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TITLE

 

Senior Clinical Data Manager

COMPANY

 

Impel NeuroPharma

LOCATION

 

Seattle, WA, US

Description

Reporting to the VP Clinical Development, the Senior Clinical Data Manager is responsible for managing the clinical trial data for multiple assigned projects.  The successful incumbent will act as liaison between Impel and CRO personnel to implement and maintain clinical databases, and ensure data integrity and conformance with current standards.  S/he will collaborate on project or software-related training, and coordinate internal planning and activities such as medical coding, electronic data transfer, and all other aspects of data cleaning.  This individual will provide project oversight of daily, weekly and monthly data management tasks and CRO deliverables to ensure assigned projects and deliverables are on track, delegating tasks (as needed) to other team members.  Additionally, s/he will serve as a technical resource to colleagues, troubleshooting technical problems and ultimately managing more complex projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

  • Act as Lead Data Manager on Impel clinical studies
  • Design, or oversee the CRO’s design of, an Electronic Data Capture (EDC)/Data Management system, including the design/review of Case Report Forms and system edit checks
  • Develop User Acceptance Testing (UAT) Plans and coordinate with team members to perform UAT
  • Develop and/or review Data Management Plans (DMPs), outlining and confirming all data management responsibilities
  • Oversee the completion of data entry, including tracking CRF data entry, query generation/resolution
  • Work with the study team, e.g., Clinical Development, Biostatistics, Regulatory, and/or CRO, to complete comprehensive, timely data review and resolve data issues
  • May develop ad hoc listings, patient profiles, and/or additional data checks using software such as SAS, J-review, or other software
  • May perform coding of medical events/medications
  • Conduct/oversee database lock activities: ensure all database lock activities are performed prior to final database lock, oversee generation of CRF archival files, ensure project documentation is provided to Impel and filed, if applicable
  • Review and/or conduct and document project-specific training for all team members prior to project start and throughout the course of the project, as needed
  • Train or coordinate training for end users on the applicable EDC/ Data Management system, maintaining current system access and ensuring all training records are up to date. May perform study specific CRF training at Investigator Meetings
  • Coordinate and delegate work performed by study data managers, as needed; assist in mentoring of more junior data managers
  • Lead writing/reviewing/updating Data Management related Standard Operating Procedures (SOPs) and oversee training of appropriate staff in their interpretation and use
  • May prepare and present data management topics to Clinical Development and other Impel departments
  • Lead assessment and selection of data management systems, if applicable

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED:

  • Bachelor’s degree in a related field of study preferred
  • 10+ years leading DBM study activities or equivalent combination of education and experience
  • Certified Clinical Data Manager (CCDM) is an asset
  • SAS programming is an asset
  • Minimum 5 years’ experience with Medidata Rave. Experience with other platforms (e.g. Oracle Inform) beneficial
  • Experience working within a Sponsor environment, overseeing vendor and contract management
  • Experience writing, reviewing and editing EDC specifications to assure alignment with clinical protocols and SAPs
  • Knowledge of Good Clinical Practice (GCP) and FDA regulations is expected
  • Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook
  • Strong attention to detail and ability to effectively prioritize tasks and assignments to meet deadlines
  • Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, executive management, external vendors, KOLs, and customers
  • Ability to exercise judgment and determine appropriate action
  • Ability to work independently and unsupervised and manage deadlines

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Must have demonstrated ability to multitask in high pressure, changing conditions.

WORKING CONDITIONS

This is a fast-paced environment with moderate noise level.  Limited travel, mostly national, may be required.

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