41 Clinical Documentation jobs in South Africa

My client, a growing CRO is seeking a CDM (Clinical Data Manager) to be based in Bloemfontein.

Excellent salary and growth opportunities

The Clinical Data Manager (CDM) is responsible for maintaining and constantly improving the CRO’s performance and quality in data management services. This includes but is not limited to the following activities: Database set-up, maintenance and close-out activities for EDC and paper studies and development of data management-relevant study documents. Responsibilities also include supporting other (data management) team members, project management activities and communication with customers as well as process improvement.

Overview ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. Position overview: We have an exciting opportunity for an analytically minded individual to join our Data Analytics department as a Clinical Data Visualization Expert, which is part of an existing global team, dedicated to a specific key client account. As part of this team of 40+ Programming Analyst & Visualization Developers, you will deliver a range of visualization dashboards utilising clinical data. Alongside exposure to one of the world's leading pharma businesses, the successful candidate will also have peace of mind that they are on a proven progression path, within the largest global provider of embedded clinical research solutions. Responsibilities Your role will include the following:- Collaborating closely with key business stakeholders to analyse their requirements Delivering metrics and reporting tools Using your strong programming skills to create interactive dashboards and data visualizations Providing consultative industry leading solutions to our client Working on multiple cross functional projects with a large, diverse operational analytics team Qualifications You are: A solutions orientated, analytical and customer focused individual with a strong focus on operational excellence. Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have: Experience with visualization tools such as Spotfire, Tableau, Qlik, IBM Cognos (or similar tools), gained in a commercial setting Expert level knowledge of clinical data standards, in particular CDISC SDTM, gained in a clinical trials role Experience with Object Oriented Programming languages, preferably Python Ability to work analytically in a problem solving environment A Bachelor’s degree in Life Sciences, Mathematics, Computer Science Excellent written and verbal communication skills, in particular when communicating independently with stakeholders Fluency in English Excellent attention to detail A drive to learn and master new technologies and techniques What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. #J-18808-Ljbffr

Clinical Data Risk Analyst - Bulgaria, Sofia Hybrid: Office/Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. What you will be doing The responsibilities of the Data Scientist include, but are not limited to: Identify data sources and propose data preparation approaches, e.g., using raw data sets as input Identify, select, and possibly combine key variables Prepare datasets based on specifications Set up and refresh Cluepoints reports (KRI, DQA) regularly according to study specifics Run additional analyses with B&P/TO teams to understand findings if appropriate Interpret findings to help RBM central monitors understand signals Prepare reports summarizing results, data findings, and signals Support the definition of actions to adapt RBM strategies to signals Collaborate closely with RBM Central Monitors Follow RBM processes for global and local teams Mentor new RBM Data Scientists Experience & Skills Systems: SAS EG, Rave, Cluepoint, Anaconda3 Skills: Cluepoint: Experience with Cluepoint is highly valuable. Understanding of Clue Point's smart engine, testing for KRI sensitivity, and familiarity with KRI & DQA dashboards setup and refresh process. SAS: Develop programs based on reference code and KRI specifications from scratch. Python: Update parameters, execute, debug, and perform minor or major updates to programs. Translate natural language specifications into programming code for KRI. What ICON can offer you Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including: Annual leave entitlements Health insurance options Retirement planning options Global Employee Assistance Programme through TELUS Health Life assurance Optional benefits like childcare vouchers, bike schemes, gym discounts, travel passes, health assessments, etc. Visit our careers site to learn more about our benefits. ICON values inclusion and belonging, providing an accessible environment for all candidates. We are committed to equal employment opportunities and a workplace free of discrimination and harassment. If you require reasonable accommodations during the application process or to perform job functions, please let us know or submit a request here . Interested but unsure if you meet all requirements? We encourage you to apply — you might be exactly the candidate we're seeking. If you are a current ICON employee, please click here to apply. #J-18808-Ljbffr

