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Manager, Clinical Data Management

Position Summary:              

Responsible for managing and/or executing the design, documentation, testing and implementation of data collection systems and processes through the life cycle of a clinical trial.  Develop study CDM priorities and ensure that all data management procedures are executed with high quality and within the agreed upon timelines.  Drive the delivery of study data quality and integrity from the data source through data submission and archiving.
 

Essential Functions:

  • Provide oversight and guidance to CROs for outsourced Clinical Data Management activities.
  • Execute or oversee data management activities/deliverables including protocol review, eCRF development, database set-up, User Acceptance Testing, data validation processes (including data listing review), external data transfers and reconciliation, SAE reconciliation, coding, and other tasks.
  • Author or review/approve CDM documentation and plans such as DMP, eCRF completion guidelines, data review plans, data transfer plans, SAE reconciliation plans, and medical coding plans.
  • Review metrics to evaluate performance and identify trends in data entry, query resolution, and other data issues across individual sites and the entire study. 
  • Lead cross-functional data review activities of EDC and external data sources to identify quality issues and data trends; work with the team to generate and review queries.
  • Represent CDM on study teams to provide updates on timelines, metrics and data issues.
  • Coordinate activities by other Achaogen functions, CROs and/or vendors to achieve DM deliverables. 
  • Participate in presentations and trainings to internal cross functional team members and site/CRO/vendor personnel.
  • Participate in the development and implementation of department standards, processes, documents, and other data management departmental activities.
  • Contribute towards technology/process improvements and assure consistency of data collection and data standards across multiple projects and systems.

 

Preferred Experience and Education:

  • BA/BS or higher degree is required.
  • 5+ years of experience as a lead clinical data manager with experience working on global phase III studies in the pharmaceutical/biotechnology industry is required. Experience in infectious disease studies is preferred.
  • Data Management expertise using EDC systems is required and Medidata Rave experience is preferred.
  • Experience managing CDM CROs is required.
  • Understand regulatory guidelines such as ICH, 21 CFR Part 11, GCP, and GCDMP is required.
  • Knowledge of MedDRA and WHODrug data dictionaries.
  • Relevant involvement in support of regulatory filings and regulatory inspections is preferred.
  • Strong understanding of clinical data and hands-on experience with all steps in the clinical trial process from study start-up through database lock.
     

Preferred Additional Skills:

  • Excellent organizational and communication skills (verbal and written) are essential.
  • Strong interpersonal and relationship skills that allow you to work well cross-functionally, within Achaogen as well as with external vendors and CRO partners.
  • Ability to work as part of a team, in a highly dynamic environment, and managing multiple priorities in a fast-paced environment.
  • Experience with data visualization and review software tools (e.g. Spotfire, JReview, etc.).
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Current US work authorization required.
  • Ability to travel domestically as needed.
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