Clinical Trial Manager II (Biopharmaceutical, Hybrid, Denmark)

Job summary

This role involves overseeing clinical trial management activities, ensuring compliance with protocols and regulations, and maintaining data integrity throughout the trial process. The position requires collaboration with various teams to meet study milestones and deliverables while focusing on patient safety and effective site management.

Qualifications

• Proven experience in clinical trial management, particularly in a start-up environment.
• Strong understanding of GCP, regulatory requirements, and clinical monitoring processes.
• Ability to identify and mitigate risks related to clinical trial deliverables.

Responsibilities

• Manage site interactions from activation to closeout, including patient recruitment and investigator payments.
• Review study scope, budget, and protocol content to ensure compliance with contractual obligations.
• Utilize operational data to identify risks and escalate issues to project management as necessary.
• Participate in key meetings and serve as a communication point for site staff.
• Collaborate with functional leaders to coordinate study milestones and deliverables.
• Develop and maintain clinical study tools and templates, ensuring proper system setup and user acceptance testing.
• Provide training to study teams on protocol specifics and operational procedures.
• Oversee resource allocation and quality of clinical monitoring deliverables.

Skills

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal abilities.
• Proficiency in clinical trial management systems and related tools.

Education

• Relevant degree in life sciences or a related field.

Tools

• Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), dashboards, and other clinical trial systems.