

  • Acts as the primary contact for local regulatory authorities, including 24/7 availability if legally required.
  • Monitors local legislation and safety issues related to pharmacovigilance.
  • Supports audits and inspections, providing documentation and completing CAPAs as needed.
  • Involves local literature screening, safety information collection, and local submissions.
  • Responsible for local signal detection and managing risk minimization measures.
  • Reports to and communicates regularly with the EU QPPV.
  • Conducts local PV training and provides monthly activity reports on the local PV system.

Communication SkillsAnalytical SkillsCollaborationProblem SolvingAttention to detailOrganizational skillsTime ManagementWritten communicationMultitasking

Posted 2 months ago
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📍 United States

🧭 Full-Time

🔍 Biopharmaceutical

  • Graduate degree in statistics, mathematics, life science, epidemiology, or healthcare.
  • Minimum 12 years of relevant work experience and 6 years in drug development/clinical research.
  • Knowledge of GxP and relevant regulations like GDPR/HIPPA, CFR/CTR/CTD.
  • Proficient in SAS and statistical programming with strong technical and communication skills.

  • Support and provide statistical consulting services for clinical program and protocol development.
  • Contribute to clinical development strategies and address regulatory questions.
  • Prepare statistical analysis plans and review statistical documents for quality assurance.
  • Lead complex projects and manage budgets while ensuring communication with clients.

LeadershipBusiness DevelopmentSAPCommunication SkillsCollaboration

Posted 2 months ago
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