Head of Clinical Trials at KEMRI-Wellcome Trust

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