Clinical Data Management Manager

Clinical Data Management Manager

Amgen

Cambridge or Uxbridge, United Kingdom

What you will do

In this vital role you will responsible for ensuring clinical projects are executed according to set timelines with quality and consistency. The successful candidate may be responsible for one or multiple products depending on the complexity.

You will be responsible to ensure that Data Management (DM) procedures and processes are adhered to by vendor staff through oversight of quality, cycle times, metrics and use the Issue CAPA process. Key responsibilities include, but not limited to:

  • Project level coordination of and day to day oversight of DM tasks including: Review all DM documents within a project area to ensure a consistent approach and review of project timelines and metrics to ensure databases are delivered to set timelines, and approve database locks and unlocks;
  • Ensure that quality control checks are occurring such that quality databases are delivered;
  • Develop and co-ordinate project level training for data management staff;
  • Review and approve study specific training and lead vendor results and relationship at the project level;
  • Communication of project level issues including processes, timelines, resourcing, performance, etc.;
  • Review of all study level non-DM documents for awareness and project level consistency;
  • Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study/vendor level;
  • Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

  • Degree educated in life science, computer science, business administration or related discipline;
  • Broad and proven experience in life sciences or a medically related field including experience in biopharmaceutical clinical research experience;
  • Extensive Data Management experience in a global organization;
  • Previous experience at or oversight of outside clinical research vendors (CRO’s, central Labs, vendors, etc.);
  • Knowledge of Good Clinical Practice, Drug development and clinical trials processes, clinical trial databases and applications, Quality Management, Regulatory filings and inspections, Risks analysis, Process improvement methodologies is essential.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

United Kingdom      Clinical Data Management      Clinical Research      Data, Programming and Statistics      Amgen     

© EuroJobsites 2024