Principal Clinical Data Scientist

Basic qualifications: 

• Life science Bachelors degree or equivalent.
• Expert understanding of ICH/GCP as applicable to data management.
• 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.
• Prior data management experience gained in Pharma, CRO and/or ARO’s with demonstrated expertise in oversight of data management service providers.

Preferred qualifications: 

• 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.
• Understanding the tools of the trade including systems and data standards (CDISC/SDTM)

Details: 

We are a science-led global healthcare company. Our operating model and our business model both are designed to support us in our mission. 
We are focused around three core businesses: Pharmaceuticals, Vaccines and GSK Consumer Healthcare. 
We have a significant global presence with commercial operations in more than 150 countries, a network of 84 manufacturing sites in 36 countries and large R&D centres in the UK, US,  Belgium and China.

The data quality lead (DQL) role sits at the intersection of clinical data and study delivery and is accountable for data quality of studies starting from study design through data acquisition, site activities, monitoring, database freeze/lock, archiving and reporting.  

• Accountable for data quality within single studies and/or across multiple studies within the project.
• Lead study and project teams in the delivery of high quality data to support the reporting of studies. 
• Input in to clinical trial designs (study protocols), using scientific expertise and logical aptitude to highlight and mitigate risks to data quality potentially impacting study objectives. Translating the protocol into specifications for all data types.
• Selection and management of external data providers (e.g CROs, Labs) to ensure delivery to agreed quality, standards, budget and timelines.
• With the study team, define and implement risk based monitoring (RBM) to manage risks to data integrity & quality and to protect the subjects’ rights and wellbeing.
• Close collaboration with investigational sites and monitors around the world in the setup conduct and delivery of clinical trial data to the highest quality.
• Utilisation of data visualisation tools to identify scientifically unfeasible or anomalous data and taking appropriate action to prevent or minimise reoccurrence.
• Accountable for the full life cycle of the data management artefacts of the Trial Master File(TMF).
• 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 

If requiring an adjustment for a disability, once selected for interview you may contact ukdiversity.recruitment@gsk.com

Please indicate within your cover letter if you are confirmed as displaced (or potentially displaced) and at risk of redundancy.

Closing Date: 20th October  2016

*LI-GSK

Contact information: 

You may apply for this position online by selecting the Apply now button.