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Job Description
Responsibilities include, but are not limited to:
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: Manage CRA – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions; Support and resolve escalation of issues from CRAs; Liaise with local HR and finance functions as required; Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work; Manage local conflicts between resource and work; Provides training, support and mentoring to the CRA to ensure continuous development; Ensures CRA compliance to corporate policies, procedures and quality standards
Expectations:
Bachelor’s degree in Science
Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology
Minimum of 5 years´ experience with in Clinical Research
Minimum of 3 years’ experience as CRA monitoring clinical trials
Line management experience preferred or at the minimum team leader experience
Qualifications, Skills & Experience/ 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
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
Traveling 50%
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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