At a Glance
- Tasks: Lead and support clinical study operations, ensuring participant safety and data integrity.
- Company: Join a leading biotechnology firm focused on innovative health solutions.
- Benefits: Competitive salary, health benefits, flexible working options, and career development opportunities.
- Other info: Dynamic role with opportunities for growth in a collaborative environment.
- Why this job: Make a real impact in clinical research while developing your leadership skills.
- 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 Slough 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 Slough
✨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 study management and vendor oversight. We recommend practising common interview questions related to site selection and risk mitigation, so you can showcase your expertise and confidence when it counts.
✨Tip Number 3
Don’t forget to leverage our website for job applications! It’s super easy to apply directly through us, and we often have exclusive listings that you won’t find elsewhere. Plus, it shows you’re serious about joining our team!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in leaving a positive impression. Mention something specific from your conversation to remind them why you’re the perfect fit for the Senior Study Operations Specialist role.
We think you need these skills to ace Senior Study Operations Specialist in Slough
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that match the Senior Study Operations Specialist role. Highlight your experience with clinical studies, vendor management, and any relevant operational activities to show us you’re the right fit.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to tell us why you're passionate about clinical operations and how your background aligns with our mission at StudySmarter. Be sure to mention any specific projects or achievements that demonstrate your expertise.
Showcase Your Problem-Solving Skills:In your application, don’t forget to highlight instances where you've tackled challenges in study management or vendor oversight. We love seeing candidates who can think on their feet and come up with creative solutions!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status. Plus, we love seeing applications come in through our own platform!
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 specific responsibilities of a Senior Study Operations Specialist, especially around vendor management and site oversight. This will help you answer questions confidently and show that you're ready to hit the ground running.
✨Showcase Your Experience
Prepare to discuss your past experiences in managing complex vendors and sites. Have specific examples ready that highlight your problem-solving skills and how you've handled escalations or built key investigator relationships. This will demonstrate your independence and leadership capabilities.
✨Be Ready for Scenario Questions
Expect scenario-based questions that assess your agility and proactive problem-solving skills. Think about potential operational risks in clinical studies and how you would mitigate them. This shows that you can think on your feet and are prepared for real-world challenges.
✨Communicate Clearly
Strong communication is key in this role. Practice articulating your thoughts clearly and concisely, especially when discussing technical competencies like compliance and quality oversight. Being able to convey complex information simply will impress your interviewers and showcase your collaboration skills.
