What Clinical Trials Management Jobs are in South Africa?
Showing 149 Clinical Trials Management jobs in South Africa
Job Description
Our client, a prominent pharmaceutical organization, is actively seeking an experienced and detail-oriented Clinical Trial Manager to oversee critical clinical research operations in Tembisa, Gauteng . This role is integral to bringing life-changing therapies to patients by ensuring the successful execution of clinical trials according to stringent regulatory standards and internal protocols. The Clinical Trial Manager will be responsible for the planning, execution, and completion of clinical studies, managing all aspects from site selection and initiation to monitoring, data collection, and close-out. This hybrid position offers the flexibility to balance home-based work with essential on-site activities, fostering a productive and adaptable work environment. You will play a pivotal role in advancing our client's drug development pipeline.
Key Responsibilities- Develop and manage clinical trial protocols, study plans, and budgets.
- Oversee the selection, training, and management of clinical investigative sites and site staff.
- Ensure compliance with Good Clinical Practice (GCP), regulatory requirements (e.g., SAHPRA), and company SOPs.
- Monitor trial progress, identify risks, and implement mitigation strategies.
- Manage the collection, verification, and management of clinical trial data.
- Act as the primary point of contact for investigators, site personnel, and other external stakeholders.
- Coordinate with internal departments such as regulatory affairs, data management, and biostatistics.
- Prepare and present study updates to senior management and project teams.
- Ensure timely submission of study-related documents and reports.
- Lead and mentor clinical research associates (CRAs) and other study team members.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field. A Master's degree is advantageous.
- Minimum of 4 years of progressive experience in clinical trial management within the pharmaceutical industry or a CRO.
- Demonstrated knowledge of clinical trial processes, regulatory requirements (ICH-GCP, local regulations).
- Proven ability to manage multiple clinical trials simultaneously.
- Strong project management, organizational, and leadership skills.
- Excellent interpersonal, communication, and negotiation skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work effectively in a hybrid work model, demonstrating self-discipline and excellent time management.
- Willingness to travel to investigative sites as required.
- Experience in Phase II and Phase III trials is preferred.
Our client is committed to providing a rewarding employment experience, offering a competitive salary, annual bonus opportunities, comprehensive health insurance, and a retirement savings plan. Employees receive generous annual leave, sick leave, and study leave. Professional development is highly encouraged through access to industry conferences, training courses, and opportunities for career progression. The company promotes a positive and inclusive work culture. This role offers the advantage of a hybrid work arrangement, allowing for a healthy work-life balance while contributing to impactful pharmaceutical research in Tembisa, Gauteng .
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Job Description
- Develop statistical analysis plans (SAPs) for clinical trials in accordance with regulatory guidelines and study protocols.
- Perform statistical analyses of clinical trial data, including descriptive statistics, inferential statistics, and modeling.
- Interpret statistical results and provide clear, concise summaries for reports, publications, and regulatory submissions.
- Collaborate with clinical operations and data management teams to define data collection requirements and ensure data quality.
- Design study protocols and contribute to the development of Case Report Forms (CRFs) from a statistical perspective.
- Generate tables, figures, and listings (TFLs) for clinical study reports (CSRs) and other scientific documents.
- Ensure adherence to statistical programming standards and best practices.
- Stay abreast of advancements in statistical methodologies and their application in clinical research.
- Participate in the review of clinical trial protocols and other study-related documents.
- Mentor junior biostatisticians and contribute to the statistical group's expertise.
- Master's or Ph.D. degree in Statistics, Biostatistics, Mathematics, or a related quantitative field.
- Minimum of 5 years of experience as a Biostatistician in the pharmaceutical or biotechnology industry, specifically working on clinical trials.
- Proficiency in statistical analysis software such as SAS (mandatory), R, or S-Plus.
- Strong understanding of clinical trial design (e.g., adaptive designs, observational studies) and statistical methodologies.
- Experience with regulatory requirements for statistical analysis and reporting (e.g., ICH E9).
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills, essential for remote collaboration and technical reporting.
- Ability to work independently and manage multiple projects simultaneously.
- Familiarity with clinical data management processes and systems.
- A collaborative mindset and the ability to work effectively in a virtual team environment.
- Must have a reliable home office setup with high-speed internet connectivity.
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Job Description
- Develop and implement comprehensive clinical trial protocols and management plans.
- Select, train, and monitor clinical investigators and site staff to ensure compliance with protocols and GCP.
- Manage trial budgets, track expenses, and ensure timely delivery of project milestones.
- Oversee the collection, data management, and quality assurance of trial information.
- Liaise with regulatory authorities, ethics committees, and other relevant stakeholders.
- Identify and mitigate risks associated with clinical trial execution.
