Clinical Trial Manager SA

South Africa: Cape Town or Johannesburg
[Closing date: 15 April
 2018]                                                                 

 

The Drugs for Neglected Diseases initiative (DNDi), established in 2003 in Geneva, Switzerland, is a collaborative, patient-needs driven, non-profit drug research and development (R&D) organization that seeks to improve the quality of life and the health of people suffering from neglected diseases by using an alternative model to develop drugs for these diseases and by ensuring equitable access to new and field-relevant health tools.

DNDi is now working across 10 offices (Geneva, Rio, Kinshasa, Nairobi, New Delhi and Patna (India), Kuala-Lumpur (Malaysia), New York, Tokyo and most recently Cape Town) employing ~200 full time equivalent core staff and operating through a virtual business model with many partners, suppliers and consultants. As part of its mission, DNDi advocates for increased public responsibility and a more enabling environment for neglected disease R&D at a global, regional and national level.

Since 2014, DNDi has initiated activities in South Africa, mainly with its currently ongoing Paediatric HIV programme and the extension of the ongoing HCV programme with clinical studies starting in South Africa in 2018.  A Memorandum of Understanding was signed in 2014 with the South African Department of Health for the Paediatric HIV programme. 

More recently, WHO and DNDi have collaborated on the creation of a Global Antibiotic Research and Development Partnership, to develop new antibiotic treatments addressing antimicrobial resistance. DNDi has agreed to facilitate the set up and hosting of the partnership and provide the scientific environment, necessary personnel and infrastructure to ensure an effective incubation period. GARDP as such is part of the DNDi institutional framework for the incubation period.

GARDP signed a Memorandum of Understanding in 2016 with the South African Medical Research Council to establish the basis for close collaboration both institutionally and on specific projects including on drug development for neonates, sexually transmitted diseases, and drug discovery. GARDP launched two projects in 2017 and anticipate two additional projects in 2018, with drug discovery and substantial clinical activity in South Africa.

DNDi, and in particular the GARDP and the HIV/HCV programmes, aims to strengthen its presence in South Africa, and has established a Liaison office in Cape Town, hosted initially within the South African Medical Research Council, to support the R&D activities, manage the relationships with academia, pharmaceutical companies, and government agencies.

 

Purpose of the position

GARDP – STI Programme

Gonorrhea is one of the most common Sexually Transmitted Infections (STIs), affecting 78 million people every year. The Western Pacific and African regions have the highest incidence of gonorrhea, with 89 and 50 cases per 100’000 population respectively. In the USA it causes 400’000 infections per year and is the second most frequently reported notifiable infectious diseases. There are serious concerns, articulated by the WHO and others, over the spread of resistant gonorrhea. Neisseria gonorrhoeae, the causative agent of gonorrhea, has been included as one of three organisms presenting an urgent threat by the US Center for Disease Control (US CDC) and is listed as a “high priority” pathogen in the WHO Global priority list of antibiotic-resistant bacteria.

Single dose antimicrobial monotherapy has been the mainstay of gonococcal infections management for long. Currently, the WHO-recommended first-line treatment for gonorrhea is Ceftriaxone + Azithromycin. However, resistance to Ceftriaxone and Azithromycin have started to emerge globally, and new treatments that tackle Multi-Drug Resistant (MDR) gonorrhea are urgently needed. To address the rising concern of drug-resistant gonorrhea GARDP has partnered with Entasis Therapeutics to develop and register zoliflodacin, a new chemical entity with high activity against Neisseria gonorrhoeae. Zoliflodacin is a first-in-class drug (spiropyrimidinetrione) that inhibits bacterial topoisomerase II and shows in vitro antibacterial activity against several STI pathogens. To date, three clinical trials have been completed: a phase I Single-Ascending Dose (SAD) trial, a phase I Absorption, Distribution, Metabolism, Excretion (ADME) trial and a phase II study involving patients with confirmed uro-genital gonococcal infection.

GARDP – Neonatal Sepsis Programme

Despite progress on child mortality, neonatal mortality remains unacceptably high. Nosocomial infections are the leading cause of mortality and morbidity in the neonatal intensive care unit (NICU), affecting from 7% to 24% of admitted patients. In all hospital settings, especially NICUs, the increase of infections caused by Multi Drug Resistant Gram-Negative Bacteria resistant to antibiotics (including carbapenems) represents a serious threat, especially for critically ill neonates who are at high risk due to the immaturity of their immune systems.

