Aimee Weston的动态

Authored by Matt Gallant, senior director of business development in strategic resourcing at Advanced Clinical, and Scott Dannelley, director of quality and validation in strategic resourcing at Advanced Clinical, a new report aims to equip stakeholders with the insights needed to make informed #clinicalhiring decisions in 2025. https://lnkd.in/eVbUDXqR

Congratulations on advancing your technology for further clinical development! As you begin planning your upcoming #regulatory submission and #clinical trials, here are some functional gaps that may need to be resourced: ??Translational Science?? Translational scientists can review non-clinical literature and reports to develop clinical strategies and design protocols. ??Regulatory Affairs and Writing?? Strategic and tactical support can be used to develop your meeting request and briefing book. Non-clinical and clinical writers can help build sections of your IND submission.? ??Clinical Operations?? Clinical Operations leadership, managers, and assistants can support vendor selection and oversight. ??Biometrics ?? #Statisticians can be used to support study design, including endpoint selection, sample size considerations, and analysis methodologies. ??Data Management?? Data managers can oversee the database build and EDC operational aspects. ??Clinical/Field Monitors or Clinical Research Associates (CRAs)?? #CRAs can augment the team during the site selection and initiation processes. ? This is a small sampling of your resourcing support with BioBridges’ full-time or fractional #consultants. *** Learn more at www.biobridges.com

Navigating the staffing labyrinth in clinical operations can be as complex as the trials we oversee. ?? As we steer through the intricacies of European regulations and the diverse talent pool, I'm curious, fellow Clinical Operations Directors, how do you ensure your teams are not just staffed, but strategically composed to excel? In my journey, I've found that blending local expertise with broad-based clinical knowledge is key. ?? The right mix can propel a trial's success, especially when navigating the varied regulatory landscapes across Europe. But, how do you balance the need for specialized skills with the agility to adapt to the fast-evolving clinical trial environment? Moreover, with the rise of virtual trials and digital technologies, the competencies required in our teams are rapidly shifting. How are you upskilling your teams to stay ahead in this digital curve? ?? I'd love to hear your strategies for building resilient, future-ready teams. What's your approach to fostering a culture that not only attracts but retains top talent in this competitive landscape? #ClinicalOperations #StaffingStrategies #FutureOfClinicalTrials #HRS #Science

Working within a Clinical Trial Sites/Site Management Organization (SMO) comes with its own set of challenges. Some of the key issues include: 1. **Patient Recruitment:** Attracting and retaining the right participants for clinical trials is often an uphill battle. This can lead to delays or even failure to meet trial deadlines. 2. **Regulatory Compliance:** Keeping up with constantly evolving regulations, both local and global, can be daunting, especially when managing multiple trials. 3. **Data Management:** Collecting, analyzing, and securely storing large volumes of trial data requires robust systems and constant vigilance. 4. **Coordination with Sponsors and CROs:** Ensuring smooth communication between trial sponsors, CROs, and sites is essential but often difficult to achieve, leading to operational bottlenecks. 5. **Resource Allocation:** Managing staff and other resources effectively across multiple sites can be complex, especially in high-demand phases of trials. We tackle these issues head-on through: ? **Streamlined Recruitment Processes**: We leverage advanced patient databases and community outreach programs to identify and retain suitable trial candidates. ? **Dedicated Compliance Teams**: Our specialized team ensures that we are always up to date with regulatory requirements, minimizing trial interruptions. ? **Efficient Data Management Systems**: We invest in cutting-edge software to ensure accurate, real-time data handling across all trial sites. ? **Improved Communication Channels**: Regular meetings, updates, and a centralized platform keep all stakeholders on the same page. ? **Proactive Resource Planning**: We use forecasting tools and flexible staffing solutions to ensure each site is adequately supported at every stage of the trial. Interested in how I can support your clinical trials? Feel free to connect with us! Chintan Sheth Krish Parmar Tinku Darji SkyCraper Clinical Research Solutions Pvt Ltd Jaydev Mir #ClinicalTrials #SMO #SiteManagement #ClinicalResearch #PatientRecruitment #DataManagement #CRO #RegulatoryCompliance #Healthcare