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. Position overview: We have an exciting opportunity for an analytically minded individual to join our Data Analytics department as a Clinical Data Visualization Expert, which is part of an existing global team, dedicated to a specific key client account. As part of this team of 40+ Programming Analyst & Visualization Developers, you will deliver a range of v isualization dashboards utilising clinical data. Alongside exposure to one of the world's leading pharma businesses, the successful candidate will also have peace of mind that they are on a proven progression path, within the largest global provider of embedded clinical research solutions. Your role will include the following:- Collaborating closely with key business stakeholders to analyse their requirements Delivering metrics and reporting tools Using your strong programming skills to create interactive dashboards and data visualizations Providing consultative industry leading solutions to our client Working on multiple cross functional projects with a large, diverse operational analytics team You are: A solutions orientated, analytical and customer focused individual with a strong focus on operational excellence. Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have: Experience with visualization tools such as Spotfire, Tableau, Qlik, IBM Cognos (or similar tools), gained in a commercial setting Expert level knowledge of clinical data standards, in particular CDISC SDTM, gained in a clinical trials role Experience with Object Oriented Programming languages, preferably Python Ability to work analytically in a problem solving environment A Bachelor’s degree in Life Sciences, Mathematics, Computer Science Excellent written and verbal communication skills, in particular when communicating independently with stakeholders Fluency in English Excellent attention to detail A drive to learn and master new technologies and techniques What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. #J-18808-Ljbffr

As a Rave Database Developer, you will join the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.

What you will be doing:

• Develop and maintain data management documentation and guidelines in accordance with Good Clinical Practices (GCP) and Good Documentation Practices (GDP).
• Provide subject matter expertise to project team members during all phases of the project lifecycle.
• Develop, test, and maintain data management systems.
• Assist during internal and external audits and inspections with your expertise.
• Collaborate with Data Managers, Study Teams, Vendors, and Site Staff to formulate Data Transfer plans for secondary data sources (e.g., Lab data, Site data).
• Batch import agreed data sources into the EDC system.
• Develop, program, validate, and maintain Medidata Rave EDC clinical trial databases according to company standards.
• Create EDC design specifications including data dictionary, event definitions, electronic consent, branching logic, edit checks, query rules, calculated fields, and dynamic forms.
• Design and construct the EDC database based on global eCRF libraries in collaboration with Data Managers and study teams.
• Configure and optimize patient interfaces for various data collection modes (eCOA on mobile devices or tablets, EDC on laptops/desktops).
• Conduct, test, and produce activities related to Rave EDC Migration.
• Develop test scripts and coordinate user acceptance testing (UAT) to ensure database accuracy.
• Manage deployment of new or updated EDC databases into production.
• Assist in mapping the EDC database to the enterprise data warehouse.
• Develop and implement standards to improve quality and streamline database build processes.
• Be available to work on any BSC studies.
• Follow BSC SOPs/WIs.

You are:

• Possessing 5+ years of experience in development.
• Metadata Rave certified (REQUIRED).
• Holding a BS Degree.
• Medidata Rave EDC Certified Study Builder.
• This is a hybrid position requiring 3 days on-site and 2 days remote in Marlborough, MA.

Candidates must be certified and have either:

• Medidata Rave EDC Certified Study Builder, or
• At least the equivalent experience with Medidata Rave Study Design and Build Essentials (SDBE).

Pay Range: $75,809 - $94,550 USD per year. Actual compensation depends on location, experience, education, and skills.

What ICON offers:

We prioritize a diverse culture that rewards high performance and nurtures talent. Besides a competitive salary, we offer benefits focused on well-being and work-life balance, including:

• Various annual leave entitlements
• Health insurance options
• Retirement planning
• Global Employee Assistance Programme
• Life assurance
• Optional benefits like childcare vouchers, gym memberships, and more

Learn more at:

ICON values inclusion & belonging. We are committed to an accessible environment and equal opportunity employment. If you need accommodations during the application process, please let us know through this form .

If you're interested but unsure if you meet all requirements, we encourage you to apply. You might be exactly what we're looking for!

#J-18808-Ljbffr

The Clinical Data Manager (CDM) will perform scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).

