PSI CRO AG

Senior Data Manager

PSI CRO AG

full-time

Posted on:

Location Type: Remote

Location: United Kingdom

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Job Level

Senior

Tech Stack

Oracle

About the role

  • The Senior Data Manager will be responsible for oversight of all data management activities in large, complex studies
  • Provide general oversight on all Data Management activities on large complex global studies
  • Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting
  • Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables
  • Primary responsibility for clinical data management activities within clinical projects, including, but not limited to: Reviews and approvals, escalation point and troubleshooting
  • Involved in audits and inspections
  • Supporting with SOP development and process improvements
  • Provide input into Proposals, Budgets and Bid Defense meetings
  • Clinical database lock Coordination and supervision of processing, dispatch and archiving of CRFs/queries
  • Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol
  • Development of CRF completion guidelines
  • Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required)
  • Electronic data transfer (import/export) specifications review and approval
  • Quality Control Database QC checks performance and documentation
  • Shared responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data Management
  • Shared responsibility for follow-up on and resolution of audit findings pertaining to Data Management
  • Training junior members of the team
  • Project-specific training of investigators and clinical team in CRF completion

Requirements

  • College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities
  • Significant experience of full scope of data management responsibilities in international EDC studies
  • Experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)
  • Organizational and managerial skills
Benefits
  • Advance your career in clinical research and develop new skillsets
  • Flexible working hours
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
data managementclinical data managementEDC developmentdata collectiondata cleaningdatabase lockCRF designcoding medical dataquality controlaudit preparation
Soft Skills
communicationcoordinationtroubleshootingorganizational skillsmanagerial skillstrainingprocess improvementoversightproblem-solvingteam leadership