Clinical Trial Manager

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.

DNDi GARDP Southern Africa represents the interests of the Drugs for Neglected Diseases initiative (DNDi) and The Global Antibiotic Research & Development Partnership (GARDP) in the region. DNDi & GARDP are not-for-profit Swiss foundations that have a shared vision of public health-needs driven research and development that ensures equitable and sustainable access to affordable treatments. For the ultimate benefit of the populations served by GARDP and DNDi, both organizations have a strong interest in sharing knowledge and resources, exemplified by this joint Southern African office.

DNDi focuses on discovering and developing treatments for neglected patients. Since its inception in 2003 DNDi has developed eight new treatments for malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, paediatric HIV with several new drug candidates in the R&D pipeline. Its objective is to deliver 16 to 18 new treatments by 2023, ensure equitable access to these treatments, and build a robust pipeline of new drug candidates. **

GARDP was initiated in 2016, incubated through a close collaboration between the World Health Organisation and DNDi. 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. The current focus areas are sexually transmitted infections (eg. gonorrhoea), antibiotics for children (neonatal sepsis and paediatric infections) and serious bacterial infections in hospitalized adults, and the aim is to deliver 5 new treatments by 2025.

Description

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

Personal

• 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

Reporting line

• The CTM reports directly to the GARDP Project Lead and has a dotted line to the Head of DNDi GARDP Southern African Office

Interactions

• 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

Job Requirements:

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

• Forward thinking
• Respect
• Reliability
• Recognition
• Care
• Effectiveness

Education

• 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
• GCP Training

Experience

• 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

Location

• Fully remote, preferred Cape Town thereafter Johannesburg or Durban. The candidate must be able to come to Cape Town

Benefits

• Salary range will be between 55000 and 65000 South African Rand