Clinical Research Team Manager

hace 4 semanas


Xico, México Novo Nordisk A tiempo completo

About the Role


As a CRA Line Manager at Novo Nordisk, you will play a key role in ensuring the successful delivery of clinical trials. Your responsibilities will include managing a team of Clinical Research Associates, overseeing resource allocation, and monitoring staff utilization.


Key Responsibilities



  • Manage a team of CRAs to ensure compliance with ICH/GCP, SOPs, and local regulations.
  • Oversee resource allocation and monitor staff utilization for clinical projects in the medium and long term.
  • Build rapport with monitors, oversee their workload, and coordinate CRAs in alignment with the clinical area.
  • Conduct performance and competencies appraisals, provide training, coaching, and mentoring to the team, and develop and train staff focusing on individual CRA needs.
  • Hire, onboard, and integrate new CRAs, and act as the first point of contact for insourced monitors and oversee CRO contracts to ensure compliance.
  • Communicate regularly with TA Lead, Clinical Operations Head, and other relevant stakeholders about CRAs' performance and potential issues, manage the quality of assigned staff through regular review of quality metrics and follow-up, and promote behavior changes aimed at improving performance and competence acquisition while aligning employees to departmental standards and new processes, ensuring compliance with NN Way and Business Ethics.

Requirements



  • University Degree, preferred in Life Sciences or related fields.
  • Minimum 8 years of demonstrated proficiency in Clinical Research, with the technical skills and knowledge to ensure compliance with ICH/GCP, SOPs, and local regulations.
  • Desirable: 1.5 years of experience as a people manager/coaching a team to work towards common goals, provide constructive feedback, and develop talent.
  • Availability to travel 30-40% of the time.
  • Advanced English proficiency.

About the Department


The CMRQ department is responsible for running all clinical development activities from initial planning of clinical trials to authority submission. Our team provides biostatistics and programming, clinical reporting, data management, epidemiology/real-world evidence, and clinical pharmacology resources to all development projects.


Working at Novo Nordisk


Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them.



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