Clinical Data Manager - UK/Hybrid

Odin Vision is a multi-award-winning company that provides state-of-the-art AI-enabled software applications for endoscopic procedures. These applications aid clinicians in the detection and diagnosis of disease, supporting higher quality care, improved patient outcomes, and better value for healthcare payers.

We are looking for a full-time Clinical Data Manager to support the clinical assessment of Odin Vision's Medical Devices. You will lead the Clinical Data Management activities within the Medical Affairs team. You will collaborate with the clinical operations team and clinical experts to ensure data integrity and regulatory compliance during clinical trials. This position requires a proactive individual with excellent organisation and communication skills.

This full-time hybrid role requires national and international travel and attendance at live endoscopy procedures.

Salary range - £35-50K

The Team:

The Medical Affairs Department at Odin Vision is a newly established and rapidly growing team dedicated to generating robust clinical evidence required to develop and assess our innovative devices.

As a new team, we are dynamic and fast-paced, with professional growth and leadership opportunities. You will have the chance to shape the direction and strategies of our projects from the ground up.

We seek a highly motivated individual who is adaptable and excited about the challenge of building something new.

Key Responsibilities:

• Project management: Lead all data management processes required for clinical evaluations. Verify that data collection and management are conducted according to good clinical practice (GCP), standard operating procedures (SOPs) and other compliance standards.
• Electronic Data Capture: Design, develop, and maintain study case report forms (CRFs) using commercial EDC software (Greenlight Guru).
• Process development: Develop new systems and processes for efficient and accurate data collection and verification. Communicate data management needs to software development team.
• Stakeholder communication: Collaborate with clinical consultants and key opinion leaders in developing study CRFs. Generate and present clinical trial progress reports. 
• Data monitoring: Monitor clinical trial data for accuracy and integrity, raise and resolve queries with research staff, and perform monitoring visits.
• Documentation: Develop and maintain data management SOPs and other documentation and record management systems, including the Trial Master File.
• Site training: Develop and perform EDC training with research staff.
  
  

Qualifications

• Undergraduate degree, or equivalent, in data management, or a biomedical, scientific or statistical field.

Required experience:

• Experience of data management in clinical or non-clinical research.
• Experience with data monitoring and validation.
• Awareness of data protection laws.
• Project management/leadership

Desirable for the role:

• Experience with developing electronic case report forms (eCRFs).
• Experience of data management in clinical trials or clinical research in an academic environment.
• In depth working knowledge of the current EU Clinical Trials Directive, UK Clinical Trials regulations, Principles of GCP, Data Protection Act, GDPR and Research Governance Framework legislation.
• Proven clinical data management experience gained in multi-centre randomised Medical Device trials.

At Odin Vision we believe that diversity is an important contributor to our success and long-term company goals. Diversity in our teams can contribute to innovations and creativity and increase our ability to cope with change. Odin Vision is committed to encouraging equality, diversity and inclusion among our workforce, and eliminating unlawful discrimination. The aim is for our workforce to be truly representative of all sections of society and our customers, and for each employee to feel respected and able to give their best.

Find out more:

Follow Odin Vision on LinkedIn

https://www.linkedin.com/company/14067058/

https://odin-vision.com/