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- Tasks: Lead data management operations for clinical trials, ensuring quality and timely project execution.
- Company: Join a leading global development team focused on innovative healthcare solutions.
- Benefits: Attractive salary, flexible working options, and opportunities for professional growth.
- Other info: Collaborative culture with a focus on innovation and continuous improvement.
- Why this job: Make a real impact in clinical research while developing your skills in a dynamic environment.
- Qualifications: 8+ years in clinical data management with strong project management skills.
The predicted salary is between 60000 - 80000 £ per year.
By acting as the primary Data Management (DM) representative to the study management team, the DM Operations Lead partners with the Data Management Portfolio Lead and key study/program team members to develop and implement project plans for assigned studies, ensuring the functional activities are completed by vendors according to specified quality standards and timelines, and for coordinating ongoing data management activities with vendors to support the flawless execution of a clinical trial. May support special initiatives both inside and outside the Data Management department.
Uses phase, TA and operational knowledge to establish and implement study level operational plans and oversees vendors to ensure on time project delivery on all assigned projects. Develops study level quality/oversight plans and ensures adherence and consistent execution across the data flow. Collaborates with DM Portfolio Leads to ensure alignment of study operational plans with program goals. Contributes to and/or accountable to update and manage study dashboards, timelines, resource prioritisation, and data deliverables.
- Accountable for development of timelines, project management of all end to end data management deliverables in collaboration with cross functional team members and vendors on assigned studies.
- Single point of contact for the execution of data management deliverables on assigned trials/programs. Interprets and applies data strategy, ensures use of global/program standards, coordinates and oversees outsourced personnel, and monitors and reports on overall study progress.
- Accountable for overall consistency of DM standards across assigned trials/program and quality/integrity of the data. Ensures high utilisation of standards library components (e.g. eCRFs, Edit checks).
- Develops risk mitigation or action plans and oversees execution when appropriate.
- Reviews performance metrics and trends for DM deliverables on assigned studies/programs and ensures most optimal execution. Reports/Escalates issues/risks to Portfolio Lead.
- Primary contact between DM and clinical study management teams (SMT). Liaises directly with internal customers (Biometrics functions, Clinical, Medical, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel).
- Contributes to the development of DM process, data collection and management, reporting, and process improvement and innovation as needed.
- Manages performance and quality issues with vendors (FSP and 3rd party data providers such as labs) and escalates to DM Portfolio Lead, DM management. Develops appropriate risk mitigation, as needed.
- Supports study-level/drug program audit and inspection readiness activities as needed.
- Supports special projects and initiatives; partners with Statistical Programming, Biostatistics, Vendor Management, and Quality as well as Global Development depending on type of project.
Qualifications: 8+ years relevant work experience with a focus on clinical data management, 4+ years as a Trial Data Manager with full accountability across study start-up, conduct, and lock. Robust experience with Medidata Rave and use of Data Review tools.
The Data Management Operations Lead manages the end to end clinical data flow (data acquisition from Case Report Form (CRF) development to Clinical Study Reporting (CSR) of Clinical Data) and ensures timely project execution, quality data deliverables, and prioritisation of all DM milestone delivery. Recognised as an operational specialist in clinical data flow and study execution by all functions across Global Development.
Data Management Operations Lead in Maidenhead employer: Biogen SANDBOX
Contact Detail:
Biogen SANDBOX Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Data Management Operations Lead in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and understanding their data management processes. We recommend practising common interview questions and even role-playing with a friend. The more prepared you are, the more confident you'll feel when it’s time to shine!
✨Tip Number 3
Showcase your skills! Create a portfolio or a presentation that highlights your past projects and successes in data management. We love seeing tangible evidence of your expertise, so don’t be shy about sharing your achievements during interviews.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we often have exclusive opportunities listed there that you won’t find anywhere else. So, don’t miss out – get your application in today!
We think you need these skills to ace Data Management Operations Lead in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Data Management Operations Lead role. Highlight your relevant experience in clinical data management and any specific tools you've used, like Medidata Rave. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about data management and how your background makes you a perfect fit for our team. Keep it engaging and personal – we love to see your personality come through!
Showcase Your Project Management Skills: Since this role involves managing timelines and deliverables, be sure to highlight your project management experience. Share specific examples of how you've successfully led projects in the past, especially in clinical settings. We want to know how you keep things on track!
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 StudySmarter!
How to prepare for a job interview at Biogen SANDBOX
✨Know Your Data Management Inside Out
Make sure you brush up on your clinical data management knowledge, especially around Medidata Rave and data review tools. Be ready to discuss how you've managed data flow in previous roles and how you ensure quality standards are met.
✨Showcase Your Project Management Skills
Prepare examples of how you've developed and implemented project plans in the past. Highlight your experience with timelines, resource prioritisation, and how you’ve coordinated with vendors to ensure on-time delivery.
✨Be Ready for Scenario Questions
Expect questions that ask you to solve hypothetical problems related to data management operations. Think about risk mitigation strategies you've used before and be prepared to explain how you would handle performance issues with vendors.
✨Demonstrate Your Collaborative Spirit
Since this role involves liaising with various teams, be prepared to discuss how you've successfully collaborated with cross-functional teams in the past. Share specific examples of how you’ve worked with clinical study management teams or other departments to achieve common goals.