Full Time Permanent

Senior Clinical Data Manager

Posted 2 months ago
Application ends: October 29, 2021
Apply Now

Job Description

Introducing a brand new Senior Data Manager role with a partnered midsized CRO client of ours. We started our relationship with them 12 months ago working with Biometric & Clinical team within EU and since we formed a successful relationship with their team in the US.

They have a very bright future ahead looking to double in size in the next 2 years increasing both EU and US teams. As they are in the growing phase of the business it is a very exciting time to join them as you will be a crucial team member going forward.

Offering fully remote working across whole of US, Great Salary packages and Excellent Future Progression Plan.

Responsibilities:

  • Being the primary contact for both internal and external teams during in studies
  • Actively involved in reviewing study documents, case report forms, safety plans and statistical plans
  • Supporting database set up activities including design & validation.
  • Responsible for reviewing, maintaining all studies specific documents [data management plans, eCRF, validation plans etc] adhering to the study requirements.
  • Organising & completing database user acceptance testing
  • Sharing project specific & additional training to fellow team members
  • Reviewing & validating all clinical data, ensuring consistency & accuracy
  • Creating data cleaning plan & overseeing data base interim & final locks and updates post lock.
  • Presenting reports for internal and external vendors outlining any issues, feedback and progress of the study
  • Keeping projects on track with timeline in all aspects from budgets to resourcing  

Required

  • Degree in life science, healthcare and/or related field
  • 3+ years working within a CRO [preferred], Biotech or Pharma company
  • Basic knowledge of ICH-GCP(R2), GDPR/HIPPA and applicable (local) regulatory requirements
  • In-depth understanding of Leading Studies form start up to lock
  • Expert knowledge of using CDISC [CDASH, STDM model]
  • Ability to quickly and efficiently problem solve and have a technical eye for detail

Apply

AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.