Clinical Trial Operations Manager
AJ Personal
Johannesburg, Gauteng, ZA
4d ago
source : Work-Force

Key performance areas : Strategic management and coordination of cross-cutting of services for clinical trials within the portfolio, specifically laboratory, pharmacy, regulatory compliance and data management :

  • Ensure full awareness of current and planned study activity across a therapeutic area and provide therapeutic and operational expertise to support portfolio, program and study design
  • Proactively identify upcoming study and portfolio needs and effectively coach and guide project and support staff to ensure success (e.
  • g. team preparedness to meet resource demands, key data cuts etc.)

  • Provide therapeutic and operational experience to guide and influence development of early study strategy and planning by supporting application of lessons learned from all studies on a program
  • Conduct regular reviews and evaluation of project and program metrics and support development of appropriate action plans and mitigation strategies in order to meet customer goals.
  • Monitor progress across studies within a portfolio to ensure that consistent issues or themes ( (quality, consistency and efficiency) are identified and actively participates in the development of appropriate actions, solutions and lessons learned to improve performance
  • Ensure high-quality and timely delivery of clinical projects across the portfolio through ongoing review and evaluation of project performance, through provision of support, direction and therapeutic / operational expertise to project teams
  • Ensure financial oversight and management of activities within agreed donor budgets
  • Risk assessment and management
  • Stakeholder management and reporting

  • Actively participates in program and project governance meetings to ensure programs meet established timelines
  • Escalates appropriately within partnership governance structure and demonstrates ability to resolve challenges within the organization and across various external stakeholders
  • Staff and self-management

  • Staff management including direct oversight of laboratory, pharmacy, and data management services that support clinical trials within the portfolio.
  • Develop team and individual work plans to ensure delivery within timelines and budget
  • Provide supervision, support, guidance, mentoring, coaching and counselling to your team on a day to day basis.
  • Manage teams in accordance with Ward 21 protocols, standard operating procedures and supporting documents, as well as organization's policies and applicable legislation.
  • Required minimum education and training

  • Bachelor’s Degree in Life Sciences, Medicine or Nursing or equivalent qualification / experience
  • Required minimum work experience

  • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Minimum 5-7 years senior management experience of complex projects
  • Experience in clinical operations
  • Strong software and computer skills, including MS Office applications
  • Basic understanding of employment legislation or general people management
  • Proven ability to coach, mentor and motivate others in this field
  • Desirable additional education, work experience and personal abilities

  • Postgraduate degree in related field.
  • High level of industry awareness and ability to recognise bigger picture’
  • Demonstrated leadership, management and change management ability, including the ability to manage a diverse team.
  • Proactive agent influencing positive change with external stakeholders with the ability to develop and maintain stakeholder relationships at all levels of the organisation and partner organizations.
  • Positive, energetic team leader with an ability to adapt to complex situations, manage stress, and deliver goals pro-actively.
  • Organised with a thorough and accurate approach to work, attention to detail
  • Ability to proactively identify issues and risks, and put in place mitigation and improvement measures where needed
  • Empathetic with the ability to listen sensitively to employee or client issues and offer unprejudiced counsel, guidance and support where necessary
  • Excellent communication skills
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