Celerion Lincoln , NE 68501
Posted 3 days ago
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
The Clinical Data Manager is responsible for the integrity of the data entered into a Celerion system and/or Sponsor provided system. Ensures database is complete, accurate and consistent and meets quality standards required by Sponsors and regulatory bodies. Collaborates and participates in multidisciplinary teams involved in setting up, conducting and reporting clinical trials. Responsible for Sponsor contact, project communication and timeline management for all data management functions. Manages, organizes, and processes clinical data using a range of computer applications and database systems to facilitate collection and cleaning of subject data.
Essential Functions
Oversight of all clinical data management activities for assigned studies in accordance with SOP's and Procedure Guides
Primary Sponsor contact for data management processes on study
Responsible for regular communication of study progress with internal and external project team
Oversee CRFs from the creation of the blank CRF through delivery of final CRF to sponsor
Ensure database is set up per specifications and perform User Acceptance Testing (UAT) of clinical database
Coordinate creation of Data Management Plan, CRF Completion Guidelines, Data Validation Plan, and other study documents required per SOP and study needs
Manage clinical data cleaning and delivery activities up to and including database lock
Review clincal data to ensure accuracy, quality, and integrity of data
Generate, resolve, and track queries to address discrepant data identified during review
Perform third party data reconciliations
Coordinate data transfers (clinical data and vendor related data) with assigned Data Programmer and Sponsor contact
Proactively ensure on-time delivery of study deliverables through monitoring of study timeline commitments
Manage and appropriately handle/archive all CDM study materials (internally and sponsor specific)
Proactively assess project activities and identify issues and/or risk
Provide high level customer service to all internal and external clients
Perform Quality Control reviews on studies, as needed
Knowledge/Skills/Education/Licenses
High School Diploma or GED, College degree strongly preferred
1-2 years industry experience preferred
Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred
Knowledge of SAS preferred
Ability to manage multiple projects/priorities required
High attention to detail required
Excellent oral and written communication skills required
Excellent organizational skills required
Proficiency in MS office applications required
Celerion Values: Integrity Trust Teamwork Respect
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
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