Beschreibung
Lead Site Manager
Location: United Kingdom
At Johnson & Johnson, our guiding principle is that health is paramount. Leveraging our extensive expertise in healthcare innovation, we are devoted to creating a future where complex diseases are effectively prevented, treated, and cured. Our commitment leads to the development of treatments that are not only smarter and less invasive but also personalized to meet individual patient needs. With our profound knowledge spanning Innovative Medicine and MedTech, we are strategically positioned to innovate across the entire spectrum of healthcare solutions. This ensures that we can deliver transformative breakthroughs that will significantly enhance health outcomes for humanity. Discover more about our mission and initiatives at
We are in search of a Lead Site Manager who will act as the key liaison between the Sponsor and the Investigational Site for clinical trials in phases 2 through 4. Within different settings, the Site Manager might be referred to as a Clinical Research Associate or Monitor. Our head office, located in High Wycombe, Buckinghamshire, will serve as a hub, while this role allows for home-based flexibility. We have openings in multiple therapeutic areas; candidates with a background in Haematology Oncology are especially encouraged to apply, though experience in Solid Oncology or Immunology is also valuable.
In your capacity as a Lead Site Manager, you will be tasked with maintaining readiness for inspections and ensuring compliance with clinical trial protocols, Standard Operating Procedures (SOP), and Good Clinical Practice (GCP). This adherence extends to regulations from the commencement of the study until site closure. Ideal candidates will possess adaptability and the capability to work autonomously. We are looking for exceptional communicators who are proactive learners, adept problem solvers, and true team players. You will oversee clinical trial protocols at the site level, collaborating closely with a Local Trial Manager (country project manager), Clinical Trial Assistant, and Trial Delivery Manager (regional project manager) to achieve our clinical objectives.
You will immerse yourself in a dedicated and passionate study team, driven to make meaningful improvements in the lives of millions of patients around the globe. Additionally, you’ll be part of a broader UK team that fosters mutual support and strives to uncover new, more efficient ways of working together to enhance trial outcomes.
Principal Responsibilities:
- Your role encompasses a broad array of responsibilities including site feasibility assessments, site selection, initiation and start-up processes, and overseeing the preparation and execution of site monitoring activities. You will also monitor key performance indicators and lead site/study close-out processes for complex clinical trials.
- A critical function of your role will involve implementing a site-level analytical risk-based monitoring model and collaborating with site staff to ensure the swift resolution of any concerns or deviations discovered during monitoring visits.
- Ensure the precision and thoroughness of all trial data, including crucial safety data. You will manage the timely entry of data and address any discrepancies in partnership with the site staff.
- Collaborate to develop targeted site-level recruitment and retention strategies while actively implementing mitigation measures in conjunction with other functional departments.
- Maintain comprehensive documentation of trial-related activities across all study files, proactively communicating site and study progress, as well as any issues, to the Local Trials manager and central study teams.
- Establish yourself as the local authority on assigned protocols, acquiring the necessary therapeutic area knowledge to excel in your role.
- Mentor and coach less experienced colleagues; assist the Manager of Clinical Operations with onboarding new hires and integration into the team.
- Engage in process improvements and training initiatives, leading or participating in special projects or assignments as they arise. You may take on additional responsibilities or specialized initiatives, such as ‘Champion’ or ‘Subject Matter Expert’.
- Support the development of site managers and collaborate with the compliance team to implement training and enhancements.
Befähigungen
Education and Experience Requirements:
- A bachelor’s degree (BA/BS) in Life Sciences, Nursing, or a closely related scientific discipline is required, or equivalent professional experience will be considered.
- A minimum of seven years of clinical trial monitoring experience is highly preferred, although the hiring manager may consider other relevant work experiences and skills.
- Knowledge across various therapeutic areas will be regarded as an asset that enhances your candidacy.
- Demonstrated understanding of GCP, local laws, and regulations governing clinical trials is essential.