- Prepare clinical study reports and contribute to regulatory submissions.
- Foster strong relationships with clinical sites and external partners.
- Ensure all trial activities are conducted ethically and in accordance with international standards.
- Bachelor's degree in a life science, nursing, or related field; Master's degree or equivalent experience preferred.
- Minimum of 7 years of experience in clinical trial management within the pharmaceutical industry or a Contract Research Organization (CRO).
- In-depth knowledge of ICH-GCP guidelines, clinical trial methodologies, and regulatory requirements in South Africa and internationally.
- Proven experience in managing multiple clinical trials simultaneously.
- Excellent leadership, communication, and interpersonal skills.
- Strong organizational and project management abilities, with meticulous attention to detail.
- Proficiency in clinical trial management software and electronic data capture (EDC) systems.
- Ability to travel as required for site visits and meetings.
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Remote Biostatistician - Clinical Trials
Posted 9 days ago
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Job Description
- Design clinical trial statistical analysis plans (SAPs), including sample size calculations, endpoint definitions, and statistical methods.
- Perform statistical analyses of clinical trial data using SAS, R, or other statistical software.
- Develop and validate statistical programs for data analysis and reporting.
- Interpret statistical results and provide clear, concise summaries for clinical study reports (CSRs), regulatory submissions, and scientific publications.
- Collaborate with clinical operations, data management, and regulatory affairs teams to ensure the integrity and quality of clinical trial data.
- Contribute to the development of statistical methodologies and standards within the organization.
- Present statistical findings and methodologies to internal teams and external stakeholders, including regulatory agencies.
- Ensure all statistical activities comply with relevant guidelines (e.g., ICH E9) and company SOPs.
- Master's or Ph.D. in Biostatistics, Statistics, or a related quantitative field.
- Minimum of 5 years of experience as a Biostatistician in the pharmaceutical or biotechnology industry, focusing on clinical trial design and analysis.
- Proficiency in statistical analysis software such as SAS (required), R, or S-Plus.
- Strong knowledge of clinical trial methodology, regulatory requirements (FDA, EMA, SAHPRA), and ICH E9 guidelines.
- Experience with various statistical techniques relevant to clinical trials, including survival analysis, longitudinal data analysis, and mixed models.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to explain complex statistical concepts to non-statisticians.
- Proven ability to work independently, manage multiple projects, and meet deadlines in a remote environment.
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Job Description
- Develop and manage clinical trial protocols, budgets, and timelines.
- Oversee site selection, initiation, monitoring, and close-out activities.
- Ensure compliance with Good Clinical Practice (GCP), FDA regulations, and other applicable guidelines.
- Manage and mentor clinical research staff, including Clinical Research Associates (CRAs).
- Liaise with investigators, site staff, regulatory authorities, and internal stakeholders.
- Monitor trial progress, identify risks, and implement mitigation strategies.
- Ensure the quality and integrity of clinical trial data through effective monitoring and data management oversight.
- Manage vendor relationships, such as Contract Research Organizations (CROs).
- Prepare and present trial status reports to senior management and relevant committees.
- Contribute to the development of clinical development strategies and regulatory submissions.
- Bachelor's degree in a life science, nursing, or a related field; advanced degree preferred.
- Minimum of 5 years of experience in clinical trial management within the pharmaceutical or biotechnology industry.
- Demonstrated experience in managing multi-center clinical trials, preferably in South Africa.
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Proven leadership and team management skills, with experience managing CRAs.
- Excellent project management skills, with the ability to manage multiple priorities and deadlines.
- Strong communication, negotiation, and interpersonal skills.
- Proficiency in clinical trial management software and electronic data capture (EDC) systems.
- Ability to work effectively in a hybrid work environment, demonstrating strong self-management skills.
- A proactive approach to problem-solving and decision-making.
- Competitive remuneration package.
- Hybrid work model offering flexibility.
- Opportunities for professional growth and career advancement within a growing company.
- Comprehensive health and wellness benefits.
- Contribute to the development of innovative pharmaceutical products.
- Dynamic and collaborative work environment.
- Relocation assistance may be considered for exceptional candidates.
- Exposure to international clinical trial operations.
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Job Description
Our client, a distinguished pharmaceutical research company, is seeking a highly skilled Senior Biostatistician to enhance their clinical development team in Sandton, Gauteng . This integral role involves designing statistical analysis plans for clinical trials, performing complex statistical analyses, and interpreting results to support drug development and regulatory submissions. The Senior Biostatistician will collaborate closely with clinical operations, data management, and regulatory affairs teams to ensure the statistical integrity and validity of clinical trial data. This is a challenging and rewarding position for an experienced statistician in the pharmaceutical sector.
