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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: Significant experience in clinical trials, management skills, and a relevant degree are essential.
- Other info: Be part of a dynamic leadership team driving strategic initiatives in clinical development.
The predicted salary is between 54000 - 84000 £ 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.
Head of Site Management and Monitoring (Director) - UK&I employer: Merck Gruppe - MSD Sharp & Dohme
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 and challenges 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 maintaining high standards in clinical trials.
✨Tip Number 3
Showcase your leadership skills by seeking opportunities to lead projects or initiatives within your current role. Highlighting your ability to manage teams effectively will be crucial when applying for a position that requires overseeing CRA Managers and CRAs.
✨Tip Number 4
Research StudySmarter's values and culture to align your approach during interviews. Emphasising your commitment to diversity and inclusion, as well as your ability to foster a high-performance culture, will resonate well with our leadership team.
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 align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your motivation for applying to this role. Discuss how your background in pharmaceutical or clinical trial organisations makes you a strong candidate, and mention your understanding of ICH GCP guidelines.
Highlight Leadership Experience: Since the role involves leading a team of CRA Managers and CRAs, be sure to detail your management experience. Provide examples of how you've cultivated talent and fostered a high-performance culture in previous positions.
Showcase Problem-Solving Skills: In your application, include specific instances where you've identified problems and implemented effective solutions. This will demonstrate your ability to lead and drive conflict resolution, which is crucial for this position.
How to prepare for a job interview at Merck Gruppe - MSD Sharp & Dohme
✨Showcase Your Leadership Skills
As the role involves leading a team of CRA Managers and CRAs, it's crucial to demonstrate your leadership experience. Prepare examples of how you've successfully managed teams, cultivated talent, and fostered a high-performance culture in previous roles.
✨Understand Regulatory Standards
Familiarise yourself with local regulations, SOPs, and ICH GCP guidelines. Be ready to discuss how you have ensured compliance in past projects and how you plan to uphold these standards in the new role.
✨Highlight Your Strategic Thinking
The position requires business and financial acumen along with strategic thinking. Prepare to discuss how you've identified problems and opportunities in previous roles and the strategies you implemented to address them.
✨Build Relationships
Since collaboration with investigators, regulators, and industry partners is key, be prepared to share examples of how you've built strong relationships in your past roles. This will show your ability to work effectively with various stakeholders.
