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Clinical Data Manager

Job title: Clinical Data Manager
Contract Type: Permanent
Location: Cheshire, England
Industry:
Salary: Competitive + share options
Reference: BH-123197
Contact Name: Lisa Kitt
Phone Number: 07539 074151
Job Published: 7 days ago

Job Description



We are pleased to be working with an expanding and forward thinking Biotechniology company based in Cheshire, to recruit for a Clinical Data Manager,  responsible for managing the data management tasks for a programme of studies from study start up to database lock. The Clinical Data Manager will perform or oversee the technical set-up, maintenance and close out activities for all Data Management aspects on a project.  They will also perform the data management handling and coding resulting in quality data for assigned clinical trials on behalf of the business. 




Key Accountabilities/Responsibilities include
  • Work closely with a wide range of clients and internal colleagues to provide support to assigned clinical trials on behalf of the business
  • Support the set up and management of the company data capture (EDC) tools and systems
  • Support the database design and testing (UAT), using specialist clinical database applications
  • Support the development of the edit checks both manual and coded (e.g. using Java Script)
  • Support the development of protocols, plans, Standard Operating Procedures (SOP’s) and processes as required identifying areas for process improvement as appropriate
  • Upload study data to a variety of clinical and non-clinical databases and ensure ongoing timely data capture and data cleaning of all data sources
  • Monitor data quality and integrity, and ensure consistency in company data capture approach
  • Work closely with clients as a point of contact/trouble shooter for any data issues
  • Ensure study timelines are met and data quality is according to high industry standards
  • Oversee the issuing of queries and review query responses with the highest level of quality based upon the Data Validation Plan
  • Ensure all database modifications are communicated with the team and implemented effectively
  • Ensure adherence to GCP, regulatory guidelines, standard processes and SOPs
  • Generate data analysis status reports on clinical studies for the clinical study teams as required
  • Lock, transfer and archive databases
  • Manage client relationships and foster client engagement, maintaining good links to help generate new/repeat business
  • Proactively seek to develop own knowledge and experience in the evolving data collection tools applied within clinical trials
  • Deputise for the LDM as required
 Minimum Requirements – Education and Experience

 



  • A BSc/MSc (or equivalent) in life sciences, statistics or a related subject or industry equivalent experience
  • Proven data management expertise and a sound working knowledge of the data management process
  • An excellent understanding of Electronic Data Capture (EDC), ideally Viedoc and/or Data Management from clinical trials
  • Solid knowledge of clinical trial database technologies and processes
  • Minimum of 5 years’ experience working within the pharmaceutical/clinical trials industry
  • Good understanding of Good Clinical Practices and relevant regulatory guidelines
  • Ability to work collaboratively on multi-disciplinary project teams and proactively manage relationships with other
  • Significant experience in clinical data management across Phase 1 – 3 clinical trials
  • Able to compare and evaluate third party data management systems
  • Good project management, planning, risk, organisational and communication skills
  • Excellent written and verbal English
  • Excellent accuracy and attention to detail
  • Excellent computer literacy, including strong Microsoft Office skills (excel, word, powerpoint, project) and ideally JavaScript programming language
 This is an excellent opportunity to join a rapidly growing business that can offer on going personal development along with flexible working hours. Please call for more information or send your CV direct to lisa.k.a2tui34ek@nesgt.aptrack.co.uk

 

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