Job Description
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) discipline
- Facilitate and assist with training of junior Clinical Data Managers
- Assist with process improvement initiatives, as needed
- Assist with creating and improving tools for metric reporting
- Able 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 guidance
- Ability to be a Lead CDM at a Sponsor program level and maintain oversight of all studies
- Oversight of all clinical data management activities for assigned studies in accordance with Standard Operating
- Procedures (SOPs) and Procedure Guides (PGs)
- Primary Sponsor contact for all data management processes on study
- Ability to support and present at sponsor or external entity related meetings and audits
- Build and maintain a positive and collaborative relationship with internal and external project teams
- Provide high level customer service to all internal and external teams
- Responsible for attendance at all team meetings
- Responsible for effective verbal and written communication of study progress with internal and external
- project team members
- Responsible for CRFs from the creation of the blank CRF through delivery of final CRF to Sponsor
- Ensure clinical database is set up per specifications
- Perform testing of clinical database, as required
- Create, maintain, and archive Data Management Plan, CRF Completion Guidelines, Data Validation Plan, and other study documents required per SOP and study needs, as applicable
- Maintain ongoing and timely clinical data cleaning for all assigned studies
- Manage and deliver on time database locks with high quality
- Generate, resolve, and track queries to address discrepant data identified during review
- Proactively ensure on-time delivery of all DM study deliverables per agreed upon study timelines
- Manage data management metrics for all assigned studies
- Regularly assess project activities for any issues or risk and escalate accordingly to management
- Ability to work independently and support other Clinical Data Managers as needed
- Up-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 required
- 1 - 3 years industry experience required
- Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21
- CFR Part11 required
- Knowledge of data management or analytics required
- 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
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.
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.
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