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DNDi GARDP Southern Africa was established in 2018 and is a non-profit South African company that aims to provide health care services by developing safe, effective and affordable new health technologies that tackle global or regional public health priorities, with a contribution to the fight against antimicrobial resistance and diseases that affect vulnerable and neglected populations.
GARDP’s mission is to work in partnership with the public and private sectors, to develop and deliver new treatments for bacterial infections where drug resistance is present or emerging, or for which inadequate treatment exists.
Purpose of the position
The CTM will play an important role in the development of treatments to combat anti- microbial resistance (AMR). S/he will provide support to coordinating regional clinical activities and developing clinical trial capability for the Global Antibiotic Research & Development Partnership (GARDP) portfolio of clinical projects. The initial focus will be on supporting studies within the established portfolio (neonatal sepsis, paediatric and gonorrhoea) and with the opportunity to support for set up our new serious bacterial infection project where possible.
This role will be responsible for coordinating regional clinical trial activities from contribution to development of study documents, site capability and feasibility assessments, site set-up and coordination of monitoring from site assessment to closeout in South Africa and regionally. The post is based in Cape Town or Johannesburg South Africa with occasional travel to Europe, or within the Southern African region expected.
Tasks and Responsibilities:
Coordination of the clinical trials conducted by GARDP in the Southern African region
Day to day management and/or oversight of clinical research associate(s) involved in the studies, including review of monitoring reports, identifying and resolving issues identified during the monitoring visits
Provide backup, support and advice/mentorship for trial monitors including co-monitoring and substitute monitoring as and when required
Contribute to safety reporting activities .g. Serious Adverse Events (SAE) reporting including with sites, ethics and regulatory agency as specified by safety management plan
Ensure coordination of local monitoring and data management activities and provide support to the trial data management team including Trial Statistician and Data Managers
Liaise with GARDP and/or DNDi GARDP Southern Africa Finance & Administration for trial related activities and payments
Support and respond to requests from trial site team members and PIs on trial related matters
Arrange trial specific and applicable training for trial site teams and identify training needs for collaborative sites.
Management of local vendors: i.e. local courier and local labs
Development of clinical trial capability
Support site identification, assessment and development of capability to support existing and new clinical projects and studies.
Provide clinical operation expertise to the planning and set-up of Southern African clinical trial sites and laboratory networks for new projects and studies
Ensure regulatory compliance for projects
Be familiar with drug development regulatory requirements, documentation and processes for major international agencies and have thorough knowledge of the clinical development process.
Ensure projects follow GCP and applicable regulatory requirements and keep appropriate documentation
Participate in preparation and submission of regulatory documentation for allocated countries
Prepare and review clinical SOPs and other standard documents required for clinical trials
Contribute to the set up and to review of GARDP systems related to clinical operations as appropriate
Manage and develop project reporting systems
Develop project schedules with the Project Leader and the Project Team
Monitor milestones for project evaluation with the above project team
Interact with study site teams on a regular basis to ensure that projects achieve set milestones
Collect data and information to enable the Project Lead and Head DNDi GARDP Southern Africa Office to make effective and cost-efficient use of GARDP/DNDi resources
Provide logistical support and tracking for all trial resources/materials with the trial monitors, trial managers and site investigators
Liaise with the project consultants and collaborators within the project network
Support for Project team and DNDi GARDP Southern Africa office objectives
Play a full role in the GARDP R&D team and to be an active member of the GARDP global team, as well as the DNDi GARDP Southern African team
Under supervision of the Project leader and the Head of DNDi GARDP Southern Africa, be able to represent GARDP and DNDi GARDP Southern Africa to the relevant medical authorities (Ministries of Health and drug regulatory authorities) as and when needed
Under supervision of the GARDP Project leader and Head of DNDi GARDP Southern Africa to be able to represent GARDP and DNDi GARDP Southern Africa in both scientific and communication events as and when needed
Help to build long term relationships with key research centers and individual investigators to support GARDP and Southern Africa office’s objectives and presence in the region
Develop and maintain the skills required for delivery of all aspects of clinical trials
Develop and/or build an understanding of the specific challenges of antibiotic clinical trials, in particular in a Southern Africa setting
Maintain an awareness of developments in clinical development, the regulatory environment and specifically in the designated disease areas and relevance to Southern Africa.
Support the building of the knowledge base by feeding insight and intelligence to the, respective GARDP project team and DNDi GARDP Southern Africa
The CTM reports directly to the Head of DNDi GARDP Southern African Office with additional reporting to the Clinical Operation Leader and the relevant GARDP project leads.
To work closely with relevant GARDP disease teams
To work with the broader DNDi GARDP Southern African team
To work with local and international partners including investigator site teams, local and international project partners, CROs and others as required
Core Skills and Attributes
Ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
Clear and systematic thinking that demonstrates strong judgment and problem-solving competencies
Strong communication skills in multicultural, multi-lingual environments
Strong interpersonal skills and the ability to work effectively as part of a multicultural international research collaborations
Proven ability to work effectively in a team environment and matrix structure
Very well organized and structured with strong analytical skills
Ability to exercise high degree of independence to support program delivery
Ability to interact with internal and external stakeholder
Excellent knowledge in software packages used in word processing, presentations, management and finance
Fluent in English and proficient in local language(s) would be an added advantage
DNDi - GARDP Southern Africa Leadership Competencies
Bachelor’s life sciences, pharmacy of nursing degree required S/he will have high level scientific qualifications in a relevant discipline with a proven record of organizational skills. Degree should be in a scientific, medical, business, or drug development discipline
Masters degree in a relevant clinical field maybe added advantage
At least 6 years’ experience in clinical R&D and GCP training
Experience of working in public and private sector is highly desirable
Experience and understanding of issues related to antibiotic treatment of bacterial infections would be an advantage
Fully remote, preferred Cape Town thereafter Johannesburg or Durban. The candidate must be able to come to Cape Town
Please submit your application using the online form
Deadline for application: Accepting applications until September 26th 2021
All candidate will be reviewed after closing date
Only shortlisted candidates will be contacted
R56000pm - R67000pm plus benefits (South African Rand)
Note: Never pay for any training, certificate, assessment, or testing to the recruiter.
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