Job Description
This role will be key to ensure strong monitoring in our clinical trials.
Under the oversight of the Clinical Research Director, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP.
As line manager the role is critical to continuously develop key talents by providing training, support and mentoring to the CRAs and properly manage situations of low or non-performance.
The role will work at the country level with other local stakeholders e.g.
TAH, CRM to ensure alignment and development of the country capabilities.
The role will collaborate with country PLMs to ensure alignment across all monitoring functions.
The person contributes to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.
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.
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.
Behavioral 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:
Minimum of 5 years´ experience within clinical research.
Minimum of 3 years' experience as CRA monitoring clinical trials.
Line management experience preferred or at the minimum team leader experience.
Educational Requirements:
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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