Study Site Monitor | Clinical Operations

Location

Home-based (Germany)

Description

Why Exom Group? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Evolve in a global company that is always investigating options for working smarter and more efficiently. You’ll be supported with comprehensive resources based on today’s emerging technologies, data, science, and knowledge – instead of practices from the past. Teaming with some of the most talented professionals in the industry, you’ll gain exposure and work in a dynamic environment to over-deliver and outperform.

At this moment, we are looking for a  Study Site  Monitor to join Exom Group with a relevant degree, monitoring experience, and strong English. But most of all, we are looking for a sparkling person, who is enthusiastic about this job.

Responsibilities:

• Conduct site selection, initiation, monitoring, close-out visits for the designated sites
• Perform all the assigned tasks according to the project-specific monitoring manual and ICH-GCP
• Maintain regular communication with the clinical sites, reports in writing all site visits and other contacts, informing Project Management about study progress and/or any problems with the sites
• Develop and maintain a full and detailed understanding of the protocol, study procedures, and any other study-specific requirements for designated projects
• Ensure that the investigators and other study staff are aware of and comply with the study protocol, procedures, and SOPs and with GCP and other regulatory requirements
• But most of all, we are looking for a sparkling person, who is enthusiastic about this job.
• You can work from home and there is full flexibility in terms of working hours.

Requirements:

• A minimum of a Bachelor’s Degree in Life Sciences.
• Experience of working in a pharmaceutical or CRO environment.
• Previous monitoring activities experience in an international environment, with various therapeutic areas.
• Fluency in both English and Germany.
• Proven knowledge and experience working in an FDA/EMA regulated GxP environment, in a biotechnology/pharmaceutical/CRO environment.
• Ability to manage complexity and manage a diverse team – strongly influencing, negotiating, and leading at different levels in a metrics organization.
• Excellent management skills, written and oral communication and interpersonal relationship skills, organizational/prioritization skills, and multitasking.
• Ideally, experience in the use e-TMF, CTMS and RBM.