Job Description

This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, 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 situation of low or non-performance. The role will work at country level with other local stakeholder e.g. 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 Extent of Travel: up to 50% 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 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: Required: 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: Required: Bachelor’s degree in Science ​ Preferred: Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology #EligibleforERP MRLGCTO NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholder