Clinical Operations Manager

2 weeks ago

Johannesburg, Gauteng, South Africa Novo Nordisk Full time
Clinical Operations Manager

Category:

Clinical Development
Location:Johannesburg, Gauteng, ZA- Would you like to be part of our Clinical Development Center South Africa (CDC-ZA) management team as we set out on a journey into new and exciting therapeutic areas and ways of working? Do you want to develop further as a people manager within the clinical trials field? Then you could be our new Clinical Operations Manager in Johannesburg, South Africa.


The Position

  • As a Clinical Operations 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 crossteam collaboration e.g. with other 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 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.

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. As a person, you should be a team player with strong leadership and timemanagement skills, and quality mindset.
  • To be successful in this role, we expect you to also meet the following criteria:
  • Strong clinical operations experience for phase II and III trials including minimum 5 years of on-site monitoring
  • 25 years of line management experience for commercial trials (i.e. not NIHfunded) is required
  • Previous experience in Trial Manager / Clinical Project Manager roles is desired
  • Ideally you also have experience within diverse therapy areas, especially those relevant to Novo Nordisk portfolio
  • Proficiency in English both oral and written
  • We are looking for someone who enjoys traveling as the job involves site visits demanding 3040% of your working time. At the same time, you are expected to be present in the office for department and project meetings. We offer some flexibility with 2 days/week as homebased.
    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, Alzheimer's Disease, NASH, Sickle Cell Disease) that Novo Nordisk is investing in.
  • You will be reporting to a Therapy Area Head responsible for clinical trials in a specific therapy area. You will have 610 CRAs as your direct reports. Your wider team also includes CTAs, Trial Managers, Clinical Quality & Training 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. That's 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 it's a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 60,000 employees. Together, we go further. Together, we're life changing.
    ContactDeadline*
  • 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

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