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- Tasks: Lead innovative processes in clinical trials and site management for impactful results.
- Company: Join CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Enjoy competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real difference in patient care through cutting-edge clinical research.
- Qualifications: 10+ years in clinical trials with strong analytical and leadership skills.
- Other info: Collaborative environment focused on innovation and continuous improvement.
The predicted salary is between 72000 - 108000 £ per year.
Primary role Summary: The PSSI Lead supports the processes associated with start-up, site monitoring, oversight and site engagement but strives to identify innovative continuous improvement opportunities with keen business analytics. They are responsible to develop and review KPIs and metrics associated with start-up, site monitoring (onsite, remote and central) and site monitoring oversight. With KPIs established, this role will need to continually monitor performance and critically assess their impact and collaborate with appropriate groups and the SMMO LT to identify trends and resolve issues and delinquencies.
The PSSI Lead monitors start-up, site monitoring and oversight processes at enterprise level using dashboards and analytics; and ensures compliance through SMMO & Partner follow-up in collaboration with Clinical Compliance. The PSSI Lead represents SMMO on SOP and process reviews, determines impact and provides recommendations or process improvement suggestions as needed.
Main Responsibilities:
- Data and Business Analysis: This role involves developing and reviewing SMMO owned operational metrics, study plan variances, and trend reports to identify issues and recommend mitigations. Developing innovative flexible and sustainable practices to drive excellence in SMMO delivery.
- Processes improvement, site quality and compliance: The PSSI Lead works closely with stakeholders proactively to ensure a consistent understanding of signals and metrics surfacing and influence the organization and CRO partners to drive process improvements and standardization.
- Serves as the initial point of contact and technical expert for questions about monitoring and oversight related processes, systems and responsibilities.
- Leads discussions with tech enablement groups both within CSL and at CRO partners to optimize AI innovations around study start-up, monitoring and monitoring oversight.
Qualifications and Experience Requirements:
- A seasoned clinical trials expert with extensive experience in global clinical trials and site management, with a strong understanding of Good Clinical Practices (GCPs) and regulatory operations.
- Minimum of 10 years experience in site monitoring or central monitoring process development.
- Strong analytical thinking and problem-solving skills are essential for interpreting complex data trends and identifying risks.
- Tech and systems savvy; experience of modelling and AI.
- Strong interpersonal skills - establishes strong relationships with customers.
- Leadership: The ability to lead discussions, build consensus, and influence cross-functional teams is important for success in this role.
- Creativity and/or ability to put innovative approaches into practice in clinical development.
- Strategic thinking and targeted problem solving skills.
- Demonstrated ability to navigate and negotiate competing priorities in a challenging environment.
- Experience in managing processes with a continuous improvement approach.
- Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions and actions.
About CSL Behring: CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
Director, Process, Standards and Signal Interpretation Lead in Maidenhead employer: CSL
Contact Detail:
CSL Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, Process, Standards and Signal Interpretation Lead in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage on platforms like LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. This will help you tailor your responses and show that you're genuinely interested in being part of their team.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. Focus on articulating your experience and how it relates to the role of PSSI Lead.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Director, Process, Standards and Signal Interpretation Lead in Maidenhead
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in clinical trials and site management. We want to see how your skills align with the PSSI Lead role, so don’t hold back on showcasing your relevant achievements!
Show Off Your Analytical Skills: Since this role involves a lot of data analysis, be sure to include examples of how you've used your analytical thinking to solve problems or improve processes in previous roles. We love seeing candidates who can turn complex data into actionable insights!
Highlight Your Leadership Experience: This position requires strong leadership skills, so share any experiences where you’ve led teams or projects. We’re looking for someone who can build consensus and influence cross-functional teams, so let us know how you’ve done that in the past.
Apply Through Our Website: We encourage you to submit your application through our website for the best chance of being noticed. It’s super easy, and it helps us keep track of all applications efficiently. Plus, we can’t wait to see what you bring to the table!
How to prepare for a job interview at CSL
✨Know Your Metrics
Make sure you’re familiar with key performance indicators (KPIs) relevant to the role. Be ready to discuss how you’ve developed or reviewed metrics in past roles, and how you’ve used them to drive improvements. This shows you understand the importance of data in decision-making.
✨Showcase Your Analytical Skills
Prepare examples that highlight your analytical thinking and problem-solving abilities. Think about times when you interpreted complex data trends or identified risks. Being able to articulate these experiences will demonstrate your fit for a role that requires strong analytical skills.
✨Emphasise Collaboration
This role involves working closely with various stakeholders, so be ready to share examples of how you’ve fostered collaboration in previous positions. Discuss how you’ve influenced teams or driven process improvements through effective communication and teamwork.
✨Be Innovative
The job calls for creativity and innovative approaches. Prepare to discuss any unique strategies or solutions you’ve implemented in clinical development. Highlighting your ability to think outside the box will set you apart as a candidate who can bring fresh ideas to the table.
