SACRA EXCO Nominees
2019 - 2020
We acknowledge and celebrate our current Executive Committee for their passion, dedication and hard work, demonstrated during their tenure. We thank them for their support and continued efforts to ensure that SACRA takes its place as a reputable association that advocates, educates, monitors and mentors the growing Clinical Research Industry in Southern Africa.
In terms of SACRA’s Constitution, our members are to nominate and elect an executive committee, to serve for a period of two years upon his/her election. The following nominations have been received for the SACRA 2019-2020 Executive Committee, in alphabetical order. Voting closes 9th November 2018.
Regional representatives have been separated from their industry specific sectors as some regions may have predominance of members from a single industry sector.
Please cast up to 11 votes, but no more than the individual sector/regional thresholds.
3 for Western Cape (vote threshold)
1 for Free State (vote threshold)
1 for KwaZulu-Natal (vote threshold)
CRO/Independent Sector representatives: 1 (vote threshold)
Pharma/Device Sector representatives: 2 (vote threshold)
Site Investigators/SMO Sector representatives: 3 (vote threshold)
Service Providers Category: All regional representatives
In compliance with the SACRA constitution, EXCO may co-opt additional members.
The buttons below work as quick links to each sectors’ nominee profiles.
The Voter’s Poll is placed on the 2019/2020 Election Page (Under: ABOUT SACRA)
which can only be viewed once you have logged in!
Site Investigator & SMO Representative Nominees
Dr Mohammed Tayob
Dr Tayob co-founded Mzansi Ethical Research Centre (MERC), with Dr Ayesha Bassa in 2000. In 2015 MERC-Middelburg was awarded the SCRS (Society for Clinical Research) “SPRIA” award, a global award in recognition of their TEAM’s achievements. MERC has established two other Clinical Trial sites in South Africa: MERC-Cape Town as well as MERC-Oncology (Pretoria). MERC has patnered with MeDiNova in the UK to form a Global SMO – “MeDiNova MERC UK” with sites directly owned in South Africa, United Kingdom, Spain & the USA. “MeDiNova MERC SA” has 15 affilaited sites in South Africa and still growing.
Dr Tayob has established a capacity building course – currently piloted in Mpumalanga – training public-sector healthcare professionals in clinical trials; in the process, expanding and transforming the industry. He is also part of the programme which is training healthcare professionals from Swaziland to establish a credible clinical trial industry in their country. Social projects have been the bedrock of his life, participating in many humanitarian aid missions around the world as well as a number of projects in his home town; earning him the “Paul Harris Fellowship Award” for humanitarian work – awarded by Rotary International.
He has served on many boards ranging from businesses to NGO’s including, inter alia:
Chairman of Amnesty International SA,
Board member of Agrément SA – appointed by Minister of Public Works,
Founder & Chairman: Bambanani Economic Development (BED) – Incubator for Black Healthcare Professionals.
Dr Essack Mitha
Dr Mitha qualified as a medical doctor at University of Kwa-Zulu Natal in 1998 and currently works as a full-time principal investigator in Newtown, Johannesburg. Dr Mitha has published 2 scientific letters in the South African Medical Journal. Currently working towards a Master’s degree in medical science.
Dr Mitha assisted with the setup and training of new investigators and staff in Synapta Clinical Research, in Durban. He served as a SACRA Exco member in 2008 and 2009 and assisted with increasing exposure of SACRA to investigators and sites, and drew up SOP guidelines for SACRA. Worked on Site SOPs that were work-shopped SACRA meetings. His plan is to draw up policy documents, which would assist to standardise the clinical trial industry in SA.
Major Cindi Gama
Gama Major is the co-founder of CRISMO (a clinical research investigator site management company) where he serves as the executive director responsible for the overall site management operations. He started his career working for NHLS as a laboratory assistant pre-analytics before joining Quintiles (now IQVIA) as a clinical data coordinator in Bloemfontein. He spent the last half of his six years of his career in data management at PAREXEL as clinical data analyst. In 2014 he obtained a postgraduate degree in Education while working as a contract research coordinator for several investigators and CROs around Gauteng. He’s been involved in clinical trial execution at site level for a number of years for different sponsors and study protocols, which allows him to share his experiences and lessons learned during the review, negotiation and execution of clinical trial agreement.
He was trained in management for his undergraduate qualification and completed several postgraduate studies, including short learning courses in the field of executive education training, entrepreneurship, project management and coaching. He has assumed several leadership roles as a board member, member of the management committee and currently serves on the council of the Central University of Technology, Free State representing the Alumni as a duly elected president.
Dr Vathiswa Papu-Zamxala
Dr Vathiswa Papu-Zamxala has a unique skill set and has proven to be an energetic, loyal and hard-working team player who maintains a consistently high-standard of work. Vathiswa is currently the Departmental Head of Project Management, Patient Recruitment and Feasibility at Synexus, where she leads growth expansion in Africa and develops relationships with academic hospitals and Contract Research Organisations.
