Clinical Data Manager - Celerion
Lincoln, NE 68502
About the Job
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.
PI250144558
Source : Celerion
