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For Companies At a Glance
- Tasks: Lead clinical site operations and ensure high-quality execution of clinical programs.
- Company: Join CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Enjoy competitive benefits, including health support and a focus on well-being.
- Why this job: Make a real impact in healthcare while working with innovative therapies.
- Qualifications: 12+ years in clinical research with strong leadership and site management experience.
- Other info: Embrace a culture of inclusion and belonging while advancing your career.
The predicted salary is between 43200 - 72000 ÂŁ per year.
The Director, Regional Head Site Management & Oversight provides strategic leadership for clinical site operations, ensuring the effective conduct and supervision of site management activities and oversight for clinical programs within the assigned region. This includes alignment with our overall strategy, adherence to international regulatory standards, and delivery within agreed timelines and budget. Acting as the strategic link between therapeutic areas and investigator sites, the role ensures high-quality execution of clinical programs. The Regional Head will lead both permanent and functional service-provider site management teams while cultivating strong strategic partnerships with service providers and CROs. The Regional Head will also develop strong and lasting relationships within Medical Affairs at the regional level and with HCPs.
Main Responsibilities
- Clinical Oversight & Compliance
- Responsible for operational oversight of the site, site health and monitoring activities
- Support QA audit and inspection planning, and implementation of CAPAs as needed
- Identify and proactively mitigate site-level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs
- Study Delivery Support
- Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts
- Support sites in understanding study expectations, timelines, and required deliverables
- Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets in collaboration with CROs
- Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators/CROs
- Site Relationship & Engagement
- Build and maintain strong, trusted relationships with investigators and site staff – Face of CSL
- Serve as the sponsor primary point of contact for assigned studies
- Understand site capabilities, constraints, and strategic priorities to improve site engagement and long-term collaboration
- This role will require travel to Investigator Meetings, Investigator sites and CROs. Anticipated travel >50%
- Continuous Improvement & Site Experience
- Collect feedback from sites and advocate for process simplification and burden reduction internally
- Identify opportunities to improve study materials, and operational processes
- Represent the “voice of the site” in cross-functional discussions and initiatives
- Feasibility & Site Selection
- Provide local site intelligence to feasibility teams
- Support site development
Qualifications and Experience Requirements
- Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology
- 12 years+ relevant clinical research experience within the pharmaceutical industry.
- Experience in leading and managing a professional team with strong experience in site management, monitoring and overseeing large and/or complex global clinical trials
- A solid understanding of the drug development process, and specifically, each step within the clinical trial process
- Robust budget forecasting and management experience
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
- Proven experience in overseeing vendors and CROs
- Must have experience as a mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities
- Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges
- Must have excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report
Director, Regional Head Site Mgmt & Oversight, Europe - (Remote) in Cambridge employer: CSL Behring
Contact Detail:
CSL Behring Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, Regional Head Site Mgmt & Oversight, Europe - (Remote) in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at CSL Behring or similar companies. A friendly chat can open doors and give you insider info on the role.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s values and recent projects. Show us that you’re not just another candidate; you’re genuinely interested in how you can contribute to CSL Behring’s mission.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the role of Director, Regional Head Site Management & Oversight. Highlight your leadership skills and how you’ve successfully managed clinical trials in the past.
✨Tip Number 4
Don’t forget to follow up after interviews! A quick thank-you email can leave a lasting impression. It shows us that you’re enthusiastic about the opportunity and appreciate the time spent with you.
We think you need these skills to ace Director, Regional Head Site Mgmt & Oversight, Europe - (Remote) in Cambridge
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your relevant experience in clinical site management and oversight. We want to see how your skills align with the role, so don’t hold back on showcasing your achievements!
Showcase Your Leadership Skills: As a Director, we’re looking for someone who can lead teams effectively. Use your application to demonstrate your experience in managing teams and building strong relationships with stakeholders. Share specific examples that illustrate your leadership style.
Be Clear and Concise: Keep your application straightforward and to the point. We appreciate clarity, so avoid jargon and ensure your key points stand out. This will help us quickly understand your qualifications and fit for the role.
Apply Through Our Website: We encourage you to submit your application directly through our website. It’s the best way to ensure your application gets into the right hands and allows us to keep track of all applicants efficiently. Plus, it’s super easy!
How to prepare for a job interview at CSL Behring
✨Know Your Stuff
Make sure you have a solid understanding of the clinical trial process and the specific responsibilities of the Director, Regional Head Site Management & Oversight role. Brush up on ICH guidelines and GCP standards, as these will likely come up during your interview.
✨Showcase Your Leadership Skills
Prepare examples that highlight your experience in leading teams and managing complex clinical trials. Be ready to discuss how you've successfully navigated challenges and built strong relationships with service providers and CROs.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific site management issues or compliance challenges. Think through potential scenarios in advance and outline your approach to problem-solving and risk mitigation.
✨Demonstrate Your Passion for Patient Care
Since CSL Behring is focused on saving lives, convey your commitment to improving patient outcomes. Share any relevant experiences that showcase your dedication to enhancing the site experience and advocating for process improvements.