Vathi holds a PhD degree from London South Bank University, in the UK and a Masters degree in Public Health fromUmea University in Sweden.In 2014, she was appointed by the Minister of Science & Technology to serve in the Board of the National Research Foundation. She is also currently serving in the Board of Sci-Bono Discovery Centre.As a woman in Science, she has been on a number of magazines, radio & tv stations, pushing science agenda in the country.
Outside work, she hosts a TV show on DSTV, channel 265, every Wednesdays at 20:00.
In 2017, she organized and spearheaded the National Symposium on Clinical Research, bringing together Government, Pharma, CRO’s, Healthcare and Academia.
CRO & Independent Representative Nominees
Elandré Kok is a driven, young career professional who is passionate about clinical research. Shortly after, quite literally, stumbling upon clinical research and regulatory affairs in 2013, he pursued postgraduate studies in those fields and currently holds a Bachelor of Science Honours degree in Pharmacology (with special focus on regulatory affairs). As of October 2015, Elandré joined Triclinium Clinical Development (TCD) and started delving into all matters related to Regulatory Affairs for clinical research. In his current role, Regulatory Affairs Associate, he supports the Head of Regulatory Affairs in the execution and coordination of all tasks associated with the regulatory aspects of clinical projects undertaken by TCD. He serves as the primary contact with the relevant statutory bodies involved in the review and approval of the various projects to which he has been assigned.
Teresa’s career began in the bio-analytical laboratory, developing assay methods for drugs in biological samples. A transition to the clinical monitoring sphere in 2001 opened another world of constant learning. Since then, Teresa has gained experience in site monitoring, GCP training, project management and medical writing. As current Clinical Operations Manager for Novotech Clinical Research, Teresa is involved in training staff and assisting sites with GCP compliance. The enjoyment of seeing the transition of an inexperienced individual into a confident researcher is what continues to motivate Teresa.
Pharma & Medical Devices Representative Nominees
Ms Nyeleti Bicky Mthombeni, Msc Project Management, UP; Msc Pharmacology, Medunsa. Current Reginal Trial Manager at Sanofi with over 10 Years industry experience, started at the National Department of Health, MCC in 2006, five years as CRA, start-up specialist and clinical project lead. She possesses the expertise, leadership, training, and motivation necessary to support the vision of SACRA. Passionate about capacity building and transformation. Contributed to the transformational idea which led to an establishment of an SMO. Strive on implementation and outcome of successful projects and learn from the ones that do not reach their success factors to improve in future. Passionate about building a professional careers with continuous learning to become one of the industry key leaders.
Samantha graduated with a BPharm from Rhodes University. Thereafter she has held several roles within the Pharma Industry from Sales Representative at Servier, Medical Information Pharmacist and Medical Liaison Manager at Bristol-Myers Squibb in the UK. On returning back to South Africa in 2004 Samantha joined GSK as a Medical Assistant but soon moved in to a CRA role. Over the next few years Samantha moved into more senior roles and eventually the Clinical Research Manager for GSK. At the end of 2013 Samantha then move to the Development Operations Senior Manager role at Amgen. Samantha has served as the chair of the IPASA Clinical Research Working Group for the last 2 years. Most recently Samantha has been the lead in establishing a new Central Monitoring function at Amgen.
Service Providers & Consultants (All Regions)
REGIONAL: Bloemfontein Representatives
Dr Michelle Middle | Service Provider & Consultant Sector
Bloemfontein, Free State
Dr Michelle Middle is currently the Chief Medical Officer for FARMOVS, the dedicated Clinical Research Organization now wholly owned by the University of the Free State. She is spearheading the expansion of clinical research at the UFS' Medical School and is responsible for planning and implementation of the FARMOVS-UFS' Strategy on "Clinical Research Capacity Building and Research Transformation".
Dr Middle, who holds a Medical degree and a Master’s degree in Pharmaceutical Medicine, has 26 years medical and research experience, spanning the full range of Phase I to IV studies and has worked in South Africa, the US and the UK. She has worked for four years as Medical Advisor and Strategic Business Executive for Synexus, the world’s largest Clinical Research Site Management Organization, and for six years for PAREXEL International, one of the top 6 CROs, where she held various international Executive Leadership positions.
Dr Middle was the founder and CEO of 3 Clinical Research companies in South Africa. She has been author and co-author of numerous articles and abstracts.
Dr Nyda Fourie | Site Investigator & SMO Sector
Bloemfontein, Free State
Dr Nyda Fourie is a medical practitioner and has been involved in a private drug and toxicology consultation service (South African Drug and Toxicology Trust) since 2001. She is a con-founder and trustee of the trust and is actively involved in the service rendering of the practice. She obtained her MB ChB (1988) and M Fam. Med (Cum Laude - 1992) from the UfS. Nyda was part of the Department of Pharmacology (Free State University) from 1994-2000, as Clinical Pharmacologist and lecturer. Nyda is co-founder and CEO of Iatros International medical research unit and is currently involved in contract research, as investigator in phase II, III and IV clinical trials.
