Position Title CRA Group Head Sweden and Norway

Job ID	131348BR
Division	Pharma
Business Unit	General Medicines - Region Europe
Country	Norway
Work Location	Oslo
Company/Legal Entity	NOV NORGE NOR
Functional Area	Development & Medical
Job Type	Full Time
Employment Type	Regular
Job Description	Provide leadership and line management to CRAs and supporting staff within his/her operating unit in Scandinavia to achieve production of high quality clinical trial data to support the goals of Clinical Development Plans consistent with international regulatory requirements for new drug applications and provide proper education/training programs and development plans to ensure proficiency in the Scandinavian 1. Hire, train and supervise Novartis own CRAs, Third party and mixed model CRAs and Project Assistants 2. Assure that required level of knowledge and skill is present and trials sites are monitored as per SOPs. Identify skills and competency gaps. Work with training team to develop training plans and coordinate training as needed 3. Contribute to develop business opportunities by identifying new sites for participation in assigned clinical trials 4. Ensure that prevailing legislation, GCP and SOP requirements are fulfilled 5. Allocate resources to trials in collaboration with the Scandinavia Project managers and Scandinavian ICRO Manager 6. Provide and maintain training plans and development plans of Novartis own CRAs and Project Assistants and training plans for Third party and mixed model FTEs 7. Assure that required level of knowledge and skills is present and trials sites are monitored as per SOPs/WPs. Identify skills and competency gaps and coordinate training as needed 8. Co-monitoring with CRAs and MVR review to ensure adherence to SOPs/WPs and ensure efficient and high quality work 9. Support and coaching the group members in their tasks in clinical trials 10. Maintain relevant knowledge of therapeutic areas and investigational products 11. Co-responsibility for KPIs/Metrics and follow-up of KPIs/Metrics in their group 12. Build and maintain relationship to internal and external collaborators 13. Co-responsible for the continuously improving working environment to maintain stability in ICRO and retain valuable people 14. Responsibility for specified tasks/projects within ICRO (please see appendix 1) 15. To co-operate with Commercial Operations where appropriate 16. Review and approve of confirmation of Investigator site readiness for initial drug shipment for new protocols 17. Accountability for documentation, training and implementation of all policies and guidelines within their employees to ensure full compliance (e.g. NP4, Code of Conduct, Corporate Citizenship, HSE, D&I, etc.)
Minimum requirements	A degree or equivalent in a scientific or health care discipline. Fluent in either Danish, Norwegian or Swedish and fluent in English (oral and written). 1. Minimum 6 years of experience in clinical research (with GCP education – LIF/LMI or equal, preferably 3 years monitoring experience 2. Expert in a specific disease area with established contacts in the medical community. 3. Excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues. 4. Expert knowledge of international standards (GCP/ICH), international (FDA, EMEA) , local regulations and Novartis standards. 5. Proven ability to manage teams and complex communication in Scandinavia and in the global organization.