Clinical Data Manager

About the role

The Clinical Data Manager (CDM) at EDETEK is responsible for managing project documentation, conducting clinical data management activities, and overseeing system implementations for EDETEK's eClinical platform. This role involves writing design specifications, facilitating testing, and ensuring the quality and integrity of clinical data.

Responsibilities

• Support internal clinical data management initiatives
• Complete traditional and assigned data management operations/activities
• Contribute to project success by conducting duties per CPM/LSCDM request
• Design case report forms (CRFs)
• Assist in the development and maintenance of systems used to support project infrastructure
• Work with Clinical Data Specialists (CDSs) to execute data management plans
• Work with clients/sponsors as necessary to deliver contracted clinical data management services and clinical data with high quality and integrity
• Code data per selected coding dictionaries
• Clean data
• Develop / execute testing strategies
• Absorb data transfers, loading, and integration
• Complete all required documentation per EDETEK and project requirements
• Perform use acceptance testing (UAT) on new software
• Classify clinical events per agreed-upon strategies/plans

Requirements

• Thorough understanding of Good Clinical Data Management services, including documentation
• Willingness to be involved in start-up or wrap-up of in-house and client-specific data management projects
• Understanding of relevant therapeutic indications, study hypotheses, and trial design
• Solid understanding of database design and structure
• Effective communication skills in English in person, by phone, and in writing
• Strong attention to detail and accuracy
• Excellent organizational skills
• Demonstrated ability to manage multiple projects
• Ability to work collaboratively, effectively, and productively in diverse organization structures
• Ability to work independently, take initiative, and complete tasks to deadlines
• Advanced computer skills and practical knowledge of MS Office and potentially project management software

Qualifications

• A Bachelor's degree or equivalent combination of Education/Training/Experience is required
• A degree in a scientific, medical, or technological discipline is preferred
• A minimum of 2 years of clinical trial or clinical data management experience or similar industry experience/training is required
• Prior trial responsibility for the entire data management life-cycle is desirable
• Prior working knowledge of EDC studies and SAS is required