Clinical Data Managers – All Levels – Homebased US East Coast

Posted 3 weeks ago
North Carolina
Application ends: April 30, 2021
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Job Description

We have partnered with a CRO client who are currently looking to extend their talented team in the US. They are looking for Data Managers of all levels to be working across all different therapy areas and phases. The positions are fully homebased, offering a great salary package and progression plan. 

Duties 

  • Be primary contact for DM queries across all internal teams & external vendors
  • Reviewing of study documents (e.g. protocol, (electronic) case report forms (eCRFs), safety plans/manuals and statistical analysis plan)
  • Provide support on clinical study database set-up, including eCRF design and database validation requirements
  • Develop, review and maintain project-specific DM documents 
  • Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks
  • Create training materials for EDC users and provide project-specific training
  • Review & validate clinical data to ensure accuracy, integrity and completeness
  • Create Data Cleaning Plan in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)
  • Provide project reports 
  • Perform and/or coordinate various data reconciliation activities including (but not limited to) SAE & PK
  • Perform Medical Dictionary for Regulatory Activities (MedDRA) and/or World Health Organization Drug Dictionary (WHO-DD) medical coding procedures
  • Adhere to project timelines 
  • Manage the database setup, lock activities according to procedure 
  • Organize and distribute study data to facilitate statistical analysis and reporting
  • Assist in planning & providing documentation for audits   
  • To be able to lead studies [if senior role], work as well as a team, supporting and guiding each other 

Qualifications

  • B.S. degree in life science, healthcare and/or related field
  • 2+ years experience within a CRO, Pharma or Biotech industry 
  • Basic knowledge of ICH-GCP(R2), GDPR/HIPPA and applicable (local) regulatory requirements
  • Experience in CDISC conventions, i.e., CDASH, SDTM model and hands on experience implementing these models
  • Eye for detail, strong technical, analytical and problem-solving skills

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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.