Contract Data Quality Lead
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A top 10 global pharmaceutical company is currently recruiting a Contract Data Quality Lead. This organisation develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory, and employs 100,000 staff globally. Based in the company's office in West London, this position offers an exciting opportunity to work with an internationally renowned company and bolster a career in the clinical field.
The role's primary responsibility will be to assist with the oversight of CRO by defining, building, and testing databases (eCRF), defining, building, and testing data validation checks, data entry, and clean-up (queries, coding, reconciliations), and overseeing the delivery of clean datasets for analysis and reporting.
Job Responsibilities:
- Lead study and project teams in the delivery of high-quality data to support the reporting of early phase clinical pharmacology studies.
- Close collaboration with investigational sites and monitors around the world in the setup conduct and delivery of clinical trial data to the highest quality. Provide data management input to the protocol and translating the protocol into specifications for all data types.
- Utilisation of data visualisation tools to identify scientifically unfeasible or anomalous data and taking appropriate action to prevent or minimise reoccurrence.
- In partnership with study team, responsible for delivery of data management contributions to regulatory submissions when required.
- As necessary, identify, participate and/or lead process improvement initiatives.
- Train, coach and mentor staff as required completion of specific project goals and objectives in accordance with defined quality and time-based metrics.
Skills and Requirements:
- Experience would be preferred in any of the following: rare diseases, gene therapy, working with Academic Research Organisations (AROs), CDISC and working with eDC tools.
- Conversant with the clinical trial environment, study design, and the bigger picture of drug development.
- Demonstrated effective oversight of outsourced activities.
- The role requires expert data management experience in the whole lifecycle of a clinical trial from database set-up to database lock, sound knowledge of ICH-GCP and good organisational skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Emma Adams at +44 203 854 3893 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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