Clinical Research Associate (CRA) Manager - Remote

Responsibilities

• 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.
• Works 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.
• Attends local Investigator Meetings if requested to.
• Interfaces with GCTO partners on clinical trial execution.
• Escalates site performance issues to CRM and Clinical Research Director CRD.

Qualifications, Skills & Experience

• 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).
• Expertise in and 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.

Behavioral Competencies

• 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).
• Demonstrated influencing skills.