JOB PURPOSE:
Responsible for providing leadership and coordination of all clinical trials activities in the Programme, and to oversee and coordinate monitoring, project management, data base support and sponsorship for investigator-led clinical trials on Phase I, II and III. The post would best suit a doctor with clinical research experience with capacity to develop their own research interests as well as support clinical trials led by colleagues.
KEY RESPONSIBILITIES:
Responsibility for strategic direction of the clinical trials platform.
Planning the overall budget and setting targets for development of the platform on a yearly basis, and negotiating and agreeing the plans with the Scientific Departments Committee responsible for overall scientific strategy in the programme.
Negotiating with prospective funders and PIs regarding proposed trials, their budgets and conduct.
Line managing the team of Line managing the team of monitors, project managers and data managers based in CTF.
Reviewing progress of clinical trials against internally set and contractual milestones.
Communicating with trial sponsors to ensure compliance to applicable regulations, and applying corrective and preventive action.
Providing input on clinical trials aspects of developing proposals and funding applications.
Overseeing the management and governance of clinical trials conducted by the Programme including trial monitoring and study coordination.
Coordination with regulatory affairs, surveillance and clinical service departments.
Responsibility to ensure trials are run to a high standard and delivered on schedule.
Membership of a Data Governance Committee and a Centre Scientific Committee.
QUALIFICATIONS AND EXPERIENCE:
Essential Requirements:
Bachelor’s degree in medicine, science, public health or a related field.
A PhD or post-graduate medical qualification relevant to clinical research is required.
Experience in clinical trials or clinical research.
Leadership experience in clinical trials, clinical research or clinical practice.
Extensive experience in medical, business, the NGO sector, international, academic or research organizations (i.e. at minimum ten years of experience and ideally 15 to 20 years).
Demonstrated ability to manage complex projects of >6months in duration demonstrating leadership in these projects
Computer literacy with proficiency in hospital systems and Microsoft applications
Experience of line management and delivery of projects with multiple external partners
Desirable Requirements:
Medical qualification with registration to practice as a doctor in Kenya
Familiarity with biomedical sample collection and handling
Regulatory experience
COMPETENCIES:
Evidence of supervisory ability and negotiation skills
Evidence of an ability to operate in a federalized environment with decentralized authority.
Strong skills in budgeting, development and oversight of project proposals, leadership of meetings, and writing skills.
Ability to work across cultures and evidence of communications skills in that context.
Willingness to respond within tight timelines and to cope with changing assignments.
Excellent diagnostic, analytical and investigative skills
Strong leadership skills and managerial ability
Strong planning, administrative and organisation ability
Confidentiality, integrity, patience and calm disposition
Team working and ability to work in a multi-cultural environment

Apply via :

careers.kemri-wellcome.org