The 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 Nordisks SOPs and local procedures and ICH GCP.
- Support/troubleshooting CRAs 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.
In order to be considered, you need to hold academic Bachelors 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.
About The Department
Working with the clinical trial team in South Africa and collaborating across SEEMEA and International Operations, you will join an expanding dedicated local team of Clinical professionals on a mission to create better treatments and care for patients with Diabetes, Obesity, Rare Disease and the new therapeutic areas (Cardiovascular Diseases, Alzheimers Disease, NASH, Sickle Cell Disease) that Novo Nordisk is investing in.
You will be reporting directly to the CDC-ZA Director together with 4 other Clinical Research Managers and 2 Clinical Quality & Training Managers. You will have 10-15 CRAs as your direct reports. Your wider team also includes CTAs, Trial Managers, and a Start Up group.
Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear, and balancing what is important at different stages of our career is never easy. Thats why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and its a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 50, 000 employees. Together, we go further. Together, were life changing.
Contact
Please apply with your CV and we will be in touch with you regarding the next steps.
Deadline
Apply before the 10th of August 2023.
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, were life changing.
