At a Glance
- Tasks: Manage clinical data activities, ensuring quality and compliance in innovative research projects.
- Company: Join Coronado Research, a leader in advancing pharmaceutical research with cutting-edge technology.
- Benefits: Competitive salary, professional development, and a collaborative work environment.
- Other info: Dynamic team culture focused on innovation and ethical practices.
- Why this job: Make a real impact in clinical trials and contribute to groundbreaking medical advancements.
- Qualifications: Bachelor's degree in Life Sciences and experience in clinical data management required.
The predicted salary is between 36000 - 60000 € per year.
We are delighted to be recruiting a Clinical Data Manager to join our team at Coronado Research, working with Jo Marshall and our Data Science and Advanced Analytics team. You will need the right to work in the UK without sponsorship to be considered for this. Coronado Research is a consultancy-led, professional services organisation, which provides support to pharmaceutical, biotechnology, and medical device companies. As science changes, we are seeing the traditional clinical development model being replaced by a more targeted, precision-based approach. The introduction of new technologies, including tools leveraging Artificial Intelligence (AI) and Machine Learning, and novel methodologies is leading to a changed research paradigm.
At Coronado Research, we are dedicated to advancing pharmaceutical research through cutting-edge clinical trials, providing expert-driven advice and support. We are creating developmental processes that match the latest science, looking at the end-to-end process, optimising the research continuum, and placing data at the centre.
Role Overview
We are seeking a proactive and resourceful Clinical Data Manager to support data management activities for a variety of different clinical development programs. This role is pivotal in ensuring the integrity, quality and timeliness of clinical trial data while maintaining compliance with industry regulations. The Clinical Data Manager will support all DM activities through trial set up, conduct and lock, working with cross-functional stakeholders to ensure seamless collaboration and data accuracy.
Key Responsibilities
- Data Management Study Participation: Conduct all clinical data management activities, including data collection, validation, cleaning, medical coding and reconciliation processes.
- Data Management set-up: Contribute to the design, development, and review of Case Report Forms, Data Management and Data Review Plans and other study set up activities.
- Data Validation & Quality Control: Take responsibility for the execution of data validation activities to ensure data consistency, accuracy, and completeness, EDC checks, data listings and other data review tools to ensure data integrity.
- Vendor Data: Manage receipt and reconciliation of external data, ensuring deliverables meet quality, regulatory, and timeline expectations.
- Issue Resolution & Support: Troubleshoot data-related issues and provide hands-on support to internal and external stakeholders.
- Cross-Functional Collaboration: Work closely with clinical operations, biostatistics, and programming teams to align data management activities with overall study objectives.
- Documentation: Ensure that documentation required to demonstrate regulatory compliance are maintained accurately.
- Regulatory Compliance: Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements (FDA, EMA).
- Study Review & Reporting: Participate in data review meetings, contribute to database lock, and support clinical study report preparation.
- Industry Best Practices: Stay up to date with emerging trends and best practices in clinical data management.
Skills and Experience Required
- Bachelor's degree in Life Sciences, Biotechnology, or a related field.
- Proven experience in clinical data management within a biotech, pharmaceutical, or CRO environment.
- Hands-on expertise with key clinical data management systems.
- Knowledge of Good Clinical Practice (GCP), ICH guidelines, and global clinical trial regulations.
- Excellent logical, analytical and problem-solving skills with a creative and curious approach to help drive innovation.
- Good customer focus, able to prioritise the needs and satisfaction of our customers and deliver quality data.
- Ability to work both independently and collaboratively in a fast-paced, cross-functional environment, and to hold yourself and others to account for appropriate ethical behaviour and inclusivity.
- Dependable and a commitment to maintaining high data quality standards through a conscientious approach.
This role is ideal for a clinical data professional established with all data management activities who thrives in a collaborative environment and is passionate about advancing clinical research through high-quality data management practices.
Clinical Data Manager employer: Coronado Research
At Coronado Research, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the field of clinical research. Our commitment to employee growth is evident through continuous training opportunities and exposure to cutting-edge technologies, including AI and Machine Learning, ensuring our team remains at the forefront of the industry. Located in the UK, we provide a supportive environment where your contributions directly impact the advancement of pharmaceutical research, making your work both meaningful and rewarding.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Data Manager
✨Tip Number 1
Network like a pro! Reach out to professionals in the clinical data management field on LinkedIn or at industry events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GCP and ICH guidelines. Be ready to discuss how you’ve tackled data integrity issues in past roles – real examples will make you stand out!
✨Tip Number 3
Showcase your problem-solving skills during interviews. Think of specific challenges you’ve faced in data management and how you resolved them. This will demonstrate your analytical prowess and creativity.
✨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 you’re genuinely interested in joining our team at Coronado Research.
We think you need these skills to ace Clinical Data Manager
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Clinical Data Manager role. Highlight your experience in clinical data management and any relevant skills that match the job description. We want to see how you can contribute to our team!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical research and how your background aligns with our mission at Coronado Research. Keep it engaging and personal, so we get a sense of who you are.
Showcase Your Skills:Don’t forget to showcase your analytical and problem-solving skills in your application. Mention specific tools or methodologies you've used in past roles that relate to data management. We love seeing candidates who are proactive and resourceful!
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to submit all your documents in one go. Plus, it helps us keep track of your application!
How to prepare for a job interview at Coronado Research
✨Know Your Data Management Inside Out
Make sure you brush up on your clinical data management knowledge. Be prepared to discuss your experience with data collection, validation, and cleaning processes. Familiarise yourself with the specific tools and systems mentioned in the job description, as this will show that you're ready to hit the ground running.
✨Showcase Your Problem-Solving Skills
During the interview, be ready to share examples of how you've tackled data-related issues in the past. Think of specific challenges you've faced and how you resolved them. This will demonstrate your analytical skills and your ability to think creatively under pressure.
✨Emphasise Collaboration
Since the role involves working closely with cross-functional teams, highlight your experience in collaborative environments. Share stories about how you've successfully worked with clinical operations, biostatistics, or programming teams to achieve common goals. This will show that you can thrive in a team-oriented setting.
✨Stay Updated on Industry Trends
Make it a point to discuss any recent trends or best practices in clinical data management that you've come across. This shows your commitment to continuous learning and your passion for advancing clinical research. It also indicates that you're proactive and engaged with the evolving landscape of the industry.
