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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 Cheltenham 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 Cheltenham
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about introducing yourself. 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 use online platforms to refine your answers. Focus on articulating your experience in clinical site management and how it relates to the role you’re applying for.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can go a long way in leaving a positive impression. It shows your enthusiasm for the position and keeps you fresh in their minds.
We think you need these skills to ace Director, Regional Head Site Mgmt & Oversight, Europe - (Remote) in Cheltenham
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that align with the Director role. Highlight your leadership in clinical site management and any relevant achievements that showcase your ability to oversee complex trials.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to tell us why you're passionate about this role and how your background makes you the perfect fit. Don’t forget to mention your experience with CROs and site engagement!
Showcase Your Strategic Thinking: In your application, demonstrate your strategic mindset. Discuss how you've successfully navigated challenges in clinical operations and how you plan to enhance site management and oversight in our region.
Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. It’s the best way for us to receive your application and ensure it gets the attention it deserves!
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.