Clinical Data Manager

Job Description

As a Clinical Data Manager, you will oversee the collection, management, and analysis of data from clinical trials. Your role involves ensuring the accuracy and integrity of data while collaborating with cross-functional teams to develop effective data management strategies.

Responsibilities

• Lead the development of data management documentation and standards.
• Implement and oversee electronic data capture (EDC) systems.
• Conduct training sessions for staff on data management processes.
• Collaborate with statisticians and researchers to determine data needs.
• Manage the data querying process to ensure data completeness.
• Contribute to risk assessment and mitigation strategies in data management.
• Utilise statistical software for data analysis where necessary.
• Review and validate study-related documents for compliance.
• Engage with regulatory bodies to ensure adherence to guidelines.
• Foster an environment of continuous improvement within the data management team.

Requirements

Education

• Master's degree in a relevant field is a plus
• Relevant certifications or training in clinical data management

Experience

• 5+ years of experience in clinical data management, preferably within pharmaceuticals

Technical Skills

• Clinical Trial Management Systems (CTMS)
• Data Validation

Soft Skills

• Leadership
• Stakeholder Management

Certifications

• ISO 9001 Certification
• Clinical Trial Administrator Training

Languages

• English: Fluent

Advantageous

• Understanding of data coding dictionaries: Experience with dictionaries such as MedDRA and WHODrug.
• Proficiency in Microsoft Excel and data management tools: Strong skills in using Excel for data analysis and management.

Benefits

• Attractive salary package and annual performance bonuses.
• Health insurance coverage and wellness programmes.
• Options for remote work and flexible hours.
• Training and career advancement opportunities.
• An inclusive and supportive workplace culture.

Company Culture

• Continuous Improvement: We are dedicated to continuous improvement and professional development for all team members.
• Respect and Integrity: Our values include respect for individuals and integrity in our processes.
• Work-Life Balance: We prioritize work-life balance, allowing flexibility for employees to manage their personal and professional lives.