Clinical Development Centre

2 weeks ago

Johannesburg, Gauteng, South Africa Novo Nordisk Full time
Clinical Development Centre - Project Manager

Category:

Project Management & Agile
Location:Johannesburg, Gauteng, ZA- Are you ready to make the next step in your professional development in a global expanding company? Join Novo Nordisk as Clinical Development Centre (CDC) Project Manager and get a life-changing career- This role is based in Johannesburg, South Africa and directly reports to CDC Clinical Research Manager.


The position

  • As CDC Project Manager, you will be responsible for Project planning and management for assigned trial/research projects for the CDC, and ensuring deliverables are met as per project timelines, within budget and complying with Protocol, regulatory requirements, GCP (Good Clinical Practice) and NN SOPs (Standard Operating Procedures). You will be leading several project teams, setting projectspecific strategies and providing direction to ensure successful project delivery. Furthermore, you will do proactive risk identifications and mitigation plans at CDC level while being wellversed with Clinical reporting tools and you will comonitor with based on project risks.
  • Your main accountabilities will be:
  • Responsible for driving the clinical projects, which includes planning, conducting and coordinating of project activities, providing operational and therapeutic expertise to the project, achieve deliverables within agreed timelines and in accordance with scientific, quality and regulatory requirements (70%)
  • To ensure effective communication of all trial/projectrelated issues between HQ, CDC and region and other Internal/external stakeholders (20%)
  • Responsible for representing CDC countries in relevant study meetings: Trial Group Meetings, Monitor meetings, Investigator meetings, and Study Result meetings (10%)
  • Overall responsible for project planning, management and execution of assigned clinical trials in the CDC in accordance with applicable regulatory requirements, NN Protocols and SOP's.
  • Ensure preparation and submission support of local Clinical Trial Applications to Health Authorities as soon as possible in order to obtain all necessary regulatory approvals within a defined timeline. Ownership of trialrelated meetings with the CDC trial team.

Qualifications

  • You have a minimum Bachelor's degree level, preferably in life science, pharmacy or nursing qualification with a minimum of 3 years of working experience within trial management and monitoring clinical trials in accordance with ICH GCP methodology in a commercial company.
  • You will also need to have:
  • Knowledge of clinical trial methodology
  • Knowledge of the clinical trials environment
  • ICH GCP, NN SOPs
  • Good working knowledge of electronic clinical trials systems
  • CTMS, EDC, IWRS, electronic TMF
  • Computer literacy and proficiency in MS Office

About The Department

  • Clinical Development Centre South Africa (CDC South Africa) is a dynamic unit in the Clinical Research organisation. The CDC South Africa is responsible for planning, execution and finalisation of clinical trial activities e.g., project management and administrative tasks related to the conduct of clinical trials. In CDC South Africa we are approximately 43 highly skilled and passionate CRAs, Clinical Project Managers and Clinical Trial Administrators. We value an open, trustbased and creative working environment as well as a great team spirit. Our working environment is characterised by interesting and demanding assignments and continuous professional development opportunities.
    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 50,000 employees. Together, we go further. Together, we're life changing.
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  • 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.

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