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.
Responsible for the integrity of the data reported into the Celerion clinical database 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 and organizes, clinical data processes using a range of computer applications and database systems to facilitate collection and cleaning of subject data.
Essential Functions Demonstrate subject matter expertise in one or more areas of Clinical Data Management (CDM) disciplineFacilitate and assist with training of junior Clinical Data ManagersAssist with process improvement initiatives, as neededAssist with creating and improving tools for metric reportingAble to lead more complex studies including, but not limited to Tobacco, TQT, Radio labeled, ophthalmology, oncology, respiratory, BE, etc., as well as Phase I - IV study programs with minimal guidanceAbility to be a Lead CDM at a Sponsor program level and maintain oversight of all studiesOversight of all clinical data management activities for assigned studies in accordance with Standard OperatingProcedures (SOPs) and Procedure Guides (PGs)Primary Sponsor contact for all data management processes on studyAbility to support and present at sponsor or external entity related meetings and auditsBuild and maintain a positive and collaborative relationship with internal and external project teamsProvide high level customer service to all internal and external teamsResponsible for attendance at all team meetingsResponsible for effective verbal and written communication of study progress with internal and externalproject team membersResponsible for CRFs from the creation of the blank CRF through delivery of final CRF to SponsorEnsure clinical database is set up per specificationsPerform testing of clinical database, as requiredCreate, maintain, and archive Data Management Plan, CRF Completion Guidelines, Data Validation Plan, and other study documents required per SOP and study needs, as applicableMaintain ongoing and timely clinical data cleaning for all assigned studiesManage and deliver on time database locks with high qualityGenerate, resolve, and track queries to address discrepant data identified during reviewProactively ensure on-time delivery of all DM study deliverables per agreed upon study timelinesManage data management metrics for all assigned studiesRegularly assess project activities for any issues or risk and escalate accordingly to managementAbility to work independently and support other Clinical Data Managers as neededUp-to-date adherence for all required training Knowledge/Skills/Education/Licenses Bachelor degree in Business, Science or related field or a combination of education and relevant experience in lieu required1 - 3 years industry experience requiredKnowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21CFR Part11 requiredKnowledge of data management or analytics requiredAbility to manage multiple projects/priorities requiredHigh attention to detail requiredExcellent oral and written communication skills requiredExcellent organizational skills requiredProficiency in MS office applications required Working Conditions/Equipment/Safety Employees are expected to comply with Celerion policies and procedures, and to conduct themselves in a professional manner at all times including appropriate attendance standards. Employees are expected to comply with appropriate policies and procedures as it relates to handling Celerion confidential and proprietary information. Requires prolonged sitting, viewing computer screens and long periods of oral communication by telephone. Ability to adjust work hours to meet workload priorities. Minimal travel as needed. Conformance Statement Employees are expected to comply with Celerion policies and procedures, and to conduct themselves in a professional manner at all times. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required of individuals so classified. This job description is subject to change at any time. Additional Information Celerion Values: Integrity Trust Teamwork Respect
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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.
