At a Glance
- Tasks: Manage clinical trial data from start to finish, ensuring quality and compliance.
- Company: Join a leading global team in clinical research and data management.
- Benefits: Flexible remote work, competitive salary, and opportunities for professional growth.
- Other info: Dynamic work environment with potential for travel and cross-functional collaboration.
- Why this job: Make a real impact in healthcare by managing critical clinical data.
- Qualifications: 8+ years in clinical data management with strong leadership skills.
The predicted salary is between 50000 - 65000 £ per year.
We are hiring a Clinical Data Manager II or Senior Clinical Data Manager to join our global team. We can consider candidates based in the UK, Poland, Hungary, Romania, Serbia or Slovakia.
Position Summary:
The Clinical Data Manager II/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.
Essential functions of the job include but are not limited to:
- Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
- Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing.
- May perform quality control of data entry.
- Provide input, assess and manage timelines. Ensure that clinical data management deadlines are met with quality.
- May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
- Conduct database build UAT and maintain quality controlled database build documentation.
- Oversee overall quality of the clinical database.
- May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.
- Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
- Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
- Review and query clinical trial data according to the Data Management Plan.
- Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM.
- Run patient and study level status and metric reporting.
- Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency.
- Coordinate SAE/AE reconciliation.
- Liaise with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables.
- May assist with SAS programming and quality control of SAS programs used in the Data Management department.
- Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.
- May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project.
- Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities.
- May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings.
- May review Request for Proposals (RFP), proposals, provide project estimates.
- Provide leadership for cross-functional and organization-wide initiatives, where applicable.
- Train and ensure that all data management project team members have been sufficiently trained.
- Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues.
- May present software demonstrations/trainings, department/company training sessions, present at project meetings.
- May require some travel.
- Perform other duties as assigned.
Qualifications:
- Bachelors and/or a combination of related experience.
- 8+ years’ experience as a Sr. Clinical Data Manager or 5+ Years as a Clinical Data Manager II working for a Clinical Research Organisation, Pharmaceutical or Biotech company.
- Set up and Database migrations experience.
- Oncology experience preferred.
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
- Excellent organizational and communication skills.
- Professional use of the English language; both written and oral.
- Experience in utilizing various clinical database management systems.
- Broad knowledge of drug, device and/or biologic development and effective data management practices.
- Strong representational skills, ability to communicate effectively orally and in writing.
- Strong leadership and interpersonal skills.
- Ability to undertake occasional travel.
Clinical Data Manager II/Senior Clinical Data Manager employer: Precision Medicine Group
At Precision Medicine Group, we pride ourselves on being an exceptional employer, offering a collaborative and inclusive work culture that fosters professional growth and development. With opportunities for training and leadership roles, our team members are empowered to excel in their careers while contributing to meaningful projects in the clinical research field. Located across various countries including the UK, our global presence allows for diverse perspectives and innovative solutions, making it an exciting place to work.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Data Manager II/Senior Clinical Data Manager
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical data management field. Attend industry events or webinars, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for interviews by researching the company and its projects. Familiarise yourself with their data management processes and be ready to discuss how your experience aligns with their needs. We want you to shine, so practice common interview questions and have your own questions ready!
✨Tip Number 3
Showcase your skills! Bring examples of your past work, especially any database development or quality control projects you've led. We love seeing tangible proof of your expertise, so don’t hold back on sharing your successes.
✨Tip Number 4
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. We can’t wait to see what you bring to the table!
We think you need these skills to ace Clinical Data Manager II/Senior Clinical Data Manager
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Clinical Data Manager role. Highlight relevant experience, especially in data management and clinical trials, and don’t forget to mention any oncology experience if you have it!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the role and how your skills align with our needs. Keep it concise but impactful.
Showcase Your Skills:We want to see your proficiency in Microsoft Office and any clinical database management systems you've used. Be specific about your skills and how they relate to the job description.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team.
How to prepare for a job interview at Precision Medicine Group
✨Know Your Data Management Inside Out
Make sure you brush up on your clinical data management knowledge, especially around SOPs and regulatory directives. Be ready to discuss how you've managed data processes in previous roles, as this will show your expertise and confidence.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to solve hypothetical problems related to data management. Think of examples from your past experience where you successfully navigated challenges, such as database issues or quality control problems, and be prepared to explain your thought process.
✨Showcase Your Leadership Skills
As a Clinical Data Manager, you'll need to demonstrate strong leadership and interpersonal skills. Prepare to discuss how you've trained team members or led projects, highlighting your ability to communicate effectively and manage timelines.
✨Familiarise Yourself with the Company’s Projects
Research the company’s ongoing clinical trials and any specific therapeutic areas they focus on, like oncology. This will not only help you tailor your answers but also show your genuine interest in their work and how you can contribute.
