Senior Data Manager

Company Description

PSI is a leading Contract Research Organization with 30 years experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

The Senior Data Manager will be responsible for oversight of all data management activities in large, complex studies.

Communication

• 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

Data Management

• 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

• Training junior members of the team
• Project-specific training of investigators and clinical team in CRF completion

Qualifications

• 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

Additional Information

Advance your career in clinical research and develop new skillsets whilst growing with the organization.