At a Glance
- Tasks: Lead and support clinical study operations, ensuring participant safety and data integrity.
- Company: Join a leading biotechnology firm dedicated to innovative health solutions.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Dynamic role with opportunities to collaborate across teams and enhance your leadership skills.
- Why this job: Make a real difference in healthcare by managing impactful clinical studies.
- Qualifications: Bachelor’s degree in life sciences preferred; experience in clinical operations is a plus.
The predicted salary is between 50000 - 65000 £ per year.
The Senior Study Specialist supports and, at times, leads operational activities for clinical studies, with a focus on site oversight, vendor management, and study execution. Working closely with the Study Manager or Program Lead, this role helps ensure participant safety, data integrity, study quality, timelines, and budget adherence. The position requires a high level of independence, experience managing complex vendors, sites, and regions, and the ability to effectively handle escalations and key investigator relationships.
Key Responsibilities
- Support and develop study-specific documentation as delegated by study leadership.
- Contribute to feasibility assessments, site selection, and site start-up activities.
- Provide oversight of CRO activities, including IRB/EC submissions and approvals.
- Manage essential documents across the study lifecycle, including oversight of the Trial Master File (TMF).
- Develop, oversee, and deliver site and investigator training materials.
- Present at investigator meetings when assigned.
- Ensure accurate and timely updates to clinical trial registries (e.g., ClinicalTrials.gov).
- Facilitate and track screening authorization documentation where applicable.
- Coordinate document execution using electronic signature systems.
- Oversee clinical trial insurance documentation.
- Represent Global Study Operations in cross-functional, vendor, and study execution meetings; document and distribute meeting minutes as needed.
- Contribute to identification and mitigation of operational risks.
- Provide administrative and logistical support for internal and external meetings.
Core Competencies
- Agility and proactive problem-solving
- Leadership and ownership of assigned activities
- Strong communication and cross-functional collaboration
Technical Competencies
- Clinical study management and execution
- Compliance and quality oversight
- Understanding of drug development and study design
- Product and therapeutic area knowledge
Education & Experience
- Bachelor’s degree or higher in nursing, life sciences, or health sciences preferred (relevant industry experience may be considered in lieu of formal education).
- Experience in biotechnology or pharmaceutical clinical operations.
- Demonstrated experience overseeing external vendors, including contracts/SOWs, budgets, purchase orders, and invoice management (e.g., CROs, central labs, imaging vendors).
Senior Study Operations Specialist in City of London employer: Kelly
As a Graduate Manufacturing Engineer at our globally recognised power systems manufacturer in Darlington, you'll be part of a dynamic team that values innovation and excellence. We offer a supportive work culture that prioritises employee growth through mentorship and hands-on experience, alongside competitive benefits and opportunities for international collaboration. Join us to make a meaningful impact in a world-class engineering environment where your contributions are valued and rewarded.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Study Operations Specialist in City of London
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical operations field and let them know you're on the hunt for a Senior Study Operations Specialist role. 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 brushing up on your knowledge of clinical study management and vendor oversight. Be ready to discuss your experience with site selection and how you've handled escalations in the past. We want to see that you can bring your A-game!
✨Tip Number 3
Showcase your leadership skills during interviews. Talk about times when you've taken ownership of projects or led teams through challenges. This is key for a role that requires agility and proactive problem-solving, so make sure we see that side of you!
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows us that you're genuinely interested in joining our team at StudySmarter.
We think you need these skills to ace Senior Study Operations Specialist in City of London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Study Operations Specialist role. Highlight your experience in clinical studies, vendor management, and any relevant skills that match the job description. We want to see how you can bring your unique flair to our team!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Share specific examples of your past experiences that align with the responsibilities listed in the job description. Let us know what makes you tick!
Showcase Your Problem-Solving Skills:In your application, don’t forget to highlight your agility and proactive problem-solving abilities. We love candidates who can think on their feet and tackle challenges head-on. Share stories that demonstrate how you've successfully navigated complex situations in the past.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates. Plus, it’s super easy – just a few clicks and you’re done!
How to prepare for a job interview at Kelly
✨Know Your Stuff
Make sure you brush up on clinical study management and execution. Familiarise yourself with the specifics of vendor management and site oversight, as these are crucial for the role. Being able to discuss your past experiences in these areas will show that you're ready to hit the ground running.
✨Show Your Problem-Solving Skills
Prepare examples of how you've tackled challenges in previous roles. This position requires agility and proactive problem-solving, so think of situations where you identified risks and implemented solutions. Sharing these stories will demonstrate your leadership and ownership capabilities.
✨Communicate Clearly
Strong communication is key in this role, especially when dealing with cross-functional teams and external vendors. Practice articulating your thoughts clearly and concisely. You might even want to prepare a few questions to ask during the interview to show your engagement and interest.
✨Get Familiar with the Company
Research the company’s recent projects and their approach to clinical studies. Understanding their values and how they align with your own can help you tailor your responses. Plus, it shows that you’re genuinely interested in being part of their team.
