Clinical Data Manager

Responsibilities

• Oversee and manage the Sponsor’s clinical programs with regard to data management activities for clinical trials as directed by the Sponsor or designee.
• Manage, when required, any third‑party vendors and data feeds from those suppliers.
• Participate in clinical meetings with the 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.

Qualifications

• BS/BA degree, preferably in a biological, analytical/data, health‑related, or computer science field.
• 7–10 years of related experience in a pharmaceutical or CRO setting.
• 5 years of experience in Data Management.
• Knowledge of EDC solutions (e.g., Oracle Clinical, Medidata RAVE, Inform, etc.).
• Experience working on studies both insourced and outsourced to a CRO.
• Current computer literacy with recent versions of the 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.