Clinical Data Associate Manager

lausanneFixeChimie, Pharma, Biotechnologie2019-06-21Master / Université
We are Recruiting an experience clinical data manager to strenghten the team.

Clinical Data Associate Manager

Your Responsibilities

  • Clinical Data Reports; Develop scripts to produce study-specific clinical data status reports as required
  • Review clinical data on an ongoing basis to ensure compliance of data Integrity and quality control procedures
  • Liaise directly with Clinical Research Associate (CRA) to ensure data discrepancies are addressed in a timely manner
  • Point of contact for project manager, statistician and/or sites, regarding clinical data, data reporting needs and data analysis
  • Contribute to Data Management (DM) documents such as Data Management Plan (DMP), Data Validation Plan, Data Review Plan, annotated CRF, CRF Completion Guidelines to ensure standardization
  • Responsible for database build activities such as; input in database selection and coordination of CRF design, edit check development and user acceptance testing, for all versions.
  • Provides effective user support during data base implementation
  • Ability to support design, develop, implement, maintenance and support clinical databases for clinical studies/registries TBC
  • Work with database programmer to develop reconciliation reports and performs data reconciliation
  • Responsible for ensuring reporting requirements are met and are standardized across the clinical program
  • Contribute during database vendor qualification and audit
  • Perform strategic research, from various data sources and scientific literature, and synthesizes, analyzes, edits, and filters information appropriately
  • Prepare presentations for colleagues and present clinical data status reports for both internal and external stakeholders
  • Work independently within projects and actively seeks to develop the role further to support Clinical Affairs projects
  • Assist in building departmental initiatives
  • Responsible for support of multiple studies simultaneously in a dynamic environment

Your Profile

  • Bachelor's degree with minimum 8 years' experience in the clinical research field including 3+ years of relevant work experience in Data management.
  • Experience working with medical data in a research environment
  • Strong knowledge and adherence to Good Clinical Practice (GCP) and other clinical affairs regulatory practices and laws and of clinical trial process, CRF design, Clinical database applications such as EDC and CTMS.
  • Excellent understanding of data administration and management functions (collection, analysis, data review process, etc.)
  • Proficient in the use of data management software and MS Office (Excel, PowerPoint, Word, etc.) and SAS software.
  • Proven ability to working with multiple teams on multiple projects simultaneously
  • Demonstrated flexibility when prioritizing work and delivering on goals
  • Excellent analytical and problem-solving skills
  • Excellent written, verbal communication and presentation skills
  • Ability and willingness to travel 30% of the time, primarily via plane or train
  • Ability to work independently and in a team-oriented environment.
  • English fluent

Votre contact

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