Job Description

• Participate in clinical meetings with Sponsor and KPS personnel as required.
• 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.

Requirements:

• BS/BA or master's 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.
• 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.
• 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.

Job Tags

Similar Jobs