Job Vacancies at PAREXEL

About the Role

• We are seeking a Clinical Data Associate II to join our team in South Africa in a remote capacity.
• As a Clinical Data Associate II, you will support global clinical research programs by delivering high-quality data management activities across Phase I-IV clinical studies. This position plays a key role in clinical data quality, regulatory compliance, study execution, and cross-functional collaboration.
• You will partner with clinical teams, statisticians, programmers, CRAs, vendors, and study management teams to ensure accurate and timely data collection, review, reconciliation, and database management activities. Responsibilities include supporting and leading data management activities, coordinating Electronic Data Capture (EDC) systems, developing study documentation, and contributing to database lock and study deliverables.
• You will join a fast-paced, growth-oriented environment dedicated to a single sponsor and supporting important commercial and development programs worldwide.
• This role offers the opportunity to contribute directly to clinical research that advances new therapies while expanding your expertise across data management processes, clinical technologies, and cross-functional study operations.

Key Responsibilities

• Lead a small clinical study or co-lead larger studies with moderate guidance.
• Support multiple clinical studies while ensuring high standards of data quality and delivery.
• Manage and monitor data management activities performed by CROs and external vendors.
• Review study protocols and evaluate data capture requirements, including electronic Case Report Form (eCRF) design.
• Collaborate with CRAs, programmers, study managers, and statisticians to develop annotated eCRFs and CRF completion guidelines.
• Develop data edit check specifications and generate study data listings as required.
• Coordinate the design, testing, and issue resolution of Electronic Data Capture systems in accordance with company standards.
• Develop and maintain study Data Management Plans and supporting documentation
• Perform query management, external data reconciliations, and Serious Adverse Event reconciliation activities.
• Support database upgrades, migrations, user acceptance testing, database freeze activities, and database lock activities.
• Maintain study workbooks and data management files while ensuring inspection readiness.
• Contribute to the development and improvement of data management SOPs, work instructions, and process documentation.

Candidate Profile

You'll thrive in this role if you bring:

• Strong attention to detail, analytical thinking, and organizational skills.
• Experience working within clinical research and regulated pharmaceutical or biotechnology environments.
• The ability to collaborate effectively across multidisciplinary teams as well as with external partners and vendors.
• A patient-focused mindset with a commitment to data quality and regulatory compliance.
• Comfort working with Electronic Data Capture systems, clinical databases, and multiple technology platforms.

Required Qualifications

• Bachelor's Degree in a scientific or healthcare-related field.
• At least two years' experience in Data Management within the pharmaceutical or biotechnology industry.
• Understanding of Phase I-IV clinical studies and demonstrated ability to perform core Data Management activities and work with vendors.
• Knowledge of ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, and related industry standards.
• Experience with Electronic Data Capture systems and clinical data management technologies. RAVE experience is strongly preferred.
• Strong communication, organization, technical, and problem-solving skills.

Preferred Qualifications

• Experience in Oncology or CNS therapeutic areas.
• Experience supporting Phase III pivotal studies.

Benefits and Compensation

• Medical Aid Contribution
• Gap Cover
• Life Assurance
• Provident Fund (8%)
• 13th Cheque

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About the Role

• We are seeking a Senior Clinical Data Associate to join our team in South Africa in a remote capacity.
• As a Senior Clinical Data Associate, you will support global clinical research programs by delivering high-quality data management activities across Phase I-IV clinical studies. This position plays a key role in clinical data quality, regulatory compliance, study execution, and cross-functional collaboration.
• You will partner with clinical teams, statisticians, programmers, CRAs, vendors, and study management teams to ensure accurate and timely data collection, review, reconciliation, and database management activities. Responsibilities include supporting and leading data management activities, coordinating Electronic Data Capture (EDC) systems, developing study documentation, and contributing to database lock and study deliverables.
• You will join a fast-paced, growth-oriented environment dedicated to a single sponsor and supporting important commercial and development programs worldwide. This role offers the opportunity to contribute directly to clinical research that advances new therapies while expanding your expertise across data management processes, clinical technologies, and cross-functional study operations.

Key Responsibilities

• Lead a small clinical study or co-lead larger studies with moderate guidance.
• Support multiple clinical studies while ensuring high standards of data quality and delivery.
• Manage and monitor data management activities performed by CROs and external vendors.
• Review study protocols and evaluate data capture requirements, including electronic Case Report Form (eCRF) design.
• Collaborate with CRAs, programmers, study managers, and statisticians to develop annotated eCRFs and CRF completion guidelines.
• Develop data edit check specifications and generate study data listings as required.
• Coordinate the design, testing, and issue resolution of Electronic Data Capture systems in accordance with company standards.
• Develop and maintain study Data Management Plans and supporting documentation
• Perform query management, external data reconciliations, and Serious Adverse Event reconciliation activities.
• Support database upgrades, migrations, user acceptance testing, database freeze activities, and database lock activities.
• Maintain study workbooks and data management files while ensuring inspection readiness.
• Contribute to the development and improvement of data management SOPs, work instructions, and process documentation.

Candidate Profile

You'll thrive in this role if you bring:

• Strong attention to detail, analytical thinking, and organizational skills.
• Experience working within clinical research and regulated pharmaceutical or biotechnology environments.
• The ability to collaborate effectively across multidisciplinary teams as well as with external partners and vendors.
• A patient-focused mindset with a commitment to data quality and regulatory compliance.
• Comfort working with Electronic Data Capture systems, clinical databases, and multiple technology platforms.