Key Responsibilities- Design clinical trial protocols, specifying study objectives, endpoints, sample size, and statistical methodologies.
- Develop detailed Statistical Analysis Plans (SAPs) for clinical studies.
- Perform statistical analyses of clinical trial data using SAS, R, or similar software.
- Interpret statistical results and prepare tables, figures, and listings for clinical study reports, publications, and regulatory submissions.
- Collaborate with data management to ensure data quality and integrity.
- Provide statistical expertise and guidance to cross-functional study teams.
- Stay current with statistical methodologies, regulatory guidelines (e.g., ICH E9), and software advancements.
- Contribute to the development of statistical programming standards and best practices.
- Mentor junior biostatisticians and statistical programmers.
- Present statistical findings and rationale to internal stakeholders and regulatory agencies.
- Master's or Ph.D. in Statistics, Biostatistics, or a related quantitative field.
- Minimum of 5 years of experience in biostatistics, with a strong focus on clinical trial analysis within the pharmaceutical or biotechnology industry.
- Proficiency in statistical software such as SAS (highly preferred), R, or S-Plus.
- In-depth knowledge of statistical methodologies commonly used in clinical trials (e.g., survival analysis, longitudinal data analysis, mixed models).
- Understanding of clinical trial design and regulatory requirements for drug development.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to explain complex statistical concepts to non-statisticians.
- Experience with data standards (e.g., CDISC) is highly desirable.
- Ability to manage multiple projects and work effectively in a fast-paced environment.
Our client offers a highly competitive salary, comprehensive benefits including medical, pension, and performance bonuses. Opportunities for professional development, attendance at scientific conferences, and career advancement are readily available. This role is based in the vibrant business hub of Sandton, Gauteng , offering a stimulating and collaborative work environment.
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Remote Clinical Trial Coordinator
Posted 6 days ago
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Job Description
- Assist Principal Investigators (PIs) and clinical research staff in conducting clinical trials according to protocol.
- Manage and maintain accurate and complete trial documentation, including source documents and case report forms (CRFs).
- Coordinate patient recruitment, screening, scheduling of visits, and study procedures.
- Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and study protocols.
- Assist with data entry and query resolution in clinical databases.
- Prepare for and participate in site initiation visits, monitoring visits, and close-out visits.
- Communicate effectively with study sites, sponsors, and internal team members.
- Maintain study supplies and equipment.
- Support the timely completion of study milestones.
- Associate's degree or Bachelor's degree in a healthcare-related field or equivalent experience.
- Minimum of 2 years of experience in clinical research coordination or as a clinical research assistant.
- Solid understanding of clinical trial phases, terminology, and processes.
- Familiarity with Good Clinical Practice (GCP) guidelines and regulatory requirements.
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS) is a plus.
- Excellent organizational and time management skills.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a remote team.
- Detail-oriented with a commitment to accuracy and quality.
- Competitive salary and performance-based incentives.
- Fully remote position with flexible working hours.
- Comprehensive health, dental, and vision insurance.
- Paid time off and company holidays.
- Opportunities for professional development and certification in clinical research.
- A collaborative and supportive team culture focused on patient well-being.
- The chance to contribute to groundbreaking medical research from the comfort of your home.
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Job Description
*** _Please note: due to sponsor requirements for the role only candidates based in the listed location/s and with previous Global CTM experience will be considered. Any applications from candidates based outside of these locations will not be considered._
**Job Overview**
Clinical Trial Managers (CTM) are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' lives by bringing new drugs to the market faster. The CTM is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies to meet contractual requirements and in accordance with (Standard Operating Procedures) SOPs, policies and practices.
**Essential Functions**
- Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
- Accountable for meeting projects' recruitment targets and ensuring appropriate recruitment strategies are in place.
- Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle.
- Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
- Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
- Work as the primary CTM alongside other CTMs to deliver large, global trials.
- Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
- Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
- Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
- Conduct regular team meetings and communicate appropriately to achieve objectives.
- Support professional development by providing feedback to clinical team line managers on performance relative to project tasks to support professional development.
- Adopt corporate initiatives and changes and serve as a change advocate when necessary.
- May contribute to the development of the clinical delivery strategy for business proposals. Participate in bid defense preparations and meetings. Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership.
- May mentor and coach new peers as they assimilate into this role.
- May attend site visits as applicable in support of project delivery.
**Qualifications**
- Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required
**Experience**
- Ideally at least 5 years experience in clinical trial management or equivalent combination of education, training and experience.
- Requires consolidated knowledge of Project management practices and terminology.
- Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Requires broad protocol knowledge and therapeutic knowledge.; Req
- Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.
- Requires understanding of project finances.
- Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements
i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.;
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
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