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location: Deerfield, Illinois
job type: Contract
salary: $50.00 - 54.07 per hour
work hours: 9 to 5
•The position is responsible for supporting clinical data management (CDM) operational activities in one or more therapeutic areas.
•Support the creation, execution and maintenance of Data Management Plans (DMPs) in support of clinical study deliverables.
•Lead or contribute to the design, creation and lifecycle management of data collection, validation and reporting specifications and usage guidelines.
•Employ standardized electronic and adhoc reporting tools and collaborate with the SAS programming team to review clinical data for consistency with the protocol requirements and good clinical practices.
•Partner with Clinical Operations personnel to manage the query lifecycle.
•Represent Clinical Data Management in study team meetings and facilitate cross-functional activities (e.g. Clinical Data Listing Reviews, SAE Reconciliation)
•Partner and openly communicate with the study team to proactively address operational issues and clinical data questions.
•Partner with External Service Providers (ESPs) (e.g. CROs, EDC Vendors, Central Labs) in order to support business goals and further the mission of CDM.
•Minimum: BA/BS and 4+ years of experience or equivalent.
•Preferred: Masters degree in a related field or MBA with 4+ years of CDM experience in the Pharmaceutical, Device or Biotech industries (Sponsor, CRO or combination) in roles of increasing responsibility.
•3+ years of project leadership and global and/or cross-functional collaboration experience.
•Microsoft Office Suite: Excel, Word, Outlook, PowerPoint, & SharePoint; MetaData: RAVE
•Excellent analytical, problem-solving, organizational, time-management, interpersonal and communication skills
•Knowledge of all aspects of the clinical trials process from pre-clinical to post-marketing phases
•Ability to interpret and apply regulatory requirements
•Knowledgeable concerning aspects of qualification and compliance assessments
•Demonstrated ability to effectively partner with ESPs
•Technical understanding of clinical research technologies and data validation methodologies
•Knowledge of systems integration and data interchange standards
•Proficient in the use of one or more of the leading Clinical Database Management Systems
•Current with industry developments, trends and opportunities
skills: MS-WORD, MS-EXCEL, MS-Powerpoint, Clinical Data Management
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.