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.
Description:
REPORTS TO:
- Programme Executive Director
- Departmental Chair Clinical Research
DIRECTLY SUPERVISES:
- Monitoring staff in clinical trials facility.
- Data managers, project managers.
- Fieldworkers, nurses, clinical officers and medical officers on specific trials.
INDIRECTLY SUPERVISES:
BUDGET AND RESOURCE RESPONSIBILITY:
- Departmental budget
- Clinical research trials facilities including equipment and machinery
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
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