The KEMRI-Wellcome Trust Research Programme (KWTRP) conducts high quality clinical trials focussing on diseases that present a high burden for developing countries. The Clinical Trials Facility (CTF) oversees the design, strategy, coordination and governance of high quality phase I, II, III and IV clinical trials across Africa. The CTF is involved in both investigator-led and externally-led single and multi-centre trials involving drugs, vaccines, nutritional, behavioural and systems interventions. The CTF aims to maximise opportunities for learning and training in order to maintain a cadre of highly skilled and experienced African trials staff from all disciplines.
We are developing and evaluating vaccines against outbreak diseases caused by arboviruses (including yellow fever and rift valley fever) and plan to expand this work to other pathogens. The post holder will be responsible for planning, developing, implementing and coordinating operational and administrative aspects of these projects. The post is mentally demanding and involves a high level of communication among trial staff, with trial sites, study participants, regulatory bodies and the wider community. The post holder will need to be experienced and highly self-sufficient to manage a complex programme of research work.
This post is based at the KWTRP, which is a partnership between the Kenya Medical Research Institute, the Wellcome Trust and the University of Oxford, and a world-renowned health research unit. The KWTRP works together with scientists, health services and local communities to achieve better health, while also developing local scientific leadership and infrastructure
QUALIFICATIONS, SKILLS & COMPETENCIES:
- Ensure effective project plans are in place and operational for each trial and work proactively with the trial team to set priorities in accordance with applicable project plans, standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements; and maintain a register of risks and implement strategies to mitigate risk in collaboration with the QA manager.
- Establish systems to track trial progress, milestones and performance metrics.
- Provide efficient updates on trial progress to the PI and/or Head of CTF, with respect to project plans, trial budget and timeline management, recruitment, inventory management, and trial conduct.
- Oversee organizational structures, work schedules, task management and project milestones; be responsible for analysis, monitoring and evaluations of targets and strategic objectives; identify potential delays, bottlenecks and their effects on project deliverables; and implement strategies to ensure operational effectiveness.
- Lead study planning and start-up process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF) and study planning meetings.
- Supervise clinical trial coordinators to develop, track and report work schedules, task management and milestones and to ensure the alignment of these activities with the overall project priorities.
- Contribute to strategic planning and oversight of capital, operating budgets and expenditures for research grants and future grant applications in liaison with the finance and grants departments at KWTRP and the University of Oxford.
- Responsibility for ethics and regulatory document preparation and submissions, timely report submissions and communication with ethics and regulatory bodies.
- Develop or supervise development of Standard Operating Procedures (SOPs) for the projects together with the study team and conduct training/supervise training on SOPs/SIVs and ensure that clinical teams fulfil their roles and responsibilities.
- Determine communications needs, and plan and assess communications strategies and media interaction in accordance with KWTRP policies.
- Responsibility for the day-to-day running of the projects through the administrative team at KWTRP in Kilifi, and other trial sites where necessary; and liaise with KWTRP operations team for space planning and allocation of space for staff and visitors.
- Oversight and planning of key trial meetings and arrangements for visitors in liaison with KWTRP operations and key administrative staff.
- Responsibility for maintenance of study records and documents, their secure storage, and ensuring all data are filled out appropriately and documents are up to date.
- Coordinate monitoring and audit visits and ensure that all requirements are met including availability of documentation and relevant staff.
- Liaise with the KWTRP Community Liaison Group to develop and implement site and community engagement strategies.
- Represent the research project to relevant internal committees, external organizations and, where appropriate, funding agencies.
- Create high quality project reports for funding agencies and project partners.
- Effectively provide support to the PI and/or Head of CTF in the conduct of the trials.
- Participate in scientific and business meetings within the Clinical Trials Facility when required.
- A Masters in life sciences or equivalent from an accredited institution.
- A degree in nursing or life sciences, diploma in clinical medicine, or a Registered Nurse.
- At least 5 years’ experience in clinical trials, including 3 years’ experience that is directly related to the duties and responsibilities specified above.
- Exceptional project management skills, proficiency in using project management tools and the ability to manage multiple large projects simultaneously.
- Significant skills in leadership, organization, prioritisation, problem solving and decision making.
- Financially literate with sound knowledge of budgeting methodologies and resource management concepts including proven experience of preparing and monitoring budgets and financial reports
- Demonstrable experience in writing high quality reports and presentations in English, with evidence of being attentive to detail.
- Ability to network, communicate, be diplomatic and maintain strong local and international relationships within a multi-cultural environment and wide diversity of people, and have experience in resolving disputes.
- Knowledge of regulatory requirements and best practices in clinical trials
- Strong leadership, organisational and planning ability, with an ethical standpoint
- Strong interpersonal and communication skills (oral and written)
- Training in GCP and research ethics
- Training in Project Management or equivalent from an accredited institution