Ecocareers ยท 3 months ago
Clinical Data Manager
Phoenix, AZ
Full-time
Onsite
Senior Level
7+ years expEcocareers is a confidential company seeking a Clinical Data Manager to oversee data management deliverables for clinical studies. The role involves establishing data sharing procedures, managing resources, ensuring database security, and compliance with regulations.
Staffing & Recruiting
Responsibilities
Take necessary actions to ensure data management deliverables are met
Establish rules and procedures for secure and responsible data sharing with executives
Manage data management resourcing for all clinical studies, as required
Prepare documents and ensure tools are arranged to allow for data capture and data cleaning
Ensure delivery of a clean and secure database
Instruct, communicate, coach and mentor others on data management procedures
Ensure compliance with EMEA, FDA, and ICH GCP regulations and policies
Ensure compliance with appropriate Sponsor SOPs
Qualification
Required
BS/BA degree with preference in a biological, analytical/data, health related, or computer science field
7-10 years related experience in a pharmaceutical or CRO setting
5 years' experience in Data Management
A knowledge of EDC solutions (Oracle Clinical, Medidata RAVE, Inform, etc.)
Experience working on studies both insourced or outsourced to a CRO
Current computer literacy in appropriate software (i.e. Current with recent versions of Microsoft Office software suite)
Strong management and motivation skills
The ability to manage study teams and perform issue escalation to meet database cleaning and lock timelines
Extensive and comprehensive knowledge of international ICH GCP guidelines
Excellent interpersonal, written and oral communication skills
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase