At a Glance
- Tasks: Manage clinical trial data to ensure accuracy and quality for patient outcomes.
- Company: Perspectum Ltd, a leader in medical data management.
- Benefits: Tailored training, career growth, and a chance to impact patient care.
- Other info: Diverse and inclusive workplace with opportunities for personal development.
- Why this job: Make a real difference in healthcare by improving clinical data quality.
- Qualifications: Degree in Life Sciences or Data Science; attention to detail is key.
The predicted salary is between 30000 - 42000 £ per year.
Job Overview
- EDC data entry and review.
- Generating data queries and performing data validation on reconciliation.
- Assist with database lock requests.
- Monitor the progress of data cleaning activities and the quality of the data.
- Assist in database design, set up, testing and maintenance.
- Assist with Data Transfer Agreements and Data Management Plan drafting.
- Manage EDC access.
- Database design, set up, testing and maintenance.
- Ensure CDM activities conform to ICH GCP guidance.
- Lead and/or participate in internal and external audits of clinical data management processes.
Essential
- EDC data entry and review.
- Generating data queries and performing data validation on reconciliation.
- Assist with database lock requests.
- Monitor the progress of data cleaning activities and the quality of the data.
- Assist in database design, set up, testing and maintenance.
Job Overview
The Clinical Data Manager I is responsible for ensuring that clinical trial data is accurate, complete, and consistent with study protocol, standard operating procedures (SOPs), and regulatory requirements. They work closely with cross-functional teams, including clinical operations, biostatistics, and medical writing, to support the collection, management, and analysis of clinical trial data. They are a detail-oriented individual with a passion for clinical research and data management.
Essential
Duties and Responsibilities
- EDC data entry and review.
- Generating data queries and performing data validation on reconciliation.
- Assist with database lock requests.
- Monitor the progress of data cleaning activities and the quality of the data.
- Assist in database design, set up, testing and maintenance.
- Assist with Data Transfer Agreements and Data Management Plan drafting.
- Manage EDC access.
- Database design, set up, testing and maintenance.
- Ensure CDM activities conform to ICH GCP guidance.
- Lead and/or participate in internal and external audits of clinical data management processes.
Desirable
- Assist with Data Transfer Agreements and Data Management Plan drafting.
- Manage EDC access.
- Database design, set up, testing and maintenance.
- Oversee/execute database lock requests.
- Ensure CDM activities conform to ICH GCP guidance.
- Lead and/or participate in internal and external audits of clinical data management processes.
Person Specification
Essential
- Bachelor’s degree in a relevant field (i.e., Life Sciences, Engineering, etc)
- Strong organisation and prioritising skills with ability to meet multiple deadlines.
- Excellent attention to detail and accuracy.
- Excellent communication and collaboration skills.
- Passion for working with data / clinical research / clinical trials
Desirable
- Advanced degree in a relevant field (i.e. Life Sciences, Engineering, etc)
- Certificate in Good Clinical Practise (GCP).
- Experience in CDM and knowledge of effective clinical data management practices.
- Knowledge of effective clinical data management practices.
- Experience working with Clinical Data Management and Electronic Data Capture (EDC) systems.
- Knowledge of Good Clinical Data Management Practices (GCDMP) and CDISC Study Data Tabulation
- Model (SDTM) standards.
- Experience within Medical Devices/Pharma/Clinical industry.
- Strong project and resource management skills with ability to manage multiple projects.
- Experience working with Quality Framework (ISO) standards (e.g.ISO27001, ISO13485) and ICH GCP,
- and understanding of 21 CFR Part 11 regulation.
- Proactive, analytical, and problemsolving skills with commitment for continuous improvement.
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Clinical Data Manager I in Oxford employer: Perspectum Ltd
Perspectum Ltd is an excellent employer, offering a dynamic and inclusive work culture in the heart of Oxford. Employees benefit from comprehensive training opportunities and a commitment to professional growth, all while contributing to meaningful advancements in medical device compliance. The collaborative environment fosters innovation and values each individual's contributions, making it a rewarding place to build a career.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Data Manager I in Oxford
✨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 open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by practising common questions related to clinical data management. Think about how your skills in attention to detail and problem-solving can shine through. We want you to feel confident and ready to impress!
✨Tip Number 3
Showcase your passion for improving patient outcomes during interviews. Share any relevant projects or experiences that highlight your commitment to clinical research and data management. Let them see your enthusiasm!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Clinical Data Manager I in Oxford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the Clinical Data Manager I role. Highlight any relevant coursework or projects in Life Sciences or Data Science, and don’t forget to mention your attention to detail!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Share your passion for clinical research and how you can contribute to improving patient outcomes. Be genuine and let your enthusiasm for the role come through.
Showcase Your Skills:If you have experience with EDC systems, SQL, or Python, make sure to include that in your application. Even if it’s just basic knowledge, it shows your commitment to learning and growing in this field.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands and shows us you’re serious about joining our team!
How to prepare for a job interview at Perspectum Ltd
✨Know Your Data
Before the interview, brush up on your knowledge of clinical data management and the specific responsibilities of a Clinical Data Manager I. Familiarise yourself with Electronic Data Capture (EDC) systems and be ready to discuss how you would ensure data accuracy and completeness.
✨Showcase Your Attention to Detail
During the interview, highlight examples from your academic or work experience where your attention to detail made a difference. Whether it’s tidying datasets or validating data, demonstrating this skill will resonate well with the interviewers.
✨Communicate Clearly
As an excellent communicator, practice articulating your thoughts clearly and concisely. Be prepared to explain complex concepts in simple terms, especially when discussing data management principles or your understanding of clinical trials.
✨Express Your Passion for Patient Outcomes
Make sure to convey your enthusiasm for improving patient outcomes through your work. Share any relevant experiences or projects that showcase your commitment to clinical research and how you see your role contributing to meaningful change.