The current WHO recommended empiric treatment for possible serious bacterial infections (pSBI) for neonates (<28days) in a hospital setting is ampicillin (amoxicillin) plus gentamicin. When referral is not possible then, once daily gentamicin plus oral amoxicillin may be used.  However, there is an increasing incidence of resistance to this first line treatment.  Furthermore, in some low and middle income countries including India and South Africa multi-drug resistant (MDR) organisms such as extended spectrum β-lactamase (ESBL)-producing Enterobacteriaceae have been reported including E coli and Klebsiella spp and in some cases, extensively drug resistant (XDR) Gram-negative bacteria such as Carbapenem resistant enterobacteriacae(CRE) have been reported in the neonatal paediatric intensive care units. These represent a major challenge in management of neonatal sepsis.  The NeoAMR project aims to combine investigations into the safety, effectiveness and microbiological impact of off-patent antibiotics and antibiotics that are identified from AMRi programme and evaluate them in a so far understudied neonatal population.

The CTM plays an important role in the development of new drugs and treatments that address Anti- Microbial Resistance (AMR). S/he supports activities for GARDP projects on neonatal sepsis and sexually transmitted infections. This includes but is not limited to coordination of a regional observational study and clinical trial activities. The post is based in South Africa (Johannesburg or Cape Town) with frequent domestic travel and occasional travels to Europe.

 

Specific job responsibilities

Project management

  • Support the GARDP/DNDi Project Team in developing project schedules and budget for South Africa
  • Support the GARDP/DNDi Project Team in managing local sub-contractors (e.g. safety laboratories)
  • Monitor milestones and expenses for project evaluation with the Project Team
  • Collect data and information to enable the Project Leader and Head of South Africa Regional 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
  • Compile and write a monthly and yearly project update as required
  • Under supervision of the Project leader, be able to represent GARDP/DNDi to the relevant medical authorities (Department of Health and National Regulatory Authorities) as and when needed
  • Under supervision of the Project Leader, be able to represent DNDi in both scientific and communication events as and when needed

Coordination of the clinical trials conducted by DNDi

  • Conduct trial feasibility assessment and support the Project Team in identifying suitable study sites
  • Arrange trial specific and applicable training for trial site teams and identify training needs for collaborative sites
  • Coordinate with Project Team and external vendors for planning, conduct and monitoring of all trial-related activities (e.g. data management, monitoring, logistics, etc…)
  • Upon request, provide backup, support, and advice/mentorship for trial monitors including co-monitoring and substitute monitoring as and when required
  • Review monitoring reports, and assist in resolving issues identified during the monitoring visits
  • Ensure trial sites comply with trial safety reporting procedures e.g. Serious Adverse Events (SAE) reporting and facilitate communication between sites and GARDP/DNDi PV team
  • Liaise with Finance & Administration for trial related activities and payments
  • Support and respond to requests from trial site team members and PIs on trial related matters
  • Prepare monthly and annual reports
  • Assist in organizing Investigator Meetings

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
  • Lead the preparation and submission of clinical trial applications dossiers to regulatory authorities
  • Support Investigators in preparing clinical trial applications dossiers for ethics review
  • Prepare and review clinical SOPs and other standard documents required for clinical trials
  • Contribute to the set up and to review of DNDi systems related to clinical operations as appropriate

Personal

  • Develop and maintain the skills required for delivery of all aspects of clinical trials
  • Maintain an awareness of all developments in the designated disease areas that relate to drug development and access
  • Be aware of developments in clinical development and the regulatory environment, and report these to GARDP

 

Job requirements

Skills and attributes

  • Demonstrable (virtual) team-working skills as well as ability to work independently
  • Strong 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
  • Excellent communication and interpersonal skills
  • Strong ability to interact with internal and external stakeholders
  • Has autonomy for taking actions and decisions
  • Strong ability to interact with external stakeholders
  • Strategic thinking and leadership abilities

R&D technical skills

  • Knowledge of GCP and South Africa regulatory requirements for clinical trials
  • Knowledge and experience of electronic Data Capture Systems (eDCS) is a plus
  • Project Management skills desirable is a plus

Experience

  • Minimum 5 years of relevant experience
  • Advanced experience in monitoring clinical trials
  • Experience and affinity with training and coaching
  • Proven ability to work effectively in a team environment and matrix structure
  • Clinical experience and understanding of global issues related to antimicrobial chemotherapy is desirable
  • Experience of working in public and private sector is highly desirable

Education

  • Degree in health-care related discipline

Other requirements

  • Fluency in written and verbal English
  • Position based in South Africa
  • Ability to do frequent domestic travel and occasional travels to Europe (Asia, EU and the US)

 

Reporting line

  • S/he has double reporting line to the Head of the South African Regional Office and to the Trial Manager of the respective GARDP programme

 

Other information

  • Status: full time – 2 years fixed term contract

 

To apply

  • Deadline for application: Accepting applications until 15 April 2018
  • Only shortlisted candidates will be contacted.