At a Glance
- Tasks: Lead clinical studies from start to finish, ensuring compliance and quality.
- Company: Join a diverse and progressive global leader in ophthalmic medical devices.
- Benefits: Competitive salary, bonuses, private medical, 25 days holiday, and wellness support.
- Other info: Access to LinkedIn Learning and extensive training for personal and professional growth.
- Why this job: Make a real impact in healthcare while developing your career in a supportive environment.
- Qualifications: Bachelor's degree in life sciences or related field; experience in clinical study management.
The predicted salary is between 36900 - 45100 £ per year.
A brighter future awaits you.
Job Summary
You’ll be responsible for the operational leadership and delivery of assigned ophthalmic medical device clinical studies throughout the study lifecycle, from concept and study design through start-up, execution, close-out and reporting. Working in close partnership with Clinical Scientists and cross-functional stakeholders, the Senior Clinical Research Associate acts as the operational study lead for assigned studies, providing expertise in study planning, site selection, budget development, vendor oversight, risk management, clinical monitoring strategy, and investigator engagement to ensure successful study delivery in compliance with GCP, SOPs and applicable regulations.
Essential Functions & Accountabilities
- Operational Study Leadership & Study Management
- Act as the operational study lead for assigned clinical studies, providing end-to-end study management from start-up through close-out and reporting.
- Lead study planning and delivery, including timelines, budgets, enrolment strategies, risk management and operational execution.
- Provide operational input into study design, protocol development, feasibility assessments and study execution strategies.
- Build strong partnerships with investigators, study coordinators, Clinical Scientists and teams across Regulatory, Quality, Legal, Procurement and Finance.
- Site, Vendor & Clinical Monitoring Oversight
- Identify, qualify, activate and oversee high-performing investigative sites.
- Develop and implement risk-based monitoring strategies and conduct site qualification, initiation, monitoring and close-out visits.
- Oversee CROs, vendors and external partners, ensuring delivery against quality, timeline, budget and contractual expectations.
- Monitor site performance, enrolment and study risks, taking timely action to resolve issues and protect participant safety and data quality.
- Quality, Compliance & Documentation
- Ensure studies are delivered in accordance with Good Clinical Practice (GCP), ISO 14155, company procedures and applicable regulatory requirements.
- Maintain inspection-ready Trial Master Files (TMFs) and essential study documentation.
- Support ethics and regulatory submissions, audits and inspections.
- Contribute to the continuous improvement of clinical processes, templates and ways of working.
Knowledge, Skills and Abilities, Experience
- Experience developing study plans, timelines, budgets, enrolment strategies and risk-management plans, including developing and managing study budgets and supporting study-related financial planning activities.
- Demonstrated experience acting as the operational lead for one or more clinical studies, with responsibility for study planning, execution, vendor oversight, budget management, risk management and study delivery.
- Strong knowledge of risk-based monitoring principles and experience developing and refining monitoring plans, including proactively identifying, assessing and mitigating study risks.
- Experience supporting ethics and regulatory submissions, clinical trial registrations, study contracting activities and investigator payments.
Education/Qualifications
- Bachelor's degree in a relevant scientific, life sciences, healthcare or clinical research discipline.
What we offer:
You’ll receive competitive compensation and a fantastic benefits package including, bonus, private medical, health cash plan, 25 days holiday, pension scheme, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more! We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours. We also provide access to LinkedIn Learning to help you develop your career and grow with CooperVision.
What you can expect:
As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering a diverse and inclusive culture is and how different perspectives add value and contribute to our success. With our CooperPride, African Descent, Woman’s Impact Network and Mind Body and Wellbeing Employee Resource Groups, we offer opportunities for employees to learn and grow within an inclusive and safe space.
If you like what you see, take the first step towards your Brighter Future and apply today! All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.
Senior Clinical Research Associate / Clinical Study Manager in Andover employer: CooperCompanies
CooperVision is an exceptional employer that prioritises the growth and wellbeing of its employees, offering a competitive benefits package including healthcare cover, a pension scheme, and access to wellness resources. Located in Mountpark, our inclusive work culture fosters collaboration and personal development, ensuring that every team member has the opportunity to thrive in their career while contributing to a brighter future for lens wearers worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Clinical Research Associate / Clinical Study Manager in Andover
✨Get Involved with Local Health Initiatives
Join local community health events or volunteer for organisations like public health agencies. This not only builds your experience but also helps you network with industry professionals who might know of openings at places like CooperCompanies.
✨Tap into Professional Associations
Check out associations like the Institute of Healthcare Management. They often have job boards, networking events, and conferences that are perfect for connecting with potential employers in health sciences administration.
✨Stay Updated with Industry Trends
Follow health policy news and trends—being knowledgeable about the current landscape will not only help you in interviews but also make you stand out as a candidate. You can discuss recent developments and their implications when chatting with folks at CooperCompanies.
✨Apply Through Our Website for Better Visibility
When you find roles that excite you, especially at places like CooperCompanies, don’t forget to apply through our website. This can sometimes give you an edge by showing the employer you’re savvy and committed to finding the right fit.
We think you need these skills to ace Senior Clinical Research Associate / Clinical Study Manager in Andover
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at CooperCompanies.
Showcase Your Administrative Skills:Administrative skills are key in this field, so don’t hold back! Make sure your CV reflects your proficiency in things like scheduling, data management, and compliance with health regulations. Mention specific software you’ve used, such as patient management systems, as this will demonstrate your hands-on abilities and readiness for the role at CooperCompanies.
Craft a Meaningful Cover Letter:Your cover letter should reflect your passion for the health sciences field and your eagerness to contribute to CooperCompanies. Share a bit about why you’re drawn to this sector, any impactful situations or challenges you’ve encountered, and how they’ve shaped your desire to work in health sciences administration. This personal touch can really set you apart!
Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at CooperCompanies. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at CooperCompanies
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
✨Prepare for Scenario Questions
Interviews for administrative roles often involve scenario-based questions to assess your problem-solving skills. Practice responses to common situations you might face, such as dealing with a challenging patient or managing a sudden schedule change. This will not only demonstrate your ability to think on your feet but also highlight your interpersonal skills.
✨Align Your Goals with the Organisation
As a full-time candidate, employers will want to know how your long-term career goals align with their mission. Take some time to research CooperCompanies’s values and be ready to tie your passion for health sciences administration into their objectives. Demonstrating enthusiasm and career alignment can be a game-changer in this competitive field!
