Remote - Clinical Data Manager

A highly reputable pharmaceutical corporation is currently hiring a qualified Remote Clinical Data Manager.

Job Description

• Quality Assurance: Experienced Data Management team member who has demonstrated experience in ensuring compliance with regulatory standards (e.g., FDA, ICH GCP) and company SOPs in data management activities.
• Assist in the preparation of data for regulatory submissions and audits.
• Provide data-related support during clinical trial activities and interactions with regulatory agencies.
• Documentation: Maintain detailed documentation of data management activities and quality control measures.
• Team Collaboration: Work closely with clinical research teams, biostatisticians, and other stakeholders to support submission preparations.

Qualifications:

• Bachelor's Degree in a relevant field (e.g., Life Sciences, Data Management, Biostatistics)
• 7 plus years experience in Data Management, particularly with submission preparation experience.
• Proven experience in clinical data management, preferably in a pharmaceutical, biotechnology, or clinical research setting.
• Knowledge of regulatory requirements and industry standards for clinical data management.
• Strong attention to detail and organizational skills.
• Excellent communication and interpersonal skills.