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, and opportunities for professional growth.
- Other info: Dynamic role with opportunities to collaborate across teams and manage complex projects.
- Why this job: Make a real impact in clinical research while developing your leadership skills.
- Qualifications: Bachelor's degree in life sciences or relevant experience in clinical operations.
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 employer: Kelly
As a Senior Study Operations Specialist, you will thrive in a dynamic and supportive environment that prioritises participant safety and data integrity. Our company fosters a culture of collaboration and innovation, offering ample opportunities for professional growth and development within the biotechnology sector. Located in a vibrant area, we provide a unique advantage with access to leading industry resources and a network of experts, making it an excellent place for meaningful and rewarding employment.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Study Operations Specialist
✨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. Be ready to discuss your past experiences with CROs and how you've handled escalations. We want you to shine and show that you’re the perfect fit for the role!
✨Tip Number 3
Don’t forget to showcase your problem-solving skills during interviews. Share specific examples of how you've tackled challenges in previous studies, especially when it comes to managing timelines and budgets. This will demonstrate your agility and leadership abilities.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows your enthusiasm for joining our team at StudySmarter. Let’s get you that dream job!
We think you need these skills to ace Senior Study Operations Specialist
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 managed complex situations in the past.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen on joining the StudySmarter family!
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 genuinely interested in the role.
✨Showcase Your Experience
Prepare to discuss your past experiences 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 ability to take ownership of assigned activities.
✨Communication is Key
Since strong communication and cross-functional collaboration are crucial for this role, practice articulating your thoughts clearly. Think about how you can convey complex information simply, especially when discussing your experience with training materials or presenting at meetings.
✨Be Proactive
During the interview, showcase your agility and proactive problem-solving skills. Discuss how you've identified and mitigated operational risks in previous roles. This will not only highlight your technical competencies but also show that you can think ahead and contribute positively to the team.
