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