Currently looking for a Data Quality Lead/ Clinical Data Scientist for a large blue chip pharmaceutical company at their Middelsex facility.
Assist with the oversight of CRO conducting the following activities: define, build & test database (eCRF) define, build & test data validation checks, data entry and clean-up (queries, coding, reconciliations) and delivery of clean datasets for analysis and reporting.
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.
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.
The successful candidate will be:
- Degree qualified
- Experience in Rare Diseases, Gene Therapy, Academic Research Organisations,
- Possesses highly effective interpersonal skills with excellent written and verbal communications.
- Demonstrated leadership skills within a matrix environment; ability to influence and negotiate with stakeholders to identify win/win solutions.
- Ability to apply scientific knowledge, previous experience and curiosity, to identify risks to data integrity and implement mitigation plans to maximise data evaluability.
- CDISC and working with eDC tools (InForm).
Please apply online or for more information please call Paul on 0161 942 4035