REGIONAL: Durban Representatives
Natasha Samsunder | Service Provider & Consultant Sector
Natasha Samsunder is the Laboratory Director at CAPRISA. She has been at CAPRISA for the past 13 years. Prior to that she worked at a leading private diagnostic laboratory. She is a clinical pathology qualified Medical Technologist with a BTECH in quality. She oversees the functioning of the CAPRISA Laboratory and provides guidance and assistance to laboratories associated with CAPRISA or provides a service to CAPRISA. She has an extremely strong quality assurance focus and this ensures that all aspects of functioning are to the highest quality levels. She is a voting member of the ACTG/IMPAACT Laboratory technologist committee and serves currently as the Medical Technologist on 2 IMPAACT protocols. She also serves as a SACRA EXCO member. She has functioned as an external auditor for numerous institutions and bodies and facilitates the Good Clinical Laboratory Practices training for local and international organisations.
REGIONAL: Cape Town Representatives
Annie Gough | CRO Sector
Cape Town, Western Cape
Annie Gough has been in the industry now for twenty-three years working in a variety of roles including study coordinator, clinical research associate, clinical team manager and her current role manager of clinical operations employed by PRA Health Sciences. Her current responsibilities includes delivering various training modules and working with various teams to support ongoing quality initiatives. Annie’s background is intensive care nursing and she has worked in the respiratory ICU at Groote Schuur for 9 years. Annie currently serves as the Cape Town CRO representative on the 2017-2018 SACRA executive committee.
Gerben van den Hoogen | Site Investigator & SMO Sector
Cape Town, Western Cape
After completing his master’s degree in clinical epidemiology at the Radboud University of Nijmegen, the Netherlands, Gerben started his career in 1999 in the public health sector where he implemented policies for all stakeholders in large-scale accident and disaster management. In a combined role as policy maker and epidemiologist, he also performed research in the region to be able to establish new regional healthcare policies aligned to the population’s needs. For the past 2 years as the deputy site manager of Synexus Helderberg Clinical Research Centre, he has been responsible for the profitable management and oversight of the Helderberg site operations, oversight of the day-to-day effective running of the Helderberg site, management of study recruitment and retention, and accountable for study budgets.
During his 19-year career, he stood at the cradle (feasibilities) and the grave (archiving) of many clinical trials. With this, he has gained insight into the many aspects that make or break a study. Gerben is now passionate to apply his knowledge and skills in the drive to tip the balance in favour of ‘make’.
Sonja Oosthuizen | Pharmaceutical & Medical Device Sector
Cape Town, Western Cape
With a healthcare background as a Registered Nurse (working at the Cardiac ICU for 5 years and at Catheter and Electrophysiology labs for 4 years), I have pursued my professional career mostly in the industry in Sales and Clinical roles. Following a 2-year position as a salesperson a medical technology company, I moved to Medtronic to pursue a role as Technical Specialist and Salesperson for 4 years.
After gaining expertise in cardiovascular domain at Medtronic, I initiated the clinical study execution in South Africa as the Clinical Research Manager. I have been in the Clinical domain for the last 13 years executing the strategy and implementation of regional clinical activities as well as evidence dissemination and partnerships with Key Opinion Leaders (KOLs).
Nicky Kramer | Site Investigator & SMO Sector
Cape Town, Western Cape
Nicky Kramer is a senior pharmacist at the Clinical Research Centre (CRC) at the University of Cape Town. She has a Bachelor of Pharmacy degree from Rhodes University and a Masters of Public Health from the University of Cape Town, specialising in epidemiology and biostatistics. Nicky previously worked in the Division of Clinical Pharmacology conducting research in pharmacovigilance, and joined the CRC team in 2014. She has a passion for clinical trial pharmacy practice and chaired a Pharmacy Forum for several years aimed at teaching and collaborating with research pharmacists from sites within Cape Town. She has received training in the UK regarding IMP management, with the intention of aligning local practices to MHRA/EMA guidelines. She has a keen interest in oncology research having worked at Pfizer UK in the Oncology Business Unit as part of the scientific/medical team and in various private oncology centres in SA.
Brian Goemans | Pharmaceutical & Medical Device Sector
Cape Town, Western Cape
Brian is a Biomedical Engineer with a focus on medical device regulations and medical device development. Currently consulting to Emergo customers worldwide and South African companies on all aspects of medical device regulations, with a bias towards technical issues. Brian compiles Technical Files for CE marking, writes Clinical Evaluation Reports (CER), and compiles FDA 510(k) submissions.
Brian thrives on innovation and leading teams to develop great products - especially in the medical field. With deep experience in a variety of technologies, Brian enjoys driving projects to success with a hands-on approach.
Now consulting to various companies on:
- project management
- medical regulatory requirements
- medical product development
There is huge potential in the South African medical device industry - Brian is actively working to nurture this potential and bring South African products to the market.