Data Managemennt Lead - new job in Kingston Upon Hull, UK

Data Managemennt Lead
  • £65,000 - £85,000 per Annum
  • Permanent
  • Kingston Upon Hull, East Riding of Yorkshire, England, UK Kingston Upon Hull East Riding of Yorkshire UK HU3 2BN
Job Ref: J2166152
Sector: Engineering
Sub-sectors: Biotech/Life Sciences, Medical Devices
Date Added: 01 August 2022
Are you a data manager looking to progress your career? Data Management Lead role available at an established, global medical technology company.

Here at SRG, we partner with a global medical technology company, who design and manufacture a range of different devices from wound care to ENT to orthopaedics. They are looking for a Data Management Lead that will be responsible for leading the data management function across clinical trials from all business divisions. Working fully remotely.

As the Data Management Lead, you will be reporting Sr Director, and managing outsourced data management resource and processes from study development to database lock and regulatory submission support. Ensures clean and valid clinical study data for delivery to biostatistics. This position coordinates with data management programming, biostatistics, clinical systems team, study management and site management to define and implement data management standards and requirements. This position is responsible for vendor management and oversight. Some of your main responsibilities will include

  • Plan and manage data management aspects of global clinical studies through management and oversight of outsourced data management staff and liaison with internal study teams.
  • Responsible for outsourcing supplier contracts in line with the role.
  • Create and report data management updates to management on a regular basis; report on performance to plan.
  • Work alongside data management programming to ensure timely study start up and database availability.
  • Facilitate data cleaning and manage timeline to database lock; interact with study sites and S&N site management as needed; responsible for database lock.
  • Work alongside external data managers, with the ability to deal effectively with internal and external customers; organize and lead internal and external meetings with associated communications and materials.
  • Set strategic direction for eCase Report Form (CRF) standards and Data Management Quality Management System (QMS) and Standard Operating Procedures (SOPs). Maintain up to date eCRF library to ensure expedited database builds.
  • Review and approve applicable sections of regulatory submissions and contribute to regulatory submission strategy for clinical programs.

As the ideal candidate, you will be educated to degree level (or equivalent) in a data related field, life sciences or related area. You will have at least 8 years' experience in medical device industry, clinical setting or research field, pharma industry considered. You will have data management / project management skills, knowledge of industry standards and best practices in clinical such as US FDA, ISO, ICH, CDISC. You will be able to work strategically across cross functional teams and external vendors.

31/08/2022 13:56:20
GBP 65000.00 85000.00 Annum

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