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Trial Manager

Company AHRI
Reference # SOM/TRIALMAN/FEB/2020
Published 05/02/2020
24 Months
Location Mtubatuba, South Africa
Duration _24_Months
Introduction
This role will provide line management support to the Trial Coordinator, reporting to the Principal Investigators. The incumbent will have overall oversight of the field research team in the implementation of the Insika Yomama Trial. This position is based in Mtubatuba with regular visits to Durban.
Job Functions Research,Research and Development
Industries Academic,Healthcare,Ngo / Non-Profit,Pharmaceutical / Medical / Healthcare / Hygiene,Research,Science & Technology
Specification
The role will provide logistical support for the weekly and quarterly trial meetings, as well as be responsible for the coordination and drafting of Adverse Events/Serious Adverse Events (AE/SAE) reporting for the Principal Investigators, including reporting to the Chair of the DSMB within 24 hours for SAEs, for ethics and Data and Safety Monitoring Board (DSMB) submission. They will also have overall oversight, supporting the Trial Coordinator to ensure quality of the assessment, recruitment, therapy and support call data. They will also support the Trial Coordinator, and the seconded trial psychologist and trial social worker, to achieve quality in the implementation of the intervention and control arms of the trial.
This role will oversee and manage the AHRI Insika Yomama budget and resources, with the support of the AHRI Grants Officer assigned to the trial. They will ensure compliance with the Sponsor (University of Oxford), and research ethics committees’ (OxTREC and HSRC) and Department of Health requirements for reporting, as well as the quarterly AE/SAE and annual data and safety reporting to the DSMB and ad hoc reporting to the Trial Steering Committee (TSC). This role includes the preparation and submission of all regulatory and ethics submissions, reviews and update reports. The incumbent will also be responsible for the preparation and distribution of agendas and the taking of minutes at all trial meetings.
The Trial Manager will also lead and oversee the development of the protocol for the measurement of the child development primary outcome, and conduct the training on the same, to ensure meaningful and high quality data for the primary outcome of the trial.
The incumbent will be responsible for monitoring the implementation of the approved organisational study-specific standard operating procedures, as well as the regular review and updating of the same. The Junior Trial Manager will be expected to contribute to manuscript preparation for publication and present research output at conferences. This role can involve some remote working, as well as work from the Durban AHRI offices.
Requirements
Minimum Qualification

1. A PhD or in the final stages of submission in either a psychology/public health/medicine or related sciences
2. Detailed knowledge and training in clinical trial design
3. South African experience in implementation including:
a. development of ethics protocols and recertification submissions,
b. design of assessment protocols,
c. management of projects in REDCap,
d. development and design of automated fidelity checks, and,
e. experience in assessment specifically related to maternal mental health and child cognitive and behavioural development in the first 2 years of life
4. Current GCP certification
5. Advanced statistical expertise or understanding of the interpretation of complex statistical analyses (to manage and support the trial statistician)

Minimum Experience

1. A post-graduate qualification in the subject area of maternal mental health
2. A qualification in the area of child development would be an advantage
3. At least 3 years’ experience of health, economic, or behavioral research studies, preferably in maternal mental health and child development, of which, 2 years should be in a clinical research setting.
4. Experience and proven success at grant writing
5. Experience of working in rural settings
6. Competence in ethics submissions and correspondence
7. Proven ability in the preparation of publications, as evidenced by a publication record
8. Proven ability in report writing for internal and external stakeholders such as TSC, DSMB, funder or for investigator meetings
9. Experience in clinical database programming using REDCap or similar
10. Experience in training and supervision of fieldworkers

Please note that only those candidates who meet the minimum requirements will be considered. AHRI is fully compliant with South African labour law and is committed to employment equity. This position is open to South African applicants and valid work visa holders.

AHRI reserves the right in special circumstances to accept late applications or to extend the above date in order to facilitate further searches. Furthermore, AHRI reserves the right not to make an appointment. Please consider your application unsuccessful if you have not been contacted within 4 weeks of the closing date
Job Closing Date 18/02/2020
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Last Updated: 11 days ago [20.02.01.00]
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