
1001 - 5000 employees
💼 Consulting
🏥 Healthcare
📦 Logistics
Consulting • Healthcare • Logistics
Allucent is a leading partner for small and mid-sized biotech companies, offering innovative regulatory and clinical development solutions. With over 30 years of experience, Allucent specializes in therapeutic expertise, clinical pharmacology, regulatory strategy, drug safety, and the pharmacovigilance processes needed to bring new therapies to market. Their comprehensive services address challenges from early-phase drug discovery through clinical trials and post-marketing surveillance, supporting various therapeutic areas such as oncology, infectious disease, neurology, autoimmune diseases, and rare diseases. Allucent's commitment to fostering breakthrough science helps biotech companies navigate the complexities of drug development efficiently and effectively.
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1001 - 5000 employees
💼 Consulting
🏥 Healthcare
📦 Logistics
Consulting • Healthcare • Logistics
Allucent is a leading partner for small and mid-sized biotech companies, offering innovative regulatory and clinical development solutions. With over 30 years of experience, Allucent specializes in therapeutic expertise, clinical pharmacology, regulatory strategy, drug safety, and the pharmacovigilance processes needed to bring new therapies to market. Their comprehensive services address challenges from early-phase drug discovery through clinical trials and post-marketing surveillance, supporting various therapeutic areas such as oncology, infectious disease, neurology, autoimmune diseases, and rare diseases. Allucent's commitment to fostering breakthrough science helps biotech companies navigate the complexities of drug development efficiently and effectively.
• Independently ensure the integrity and quality of the medical, clinical, and safety aspects of trials conducted by Allucent • Serve as the medical monitor contact for investigators and study site teams on protocol-related and participant safety questions • Provide medical monitoring support for assigned clinical studies: respond to medical queries, assist with protocol interpretation, and review clinical data • Assist the project manager in client discussions regarding safety issues or concerns • Prepare medical monitoring plans and other relevant plans prior to study initiation • Review serious adverse events (SAEs), SUSARs, and safety reports, and analyze similar events • Assist the clinical data management team with MedDRA and WHO coding • Review clinical study documents, including protocols, informed consent forms, clinical study reports, and safety reports • Contribute to the setup and conduct of data safety monitoring boards and dose-escalation meetings • Participate in study start-up meetings, investigator meetings, and other relevant meetings, and deliver presentations as required • Provide urgent medical support on a 24/7 basis • Train project teams on the medical aspects of trials and provide therapeutic area training • Review protocol deviations • Identify study-related risks and contribute to risk management plans • Review medical deliverables, contribute to budget tracking, and attend therapeutic and drug development conferences • Maintain client relationships and participate in client assessments, visits, and proposal presentations
• Medical degree (MD) • Experience as an oncologist • At least three years of relevant professional experience with solid expertise in oncology • Good knowledge of GxP standards • In good standing with local, provincial, and national regulatory and licensing authorities, and with certification bodies • Knowledge of applicable regulatory requirements, including GDPR/HIPAA, CFR/CTR/CTD • Excellent written and verbal communication skills • Strong command of English • Ability to work in the fast-paced environment of a growing company • Strong administrative skills • Proficient in Word, Excel, and PowerPoint
• Comprehensive benefits package based on workplace location • Competitive salaries depending on location • Departmental training and education budget to support professional development • Flexible working hours (where reasonably practicable) • Remote or hybrid work options depending on location • Opportunities to move into leadership positions and access to mentoring • Participation in our buddy program, available to new hires and existing employees • Internal mobility and career advancement opportunities • Employee referral program with financial incentives • Access to online training for soft and technical skills via ADP and our internal platforms • Eligibility for our spot bonus program, which rewards exceptional project contributions • Eligibility for our loyalty rewards program, recognizing long-term service and commitment
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