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Job Description
• Work allocation, staff development and performance appraisal.
• Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources.
• Work with CRAs, PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.
• Interacts with sites as needed to resolve site or CRA operational issues to meet commitments in a timely manner in coordination with the study CRM.
• Attend local Investigator Meetings if requested to.
• Interface with GCTO partners on clinical trial execution.
• Escalates site performance issues to CRM and Clinical Research Director CRD. • People and Resource Management: o Manage CRA – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions. o Support and resolve escalation of issues from CRAs. o Liaise with local HR and finance functions as required. o Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work. o Provides training, support and mentoring to the CRA to ensure continuous development. o Ensures CRA compliance to corporate policies, procedures and quality standards
Current Contingent Workers apply
Language(s) Job Description:
CORE Competency Expectations:
• Ability to work independently and in a team environment
• Excellent people management, time management, project management and organizational skills
• History of strong performance
• Skills and judgment required to be a good steward/decision maker for the company
• Fluent in Local Language and business proficient in English (verbal and written)
• Excellent working knowledge of all applicable ICH/GCP regulations and Good Documentation Practices and ability to work within these guidelines
• Expertise in and excellent working knowledge of core trial management systems and tools Behavioural Competency Expectations:
• High emotional intelligence
• Strong leadership skills with proven success in people management
• Excellent interpersonal and communication skills, conflict management
• Demonstrated ability to build relationships and to communicate effectively with external customers (e.g. sites and investigators)
• Influencing skills
Experience Requirements: Required:
• Minimum of 10 years´ experience within Clinical Research
• Minimum of 5 years’ experience as CRA monitoring clinical trials
• Line management experience preferred or at the minimum team leader experience Educational Requirements: Required:
• Bachelor’s degree in Science Preferred:
• Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology
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