CRA Line Manager

Category:  Clinical Development
Location: 

Ciudad de México, Ciudad de México, MX

Are you passionate about clinical research? Do you have a knack for leading and developing teams? We are looking for a new CRA Line Manager to join our hybrid team in the CMRQ department, supporting the obesity team at Novo Nordisk. If that sounds like you, read on and apply today for a life-changing career.

 

Position Description
As a CRA Line Manager at Novo Nordisk, you will:

  • 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.

 

Required Qualifications
We are looking for a candidate who possesses the following qualifications:

  • University Degree, preferred in Life Sciences or related like Pharmacobiologist Chemist, Pharmaceutical Engineer, Biologist, etc.
  • 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, supporting the obesity team, is responsible for running all clinical development activities from initial planning of clinical trials to authority submission. We investigate patients' reactions to new drugs, compare new drugs to existing products, and run a set of pre-specified trials in human beings. Our team provides biostatistics and programming, clinical reporting, data management, epidemiology/real-world evidence, and clinical pharmacology resources to all development projects. With a hybrid work model, you will have the flexibility to work both remotely and on-site, ensuring a balanced and productive work life.

 

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. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. 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. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're life changing.

 

Contact
To complete your application, click on "Apply now", attach your CV in English and follow the instructions.


Deadline
Please apply before Nov 3rd, 2024


 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.