CRA MANAGER

Job Description We are a research-driven biopharmaceutical company.
Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world.
We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation.
Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
This role will be key to ensure strong monitoring in our clinical trials.
Under the oversight of the Head of Monitoring Resources or the CRD, 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.
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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.
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 Employees apply HERE Current Contingent Workers apply HERE Secondary Language(s) Job Description.
Gerente de Monitores Clínicos Más de 12 años de experiencia en investigación clínica Titulado de alguna carrera relacionada con el área de la salud Excelente inglés hablado y escrito Haber pasado por las posiciones de monitor y gerente de proyectos clínicos Preferible experiencia previa como People Manager.
Evidencia en la siguientes habilidades.
liderazgo, trabajo en equipo, desarrollo de personal, enfoque en resultados, manejo de tiempo, comunicación asertiva, trabajo crosfuncional, pensamiento estratégico, humildad para aceptar errores.
Search Firm Representatives Please Read Carefully  Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
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Where agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
Employee Status.
Regular Relocation.
No relocation VISA Sponsorship.
No Travel Requirements.
No Travel Required Flexible Work Arrangements.
Hybrid Shift.
Not Indicated Valid Driving License.
No Hazardous Material(s).
no Job Posting End Date.
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Requisition ID.
R