[ad_1] Location: Stadium House, White City campus (hybrid) Job Summary We are looking for a new Principal Data Manager to support an e
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Location: Stadium House, White City campus (hybrid)
Job Summary
We are looking for a new Principal Data Manager to support an exciting project exploring use of real-world data in clinical trials. The project is funded by a MRC grant “Meeting global need to improve newborn care through real-world-health-data-facilitated, digital-technology-supported randomised clinical trials”, held by Professor Neena Modi, Professor of Neonatal Medicine.
Based within the School of Public Health at Imperial College London, the Imperial Clinical Trials Unit (ICTU) works to bring together academic and trial management expertise. Trial designs range from early stage to large confirmatory studies, with a focus currently on a number of therapeutic areas including neonatal medicine, cancer, cardiovascular, metabolic and respiratory disease, emergency medicine and critical care, HIV and infectious diseases, surgery and hepatology.
The project this role will support has the following objectives:
- To establish globally unique, high-value, collaborative capability for efficient, cost-effective, randomised controlled trials (addressing clinical practice uncertainties and clinical trials of investigational medicinal products, both academic and industry-sponsored) in neonatal populations, in which all or the majority of data are obtained from a well-established repository of real-world clinical data, the National Neonatal Research Database (NNRD-RCT)
- To maximise use of digital technologies
- To employ novel, efficient trial designs
- To achieve high-impact through strong stakeholder understanding and trust in the new processes and creation of a pipeline for collaborative NNRD-RCT
This Principal Data Manager position is a key role within ICTU, ensuring that the full spectrum of data management activities is conducted to the highest scientific, ethical, and regulatory standards.
Duties and responsibilities
You will be responsible for establishing a standard approach to working with routinely collected/real world data, principally the National Neonatal Research Database, including linking these with the OpenClinica Electronic Data Capture system and liaising with relevant teams to ensure data integrity is maintained. You will work closely with the staff of the Neonatal Data Analysis Unit at the Chelsea and Westminster Hospital campus where the National Neonatal Research Database is located and managed.
You will be responsible for ensuring all data management activities within the trial lifecycle from protocol and study database creation to data cleaning, quality-assurance and validation for research studies are completed to the highest standard in accordance with the approved clinical trial protocol, for a variety of different studies, phases and therapeutic areas. In addition, you will provide expert advice on all data management activities.
Essential requirements
You will need:
- A degree or equivalent in biomedical/scientific/statistical/computer science or relevant subject and / or relevant experience.
- Significant proven experience in Clinical data management, covering the full trial cycle of data management activities in a clinical trial setting.
- Previous experience gained working within an Academic Clinical Trials Unit, Pharmaceutical, CRO or a Biotech company.
- Team management experience; manager to direct reports, including team building, staff development and performance appraisal experience.
- Ability to effectively lead a team, identifying the work required and how to organise, facilitate or perform the work, delegating to other team members as appropriate.
Further Information
This post is full-time, fixed term for 14 months in the first instance and is available immediately.
For an informal discussion about the post please contact Amanda Bravery, a.bravery@imperial.ac.uk
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