Dylan Kerns’ Post

Your time is valuable, and ALKU understands that navigating the job market in search of consultants for your next project can be time-consuming. My team is proficient in finding the top consultants for your next project based on your staffing needs. Skip the frustration of the job search, instead use the link to request support for your next Clinical or Medical Affairs project efforts: https://lnkd.in/e6tpphuv #staffing #solutions #services #clinicaltrials #clinicalresearch #medicaldevices #medicalwriting

💥 Happy Tuesday, LinkedIn! 💥 As we approach the halfway point of 2024, to say these have been the busiest 6 months of my career would be an understatement! One major industry-wide trend I've noticed over the past 6 months has been the drastic increase in demand for Clinical Operations support. If you and your team could leverage external support within any of the key areas listed below, please feel free to contact me directly at cdixon@alku.com or through DM. 🔷 Clinical Trial Management: Planning, implementing, and overseeing clinical trials to gather data on the safety and effectiveness of medical devices. 🔷 Study Protocols: Developing protocols that outline the objectives, design, methodology, and statistical considerations of clinical trials. 🔷 Site Management: Identifying and selecting clinical trial sites, monitoring site activities, and ensuring compliance with Good Clinical Practice (GCP) guidelines. 🔷 Data Management: Collecting, managing, and analyzing clinical trial data to support regulatory submissions and decision-making. 🔷 Clinical Compliance: Ensuring that clinical trials are conducted in compliance with regulatory requirements and company policies. #MedicalDevices #RegulatoryAffairs #ClinicalTrials #StaffingSolutions #Innovation #Diagnostics #Trials #NPD #Operations #Consulting #Contracting #Support #Team

Recruiting people at the right time is crucial in clinical trial teams. As the field becomes more complex with increasing regulations and data requirements, managing trials becomes tougher. Recent studies reveal a significant uptick in complexity, with eligibility criteria and endpoints soaring by 61% and 86%, respectively, from 2001 to 2020. This complexity poses recruitment challenges, with about 80% of trials facing delays or closures due to unfilled positions. Understanding the specific needs of each trial stage and recruiting accordingly is vital for improving efficiency and success rates. From data managers to grant writers, your clinical trial will comprise multiple components that require specialist clinical professionals to take action. Let’s examine the stages of trial activity, and when to recruit each team member in the article below. https://lnkd.in/dZASj4zE #clinical #clinicaltrial #clinicalresearch #clinicaloperations #clinicaljobs #clinicalrecruitment #biotechrecruitment #pharmarecruitment

🚀 The important Role of a Head of Clinical Operations   👨⚕️ RESPONSIBILITIES -      Strategic Oversight: A Head of Clinical Operations oversees the entire lifecycle of clinical trials. He/she provides operational strategy and ensures seamless coordination among various internal and external stakeholders, including investigators, service providers, sponsors, and clinical trial teams. -      Building a Competent Clinical Operations Team: A Head of Clinical Operations empowers the Clinical Operations team members, ensuring smooth planning and conduct of clinical trials. Effective communication fosters strong team relationships and keeps the team on track even under time and resource pressure. He/she provides training and development opportunities for their team members, helping them to grow and succeed in a clinical operations environment. -      Regulatory Compliance: A Head of Clinical Operations navigates the regulatory landscape and ensures adherence to Good Clinical Practice (GCP), ethical guidelines, local regulations, and SOPs. -      Communication Hub: A Head of Clinical Operations facilitates communication across teams. He/she bridges gaps, clarifies expectations, and keeps everyone informed. -      Budget Management: A Head of Clinical Operations keeps a watchful eye on clinical trial budgets and allocates resources efficiently, tracks expenses, and identifies cost-saving opportunities. -      Timeline Adherence: Meeting deadlines is critical. Heads of Clinical Operations plan timelines, monitor progress and proactively address any delays. -      Risk Management: Identifying and managing risks is part of the daily routine. A Head of Clinical Operations anticipates challenges, implements risk mitigation strategies, and keeps clinical trials on track. -      Vendor Governance: From central labs to CROs, a Head of Clinical Operations manages vendor relationships. He/she selects, negotiates, and oversees external service providers.   🎓 QUALIFICATIONS -      Regulatory Knowledge: Understanding regulatory guidelines (ICH-GCP, FDA, EMA, etc) and applying them effectively. -      Organizational Skills: Excelling at organization, prioritization, and multitasking. -      Effective Communication: Clearly communicating fosters collaboration. Heads of Clinical Operations interact with diverse stakeholders, so strong communication skills are non-negotiable. -      Problem-Solving Aptitude: Quick thinking and adaptability help navigate unexpected challenges. -      Attention to Detail: Meticulously reviewing documents and processes.   Have I missed anything? Do you see this role differently? Please COMMENT below. 📢 If you like this post, please 🤝CONNECT WITH ME via LinkedIn. Help me in increasing post reach ➡LIKE or 🌀SHARE. #ClinicalTrials #ClinicalOperations #Leadership Clinical Excellence GmbH

Are you a Medical Affairs Specialist? Interested to know the latest movement and trends within the sector? Our new Medical Affairs Industry Analytics Report is produced using independent data from our exclusive partnership with Vacancysoft, the UK's leading provider of labour market data and analytics. Take a look at the top skills in demand from employers in the Medical Affairs Industry in our latest report: https://lnkd.in/eSQ4da7S #MedicalAffairs #IndustryAnalytics

Is your team feeling stretched thin? Staffing challenges in Medical Affairs are real, but they don’t have to slow you down. From finding specialized talent to balancing workloads, we're here for you.  Read our blog to explore effective solutions that keep your Medical Affairs team performing at its best 🔗 https://lnkd.in/e6YUXsdh  #MedicalAffairs #RegulatoryAffairs #AccelerationPoint #MedicalMaterials #MedicalExcellence

Are you a Medical Affairs Specialist? Interested to know the latest movement and trends within the sector? Our new Medical Affairs Industry Analytics Report is produced using independent data from our exclusive partnership with Vacancysoft, the UK's leading provider of labour market data and analytics. Take a look at the top skills in demand from employers in the Medical Affairs Industry in our latest report: https://lnkd.in/eSQ4da7S #MedicalAffairs #IndustryAnalytics

Did you know within Medical Affairs, London saw a notable increase of 26.1% on roles last year? And did you know, Medical Advisors were one of the most common levels recruited for? For more insights and trends within #MedicalAffairs, take a look at our report!

Are you a Medical Affairs Specialist? Interested to know the latest movement and trends within the sector? Our new Medical Affairs Industry Analytics Report is produced using independent data from our exclusive partnership with Vacancysoft, the UK's leading provider of labour market data and analytics. Take a look at the top skills in demand from employers in the Medical Affairs Industry in our latest report: https://lnkd.in/eSQ4da7S #MedicalAffairs #IndustryAnalytics

Transform your approach to talent in Medical Affairs with our comprehensive course. Discover strategies that attract and retain top talent: #PeopleManagement #MedicalExcellence