Clinical Development Centre - Project Manager at Novo Nordisk

The position

As CDC Project Manager, you will be responsible for Project planning and management for assigned trial/research projects for the CDC, and ensuring deliverables are met as per project timelines, within budget and complying with Protocol, regulatory requirements, GCP (Good Clinical Practice) and NN SOPs (Standard Operating Procedures). You will be leading several project teams, setting project-specific strategies and providing direction to ensure successful project delivery. Furthermore, you will do proactive risk identifications and mitigation plans at CDC level while being well-versed with Clinical reporting tools and you will co-monitor with based on project risks.

Your main accountabilities will be:

• Responsible for driving the clinical projects, which includes planning, conducting and coordinating of project activities, providing operational and therapeutic expertise to the project, achieve deliverables within agreed timelines and in accordance with scientific, quality and regulatory requirements (70%)
• To ensure effective communication of all trial/project-related issues between HQ, CDC and region and other Internal/external stakeholders (20%)
• Responsible for representing CDC countries in relevant study meetings: Trial Group Meetings, Monitor meetings, Investigator meetings, and Study Result meetings (10%)
• Overall responsible for project planning, management and execution of assigned clinical trials in the CDC in accordance with applicable regulatory requirements, NN Protocols and SOP’s.
• Ensure preparation and submission support of local Clinical Trial Applications to Health Authorities as soon as possible in order to obtain all necessary regulatory approvals within a defined timeline. Ownership of trial-related meetings with the CDC trial team.

Qualifications

• You have a minimum Bachelor's degree level, preferably in life science, pharmacy or nursing qualification with a minimum of 3 years of working experience within trial management and monitoring clinical trials in accordance with ICH GCP methodology in a commercial company.

You will also need to have:

• Knowledge of clinical trial methodology
• Knowledge of the clinical trials environment – ICH GCP, NN SOPs
• Good working knowledge of electronic clinical trials systems – CTMS, EDC, IWRS, electronic TMF
• Computer literacy and proficiency in MS Office