Data Quality Lead
CK Group is currently recruiting for a Data Quality Lead to join a global Pharmaceutical company for a 12 month contract. The role will be based in Uxbridge and will then move to Brentford in March 2020. Hourly rate is £41.50 LTD company. There is no remote working with this role, fully site based.
As a global healthcare company, they take on some of the world's biggest healthcare challenges. By delivering a sustainable business, they provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. They have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. They are committed to widening access to their products, so more people can benefit, no matter where they live in the world or what they can afford to pay.
Stockley Park was the UK's first and most successful business park. Situated close to Heathrow Airport in West London, it is home for roles within clinical safety, clinical data, conversion leads, programming, regulatory and more. It's a location that combines excellent transport links with the M4 and M25 motorways and Heathrow Airport a few minutes away. A choice of railway and tube stations, extensive bus networks plus ample parking provides a coordinated transport hub to connect to the park.
Key Responsibilities for this role will include:
- Primary responsibility will be to 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.
- 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.
- Highly organised with ability to prioritise work and remain focused on objectives in rapidly changing circumstances.
- 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 (RAVE).
- Conversant with the clinical trial environment, study design, and the bigger picture of drug development.
- Ability to think outside the box within the confines of company procedures, and industry and regulatory requirements.
- Demonstrated effective oversight of outsourced activities.
For more information or to apply for this role, please contact Julie Marshall on 01438 768 710 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46134 in all correspondence.