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- Tasks: Lead a team to ensure top-notch performance in clinical studies and site management.
- Company: Join Merck, a leader in biopharmaceutical innovation dedicated to improving patient lives.
- Benefits: Enjoy hybrid work options, travel opportunities, and a commitment to diversity and inclusion.
- Why this job: Make a real impact on healthcare while collaborating with diverse teams and industry leaders.
- Qualifications: Experience in clinical trials and management, plus a degree in Science or healthcare.
- Other info: Be part of a dynamic leadership team driving strategic initiatives in clinical development.
The predicted salary is between 43200 - 72000 £ per year.
As the Head of Site Management and Monitoring, you will make a significant impact on the success of our clinical studies and the development of our pipeline. You will be instrumental in our site management, territory development, and UK&I study support. Leading a team of CRA Managers and CRAs, you will ensure exceptional study performance whilst adhering to local regulations, Standard Operating Procedures (SOPs), and ICH Good Clinical Practice (GCP) guidelines. You will play an integral role in our UK&I Leadership team and directly influence our ability to meet the needs of patients.
What You Will Do:
- Oversee monitoring resources and assess CRA capacity to ensure high-quality monitoring deliverables across all projects.
- Lead a team of 5 CRA Managers, with responsibility for a large team of CRAs, cultivating key talent within your team and fostering a high-performance culture.
- Work closely with our Clinical Research Director, Therapy Area Leads, CRA Managers, and Vendor Management to build strong relationships with principal investigators and sites.
- Partner with vendors and internal stakeholders to develop resourcing and monitoring strategies that meet the current and future needs of our pipeline.
- Build productive collaborations with investigators, regulators, and industry partners to support clinical study execution.
- Uphold local regulations and quality standards in monitoring, while executing strategic quality initiatives to enhance operational excellence.
- Be an integral part of the local leadership team, supporting strategic initiatives across clinical development and operations.
What you will need:
- Significant experience within a pharmaceutical, clinical trial organisation in a functional management position.
- Ideally CRA experience.
- Management of CRAs and familiarity with outsourcing and flexible resourcing models.
- Bachelors degree in Science or equivalent healthcare experience.
- Ability to travel up to 30% of the time.
- Business and financial acumen with the ability to think strategically, cross-functionally and internationally.
- Ability to identify problems, conflicts and opportunities early and lead, analyse mitigation plans and drive conflict resolution.
- Excellent ICH-GCP knowledge and knowledge of Good Documentation Practices.
- A good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Contact Detail:
Merck Gruppe - MSD Sharp & Dohme Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Site Management and Monitoring (Director) - UK&I
✨Tip Number 1
Network with professionals in the clinical research field, especially those who have experience in site management and monitoring. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends in the sector.
✨Tip Number 2
Familiarise yourself with the specific regulations and guidelines relevant to the UK&I region. Understanding local compliance requirements will not only enhance your knowledge but also demonstrate your commitment to adhering to industry standards during interviews.
✨Tip Number 3
Showcase your leadership skills by discussing past experiences where you successfully managed teams or projects. Highlight your ability to cultivate talent and foster a high-performance culture, as this is crucial for the role of Head of Site Management and Monitoring.
✨Tip Number 4
Prepare to discuss your strategic thinking and problem-solving abilities. Be ready to provide examples of how you've identified issues early and implemented effective solutions, as these skills are essential for driving operational excellence in clinical studies.
We think you need these skills to ace Head of Site Management and Monitoring (Director) - UK&I
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in site management and monitoring, particularly in clinical trials. Emphasise your leadership roles and any specific achievements that demonstrate your ability to manage teams effectively.
Craft a Compelling Cover Letter: In your cover letter, express your passion for clinical research and how your background aligns with the responsibilities of the Head of Site Management and Monitoring role. Mention your understanding of ICH GCP guidelines and your strategic vision for the position.
Highlight Relevant Skills: Clearly outline your skills in people leadership, resource allocation, and quality management. Use specific examples to illustrate how you've successfully led teams and improved operational excellence in previous roles.
Showcase Your Industry Knowledge: Demonstrate your familiarity with local regulations and global clinical research guidelines. Mention any experience you have with vendor management and building collaborations with investigators, as these are crucial for the role.
How to prepare for a job interview at Merck Gruppe - MSD Sharp & Dohme
✨Showcase Your Leadership Skills
As a candidate for the Head of Site Management and Monitoring, it's crucial to demonstrate your leadership experience. Be prepared to discuss specific examples of how you've successfully led teams, managed conflicts, and cultivated talent in previous roles.
✨Understand Regulatory Standards
Familiarise yourself with local regulations, ICH GCP guidelines, and Good Documentation Practices. During the interview, be ready to explain how you have ensured compliance in past projects and how you plan to uphold these standards in the new role.
✨Highlight Your Strategic Thinking
This position requires strong business and financial acumen. Prepare to discuss how you've developed and implemented strategic initiatives in clinical development and operations, and how you can contribute to the company's goals.
✨Build Relationships
Emphasise your ability to build productive collaborations with investigators, regulators, and industry partners. Share examples of how you've successfully partnered with stakeholders to enhance clinical study execution and resource management.