Deliverables:

1. Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
2. Provides scientific data review support for more than one low to moderate complexity trial or one high complexity trial.
3. The data management expert, within the therapeutic area, performs scientific (complex) clinical data review in close collaboration with SRP and SRS, leveraging technical and clinical expertise. Collaborates with SRP, SRS, Data Management, and other study team members to implement data management activities, focusing on complex indication and therapy-related elements. Reviews data flows, Data Management Plans, and performs continuous complex data review activities.
4. Involved in study activities from protocol design, providing input into data collection tools.
5. Reviews scientific study data, manages CDM and SRS/SRP queries in eDC system, and discusses findings with SRS/SRP. May be involved in coding and SAE reconciliation. Leads or attends meetings as appropriate.
6. Leads collaboration with SRP/SRS and GDM to establish and confirm scientific clinical data review expectations for assigned trials.
7. With trial stakeholders, reviews eCRF content, establishes data conventions and quality expectations, and sets timelines for CDM milestones.
8. Creates the Integrated Review Plan, ensuring quality, scientific content, clarity, accuracy, and regulatory compliance. Reviews related documents.
9. Ensures inspection readiness of all deliverables; participates in inspections and audits as necessary.
10. Plans, tracks, and ensures timely delivery of CDM activities.
11. Collaborates with SRS/SRP to meet trial needs and deliverables.
12. Identifies lessons learned, best practices, and FAQs at the trial level.
13. Participates in process, system, and tool improvement initiatives within clinical data management.

Therapeutic Area: Oncology, Cardiovascular, and Immunology

Education/Experience:

• BS/BA degree or higher in Health Sciences or related field, or equivalent professional clinical experience.
• At least 5 years of Data Management experience, preferably including clinical data review and knowledge of medical terminology.
• Experience collaborating with clinical teams.

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 to accelerate the development and commercialization of medical treatments to improve patient outcomes and population health worldwide. Learn more at .

#J-18808-Ljbffr

Program Manager, Clinical Data Science - South Africa or Poland

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Program Manager, Clinical Data Science to join our diverse and dynamic team. As a Program Manager in Clinical Data Science at ICON, you will play a crucial role in overseeing and coordinating data science initiatives within clinical programs. You will lead cross-functional teams to ensure the successful execution of data-driven projects, from data collection and analysis to the implementation of insights that drive clinical outcomes and operational efficiencies.

What You Will Be Doing:

• Managing the end-to-end execution of clinical data science programs, including planning, resource allocation, and delivery of data science projects within scope, time, and budget constraints.
• Coordinating with data scientists, statisticians, clinical researchers, and other stakeholders to ensure alignment on project objectives, data requirements, and analytical approaches.
• Developing and maintaining program plans, timelines, and budgets, and monitoring progress to ensure timely and successful completion of data science initiatives.
• Providing strategic oversight and guidance on data science methodologies, ensuring that analyses are rigorous, valid, and aligned with clinical and regulatory standards.
• Communicating program status, insights, and outcomes to stakeholders, including executive leadership, and addressing any issues or risks that may impact program success.

Your Profile:

• Bachelor’s degree in data science, statistics, clinical research, or a related field. Advanced degree and/or relevant certifications are preferred. Extensive experience in program management within the clinical data science or related domain.
• Strong background in data science methodologies, statistical analysis, and clinical research, with a track record of successfully managing complex data-driven projects.
• Exceptional leadership skills with experience managing cross-functional teams and collaborating with various departments to achieve program objectives.
• Proficiency in project management tools and techniques, with experience in risk management, budgeting, and resource planning.
• Excellent communication and interpersonal skills, with the ability to convey complex data insights clearly and build effective relationships with stakeholders at all levels.

#LI-SA1

#REMOTEPOLAND

#REMOTESOUTHAFRICA

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

#J-18808-Ljbffr

Program Manager, Clinical Data Science - South Africa or Poland

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Program Manager, Clinical Data Science to join our diverse and dynamic team. As a Program Manager in Clinical Data Science at ICON, you will play a crucial role in overseeing and coordinating data science initiatives within clinical programs. You will lead cross-functional teams to ensure the successful execution of data-driven projects, from data collection and analysis to the implementation of insights that drive clinical outcomes and operational efficiencies.