Staffing shortages in clinical research will not be a new issue in 2025! It continues on. Possible solutions to help over come? - Integrations between systems so your teams spend less time entering data or other operational processes. - Evaluate organizational structure- is it working to garner the most efficient operations? (e.g. centralized operation vs. decentralized operation) - Clear, consistent and DOCUMENTED operational procedures! Is what you do written down? - Good reporting to glean where inefficiencies exist and identify points for improvement. - Work with your HR teams to recruit outside the box! Are you an Academic Medical Center? Use your undergraduate career center to help advertise and recruit for entry level positions. Are you a site network?? Partner with your local workforce development agency; hire a U.S. veteran! A MAJORITY of people who work in clinical research did NOT graduate thinking- this is the career path for me! We all started in different spots and wound up here! #clinicalresearch #careers #careercenters

Advarra's Site-Sponsor-CRO Collaboration Survey always provides a great insight into the challenges stakeholders are facing across the industry, and this year's edition is no different. An understanding of those challenges along with key actions to help overcome them make this a must read!

?? Finding the right people in pharma/CRO is like putting together a puzzle ?? It’s not just about matching a resume to a job description—it’s about finding the perfect fit for a team that’s tackling some of the biggest challenges in healthcare. In an industry where every role impacts the development of life-saving treatments, recruiting isn’t just filling a role; it’s building a team that can drive change. ?? What i'm always looking for? Curious minds ?? who aren’t afraid to ask “what if?” and dive into innovative approaches. Problem solvers ??? who thrive in fast-paced environments and can navigate the twists and turns of clinical trials. Collaborators ?? who know that great research happens when people with different perspectives work together. In the world of pharma and CRO, it’s about more than just skills—it’s about passion and purpose. The right people can make all the difference. ?? If you are interested in joining our mission? Check out our website for open positions! We’d love to find our next puzzle piece! https://lnkd.in/d2-9YuDJ #WeareTFS #TFSCRO #RecruitmentInPharma #LifeSciencesTalent #InnovationInHealthcare

With a projected 15.7% global clinical trial market growth by 2025, skilled talent in clinical operations is in high demand. Understanding regulatory landscapes and digital transformation is key to navigating this expansion. If you're eyeing a career move or aiming for operational excellence in trials, let's dive into strategies to lead in this thriving market. #ClinicalTrials #TalentAcquisition #OperationalExcellence

Navigating Staffing in European Clinical Operations In the ever-evolving landscape of clinical operations in Europe, staying ahead of staffing needs is pivotal. As Clinical Operations Directors, we're at the helm of ensuring our teams are robust, agile, and ready to meet the demands of innovative clinical trials. The talent pool is shifting, and with it, our strategies must adapt. How are you aligning your staffing approach to the unique challenges of the European market? From my experience, the integration of technology and the need for specialised skill sets are transforming our operations. We're not just looking for experience; we're seeking individuals who can navigate the complexities of regulatory environments across different European countries. But here's the question: How do we balance the need for seasoned professionals with the fresh perspectives of new talent? And in this competitive landscape, what are your strategies for retaining top talent within your teams? Let's discuss the future of staffing in clinical operations. What innovative approaches are you taking to build a dynamic team that can handle the intricacies of European clinical trials? #ClinicalOperations #StaffingStrategies #EuropeanMarket #Science #HRS

"99% of clinical-stage biotechs with investments in 2024 are moving away from CROs to run their trials." OK, that was bait! Let's be honest: These sensational percentages are designed to catch your attention but lack real backing. No comprehensive studies support such bold assertions. What’s actually happening? Companies are becoming more strategic with their spending. The clinical research landscape is returning to pre-COVID norms, allowing companies to be more selective in their vendor choices. CROs are adapting too, becoming more flexible and responsive to their clients' needs. This means Biotechs and Pharma companies are now more involved in their trials, sites, and overall quality management. We’re witnessing a shift from quantity to quality, which is fantastic. As a recruiter, this is where I excel: delivering QUALITY swiftly. How do I achieve this? My sole focus is networking with clinical professionals. I'm not executing trials, setting up SOPs, or selecting vendors. My job is to connect with exceptional CRAs, CTMs, PMs, and VPs of Clinical Operations, aligning my efforts with my clients' needs. In today's uncertain climate, with investments being scrutinized and upcoming elections causing uncertainty, everyone is aiming for the best quality. The market is still active, and there's demand for CROs, consultants, recruiters, and agencies. The common goal? High quality. Do you agree? What are your thoughts? #ClinicalOperationsRecruitment #Quality #CRO #Biotech