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CRA Manager Denmark

Job Description

Clinical Research Associate (CRA) Manager, Denmark

50! This is the number of clinical trials we conduct in Denmark every year.

Come and join a dedicated, passionate team that is encouraged to think and do things differently in order to create innovative solutions for our patients!

The CRA Manager is leading our Danish CRA team, responsible for hiring, training, coaching, development, performance and allocation of CRAs to our broad, innovative global trial portfolio. The CRA Manager ensures clinical monitoring activities related to investigator site qualification, initiation and trial conduct are performed in accordance with ICH-GCP, regulations and Novartis SOPs. The CRA Manager acts as country single point of contact for internal and external stakeholders and is member of the Nordic Trial Monitoring Leadership team.

Your responsibilities include, but not limited to:
• Collaborate with Nordic Trial Monitoring Head to implement country innovative practices and patient engagement tactics to advance clinical trial planning, execution and quality
• Is accountable for any country specific requirements, represents Denmark in the Nordic Trial Monitoring Leadership Team and acts as single point of contact for all internal and external stakeholders.
• Is strategically and operationally involved in allocating new trials during trial feasibility/allocation
• Liaises with local and global clinical teams to enhance Novartis relationship with clinical sites, to ensure site performance to trial commitments and delivery of quality monitoring
• Is accountable for monitoring quality by overseeing CRA performance through data analytics tools and other systems
• Collaborates with Clinical Study Manager (CSM) Manager for monitoring trends that require targeted training and/or development of CRAs to deliver to trial KPI (Key Performance Indicator) and KQI (Key Quality Indicator) goals
• Performs ongoing assessment and allocation of monitoring resources within Country to ensure balanced CRA workload for quality monitoring
• Is responsible for managing and addressing CRA performance targets per defined Trial Monitoring key trial and quality performance indicators, including managing site recruitment commitments, timely data entry and issue resolution KPIs.

Minimum requirements

What you’ll bring to the role:
• A degree in scientific or health discipline required and advanced degree preferable
• Fluent in both written and spoken English and Danish
• Minimum 7 years’ experience in clinical research - planning/executing and/or monitoring clinical trials with robust experience in project management and team leadership
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
• Excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues.

Desirable requirements:
• Demonstrated negotiation and conflict resolution skills, advanced coaching skills
• Strong interpersonal and communication skills as well as a high mental ability

You’ll receive:
Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.

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