What You Will Be Doing:

• Managing the end-to-end execution of clinical data science programs, including planning, resource allocation, and delivery of data science projects within scope, time, and budget constraints.
• Coordinating with data scientists, statisticians, clinical researchers, and other stakeholders to ensure alignment on project objectives, data requirements, and analytical approaches.
• Developing and maintaining program plans, timelines, and budgets, and monitoring progress to ensure timely and successful completion of data science initiatives.
• Providing strategic oversight and guidance on data science methodologies, ensuring that analyses are rigorous, valid, and aligned with clinical and regulatory standards.
• Communicating program status, insights, and outcomes to stakeholders, including executive leadership, and addressing any issues or risks that may impact program success.

Your Profile:

• Bachelor’s degree in data science, statistics, clinical research, or a related field. Advanced degree and/or relevant certifications are preferred. Extensive experience in program management within the clinical data science or related domain.
• Strong background in data science methodologies, statistical analysis, and clinical research, with a track record of successfully managing complex data-driven projects.
• Exceptional leadership skills with experience managing cross-functional teams and collaborating with various departments to achieve program objectives.
• Proficiency in project management tools and techniques, with experience in risk management, budgeting, and resource planning.
• Excellent communication and interpersonal skills, with the ability to convey complex data insights clearly and build effective relationships with stakeholders at all levels.

#LI-SA1

#REMOTEPOLAND

#REMOTESOUTHAFRICA

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family’s needs.

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here .

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

#J-18808-Ljbffr

Perform comprehensive data management tasks including data review, query generation and query resolution. This may also include, but is not limited to creation of eCRF completion guidelines, entry of test data for eCRF and the Data Review Model, testing of data validation rules, etc. Data Management tasks should be inclusive of Study Start-up, Execution, Database Lock and Close-out.

Responsibilities:

• Perform ongoing Data Reconciliation of all data streams
• Attend study related meetings/teleconferences
• Perform Study Closeout/Archiving Activities including QC of subject/site archival CRFs
• Create and provide status/metric reports
• Generate reports on EDC and track cleaning progress
• Manage Freeze / lock of eCRF
• File documentation in the virtual Trial Master File (TMF)
• Receives and enters lab normal ranges

Advanced Responsibilities:

• Provide timely status updates including issues & risks to GDM and DMLs as needed
• Act as the Point of contact for Global Data Manager/Clinical Data Manager, working pro-actively to identify risks and provide mitigations
• May communicate with the vendors to resolve reconciliation issues.
• Provide input to Study set up activities including but not limited to creation of DVRs
• Create and/or provide inputs to Data Management documents (e.g. eCRF completion guidelines, etc.).
• Review and provide inputs to Data Management documents (e.g. IRP, DMP, etc.)
• Assign work to allocated CDAs on a trial. Coordinate work of CDAs assigned to a study working closely with the Global Data Manager to understand priorities and timelines.
• Assist the Data Management Leader in TMF compliance reviews.
• Train and mentor CDA staff

Education and Experience Guidelines:

• Bachelor’s degree in a Health or Science discipline with experience in clinical research.
• Data Management experience and experience working on a clinical trial mandatory.
• Experience working in highly diverse teams within clinical research; cross-functional, global, multi-regional.
• Knowledge of current industry standards (e.g., CDISC, SDTM, CDASH, etc.) for Advanced CDA.
• Knowledge of technology platforms and systems to capture and process data
• Project management skills.
• Vendor management skills.
• Proficiency with Microsoft Office tool
• Highly organized with excellent written and verbal communication.
• Ability to interpret clinical trial data and present trends to clinical trial team on data.

Experience CDA BASE level: 1-3 years of experience.

Experience CDA ADVANCED level: >3 year of experience

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 IQVIA Careers

#J-18808-Ljbffr