Clinical Research Manager at Novo Nordisk

he Position

As a Clinical Research Manager, you will be responsible for the line management, coaching, mentoring and development of CRAs across South Africa. You will oversee CRA performance, support them in planning, execution and management of assigned tasks in accordance with departmental productivity expectations. Additionally you are expected to be driving cross-team collaboration e.g. with other CRA Line Managers, CDC Head and medical team.

Your daily tasks include more specifically:

• Coach CRAs offsite and onsite on monitoring skills and site management aspects, as well as identify other training needs, prepare/support the development of training materials to meet those needs, and provide training as required – may be together with the Clinical Quality & Training Manager.
• Ensure trial conduct, data collection and documentation are conducted by reporting CRAs, professionally and to a high standard, in accordance with Novo Nordisk’s SOPs and local procedures and ICH GCP.
• Support/troubleshooting  CRA’s in planning and execution of various project tasks e.g. submissions, site activation, planning of monitoring visits, managing quality issues at sites, site specific recruitment and retention issues, site management related issues, readiness for audits and site inspections, etc.  
• Active interactions with external stakeholders during various meetings (e.g. meeting Investigators during various site visits, local Investigator meetings, local congress, etc.) and manage expectations.
• Active participation in management meetings and other local meetings, input to local strategies.

Qualifications

In order to be considered, you need to hold academic Bachelor’s degree or higher in the discipline of Life Sciences, Medicine or Pharmacy. Proficiency in both oral and written English is required. As a person, you should be a team player with strong leadership skills and quality mindset.

To be successful in this role, we expect you to also have the following working experience:

• Minimum of 5 years of overall experience within clinical operations for phase II and III trials: as a Line Manager for CRAs or Trial Managers for the last 2+ years in your current role, and as a CRA/Trial Manager in your previous roles.
• Performed trainings and worked with performance management, including underperforming reports.
• Has experience with audits/inspections, performed investigator meetings and quality oversight visits.
• Worked in risk-based monitoring setting.
• Strong understanding of metrics and good working knowledge of electronic clinical trials systems – COSMOS, RBQM, EDC, IWRS, electronic TMF.