- Strong IT skills are necessary, along with proficiency in operating various systems and databases pertinent to clinical research.
- You should be able to effectively implement and maintain a home office setup conducive to your role.
- The ideal candidate will be a dynamic team player, a self-starter, and demonstrate the ability to work independently with minimal supervision.
- Strong communication and influencing abilities are crucial for effectively managing study sites both remotely and through in-person interactions.
- A willingness to travel up to 50% of the time, which may include 2-3 days per week of overnight stays when required, is expected.
Benefits:
We provide a competitive salary complemented by a comprehensive benefits package. Ensuring the health and well-being of our employees is a priority; we promote a flexible working environment that values work-life balance. Additionally, we offer career advancement opportunities for those looking to grow and become integral members of our organization. Join us at Janssen!
Johnson & Johnson Family of Companies is committed to equal opportunity employment. All qualified applicants will be considered for employment regardless of any characteristic protected by law.
We pledge to accommodate individuals with disabilities by providing reasonable adjustments that facilitate their participation in the job application or interview process, and to assist them in performing essential job functions and enjoying other employment benefits. Please contact us to request any necessary accommodations.
What are the key responsibilities of a Lead Site Manager at Johnson & Johnson during clinical trials?
**Interview with Johnson & Johnson Lead Site Manager**
**Host**: Welcome to our program! Today, we have the pleasure of speaking with Dr. Sarah Thompson, a Lead Site Manager at Johnson & Johnson. Sarah, thank you for joining us.
**Sarah**: Thank you for having me! It’s great to be here.
**Host**: Let’s dive right in. Can you tell us about your role as a Lead Site Manager and what it entails?
**Sarah**: Absolutely! As a Lead Site Manager, I act as the key liaison between the Sponsor and the Investigational Site for clinical trials, specifically in phases 2 through 4. My responsibilities include site feasibility assessments, initiation processes, and overseeing site monitoring activities. I ensure that our trials comply with protocols and Good Clinical Practice (GCP) from the very start of the study until we close the site.
**Host**: That sounds crucial for the integrity of clinical trials. What qualities do you think are essential for someone in this role?
**Sarah**: Great question! Adaptability is vital, as the landscape can change quickly. I also believe strong communication skills are essential. You need to be able to collaborate effectively with various team members, from the Local Trial Manager to the site staff. Being a proactive learner and problem solver is key, as we often encounter challenges that require thoughtful, timely responses.
**Host**: You mentioned working with a dedicated study team. How important is teamwork in your role?
**Sarah**: It’s incredibly important! Our mission is to make meaningful improvements in the lives of millions, and that requires a cohesive effort. We rely on support from our UK team and collaborate closely to find better ways of working together, which ultimately enhances our trial outcomes.
**Host**: What challenges do you face in maintaining compliance and readiness for inspections?
**Sarah**: One of the biggest challenges is ensuring that all trial data is precise and thorough. During inspections, all processes must be documented meticulously. Furthermore, I implement a site-level risk-based monitoring model to identify and resolve any deviations as they arise. Keeping a close eye on performance indicators and maintaining open lines of communication with the study team is crucial.
**Host**: It seems like a dynamic role with a lot of responsibility. What background or experience do you think is important for someone wanting to pursue this career path?
**Sarah**: Generally, a bachelor’s degree in Life Sciences, Nursing, or a related field is required. Beyond that, a strong clinical trial monitoring background—ideally seven years or more—is highly preferred. Understanding various therapeutic areas, like Haematology Oncology, can also enhance your candidacy significantly.
**Host**: what do you find most rewarding about your job?
**Sarah**: The most rewarding part is knowing that the work we do can lead to life-changing treatments for patients. Being part of a passionate team that strives to innovate and improve health outcomes is truly fulfilling.
**Host**: Thank you so much for sharing your insights, Sarah. It’s inspiring to hear about your important work at Johnson & Johnson.
**Sarah**: Thank you for having me! It was a pleasure.