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 FunctionsOversight of all clinical data management activities for assigned studies in accordance with SOP’s and Procedure GuidesPrimary Sponsor contact for data management processes on studyResponsible for regular communication of study progress with internal and external project teamOversee CRFs from the creation of the blank CRF through delivery of final CRF to sponsorEnsure database is set up per specifications and perform User Acceptance Testing (UAT) of clinical databaseCoordinate creation of Data Management Plan, CRF Completion Guidelines, Data Validation Plan, and other study documents required per SOP and study needsManage clinical data cleaning and delivery activities up to and including database lockReview clincal data to ensure accuracy, quality, and integrity of dataGenerate, resolve, and track queries to address discrepant data identified during reviewPerform third party data reconciliationsCoordinate data transfers (clinical data and vendor related data) with assigned Data Programmer and Sponsor contactProactively ensure on-time delivery of study deliverables through monitoring of study timeline commitmentsManage and appropriately handle/archive all CDM study materials (internally and sponsor specific)Proactively assess project activities and identify issues and/or riskProvide high level customer service to all internal and external clientsPerform Quality Control reviews on studies, as neededKnowledge/Skills/Education/LicensesHigh School Diploma or GED, College degree strongly preferred1-2 years industry experience preferredKnowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferredKnowledge of SAS preferredAbility to manage multiple projects/priorities requiredHigh attention to detail requiredExcellent oral and written communication skills requiredExcellent organizational skills requiredProficiency in MS office applications requiredCelerion 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.