Job Description
Are you a detail-oriented leader ready to shape the future of medical research? MedTech Innovations Ltd is seeking a highly skilled Senior Clinical Data Manager to join our elite team in London. In this pivotal role, you will oversee the integrity, accuracy, and timeliness of clinical trial data, ensuring compliance with global regulatory standards.
We are a forward-thinking organization dedicated to accelerating drug development. You will work closely with cross-functional teams, including Clinical Operations, Biostatistics, and Regulatory Affairs, to drive high-quality outcomes for our diverse portfolio of life-changing therapies.
Why Join Us?
- Competitive salary and performance bonus structure.
- Hybrid working model with flexible hours.
- Comprehensive professional development and certification support.
- Access to state-of-the-art clinical data systems.
If you have a passion for data integrity and a track record of leading successful data management operations, we want to hear from you.
Responsibilities
- Lead the end-to-end clinical data management process, including planning, design, and execution of data management activities for complex clinical trials.
- Ensure strict adherence to ICH-GCP guidelines, local regulations, and internal SOPs regarding data integrity and privacy.
- Oversee the design and review of Electronic Case Report Forms (eCRFs) and data validation strategies.
- Manage a team of junior data managers and CDMs, providing mentorship, training, and performance feedback.
- Collaborate with Clinical Operations and Project Managers to resolve data queries and ensure timelines are met.
- Liaise with external vendors (CROs) and monitoring teams to ensure seamless data flow.
- Participate in protocol reviews and contribute to the master data management strategy.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field. Master’s degree is preferred.
- Minimum of 5 years of experience in Clinical Data Management, with at least 2 years in a supervisory or leadership role.
- Strong proficiency in Clinical Data Management Systems (CDMS) such as Oracle Clinical, Rave, or Medidata Rave.
- In-depth knowledge of data validation, data cleaning, and discrepancy resolution methodologies.
- Experience with Data Standards (CDISC SDTM/ADaM) and mapping tools.
- Excellent communication skills, with the ability to present complex data issues to non-technical stakeholders.
- Strong organizational skills and the ability to manage multiple priorities in a fast-paced environment.