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Job Purpose: Responsible for providing leadership and coordination of all clinical trials activities in the Programme. Also to oversee and coordinate monitoring, project management, data base support and sponsorship for investigator-led clinical trials on Phase I, II and III.
This position will report to the Programme Executive Director and Departmental Chair Clinical Research.
This post will be monitoring staff in clinical trials facility, Data managers, project managers, fieldworkers, nurses, clinical officers and medical officers on specific trials.
- 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.
SKILLS AND COMPETENCE:
Qualifications and Experience: Essential Requirements:
- Bachelors degree in medicine, science, public health or a related field.
- Masters degree in a related field is an essential requirement.
- A PhD or post-graduate medical qualification relevant to clinical research is required.
- Leadership experience in clinical trials or clinical research.
- 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.
- Familiarity with biomedical sample collection and handling.
- Regulatory experience
- Evidence of supervisory ability and negotiation skills.
- 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 organization ability.
- Confidentiality, integrity, patience and calm disposition.
- Team working and ability to work in a multi-cultural environment.
To apply for this post you must be a registered user. Log into your account then go to Vacancies, view the post and click on the button: "Apply for this job".
All applicants are required to state their current/last salary.
Candidates must supply an email and telephone contact that will be used when offering interviews. Only shortlisted candidates will be contacted. Shortlisted candidates shall be required to produce ORIGINALS of their National Identity Card, academic and professional certificates, original transcripts and testimonials, detailed curriculum vitae and valid clearance certificate(certificate of good conduct) during the interviews.
The application closing date is 31st July, 2015.
KEMRI-Wellcome Trust Research Programme (KWTRP) is an equal opportunity employer. Direct or indirect canvassing will lead to automatic disqualification. KWTRP does not charge a fee at any stage of the recruitment process (application, interview, meeting, processing, training or any other