Required Qualifications

• Bachelor's Degree in a scientific or healthcare-related field.
• At least five years' experience in Data Management within the pharmaceutical or biotechnology industry.
• Understanding of Phase I-IV clinical studies and demonstrated ability to perform core Data Management activities and work with vendors.
• Knowledge of ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, and related industry standards.
• Experience with Electronic Data Capture systems and clinical data management technologies. RAVE experience is strongly preferred.
• Strong communication, organization, technical, and problem-solving skills.

Preferred Qualifications

• Experience in Oncology or CNS therapeutic areas.
• Experience supporting Phase III pivotal studies.

Benefits and Compensation

• Medical Aid Contribution
• Gap Cover
• Life Assurance
• Provident Fund (8%)
• 13th Cheque

go to method of application »

About this Role

• The (Senior) Feasibility & Strategy Leader (FSL / sFSL) acts as a key contributor to the proposal team to support Parexel in winning new business. Working independently, the FSL is responsible for delivering, in collaboration with Integrated Solutions Director and Patient Recruitment Strategy (PRS), an optimized patient-focused, risk informed strategic solution that delivers the right countries, right sites, and right patients and is operationally deliverable. This therapy aligned role supports all types and phases of study pursuits, including programs.
• The person in this role must demonstrate excellent communication ability, strategic thinking, independent decision-making competency and have a track record working in a fast-paced, time pressured environment. Strong analytical and persuasive, client-focused writing skills are a pre-requisite to the job to allow the FSL to fully adopt a consistent data-driven approach to feasibility and deliver clear, concise, selling proposal messages both in text and in client meetings.

Key Accountabilities:

• Strategic collaboration with the virtual RFP team: Take active role in creating and presenting integrated strategy for strategic scenario planning for each study or program. Through in-depth review of the RFP documents and collaboration with key stakeholders, ensure a full understanding of customer requirements for the proposal as well as key drivers for CRO selection decision.
• Risk-informed recruitment benchmark data analysis: Create the basic foundations for the enrolment scenario building, namely range of countries and sites as well as months of recruitment required to enroll the target patients including efficiencies across studies and programs. Identify potential challenges/risks associated with Sponsor specifications if any.
• Patient-focused approach to feasibility recommendations: Determine where these patients are found in the healthcare section, recognizing the global nature of the study. Identify site and patient barriers and motivators to participate in this study. This should be discussed with the study assigned MD for confirmation or questions and leveraging available data sources such as RWD or data generated in collaboration with the patient insights team
• Determine and operationalize relevant pre-award feasibility activities: Evaluate and deploy fit-for-purpose activities to support and/or back-up Parexel strategic delivery plan to conduct the trial in order to positively influence Sponsor award decision. For mega studies or partnership programs, this may include leading pilots for innovative feasibility approaches and/or leading feasibility team to deliver multiple services in parallel.
• Conduct country analysis and develop risk-based recommendations: Use available country selection tool/platform and deliver protocol-specific country recommendations including solid data-driven rationale
• Lead the development of an integrated operational strategy: Develop evidence-based strategy to successfully recruit patients for clinical trials and deliver enrolment scenarios aligned to the agreed strategy utilizing available modeling tools and techniques

Articulate and defend the proposed strategy Both internally and externally:

• Develop strong selling proposal text to deliver the agreed compelling strategic approach to meet Parexel’s optimum delivery plan considering Sponsor specific requirements.
• Prepare compelling slides to present the strategy for study delivery, country and site selection, and optimized scenario plan.
• Attend Bid Pursuit Meetings to present the integrated strategy to support the winning of new business as well as and General Capability Meetings.

Thought leadership / Therapy Area expertise: Within assigned TA, actively contribute to relationship building activities with clients and investigators / thought leaders

• Drive therapy area KPIs including reducing zero enrolling investigators.
• Innovate and evolve the approach within assigned TA, i.e., use of optimized strategy using innovative solutions / vendors / data sources
• Oversee gold standard paid feasibility “early engagement’ projects for clients to develop deeper relationships

Skills:

• Autonomous, driven, competitive 
• Independent thinker with significant operational and commercial awareness 
• Exceptional analytical and problem-solving skills 
• Developed leadership and mentoring skills 
• Effective interpersonal, presentation, oral and written communication skills 
• Capability to work in a matrix environment and to value the importance of teamwork

Knowledge and Experience: 

• Very strong experience in the Pharmaceutical/CRO Industry within Clinical Research and/or Sales operations 
• Strong experience in Project Management/Clinical Management/Feasibility Management of global clinical trials 
• Experience in or associated with CRO proposal process and solution development 
• Experience in strategic drug development planning or significant involvement in planning clinical or operational strategy preferred 
• Demonstratable expertise and experience in clinical trial feasibility assessments

Education:

• Undergraduate Degree
• Further degree. MSc, MBA, Ph.D. (preferred)
• Scientific/Medical/Nursing background 
• Fluent in English, oral and written

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About the Role

We are seeking a Senior Clinical Data Manager to join our team in South Africa in a permanent, full-time capacity.

• As a Senior Clinical Data Manager, you will play a critical role in supporting global commercial and development programs by leading clinical data management activities across Phase 1-4 studies. This position is central to ensuring the quality, integrity, and reliability of clinical trial data that support the development of innovative therapies for patients worldwide.
• You will serve as a key data management leader within cross-functional study teams, driving the planning, execution, and oversight of data management deliverables throughout the clinical trial lifecycle. Responsibilities include leading study-level data management activities, collaborating with internal stakeholders and external vendors, supporting electronic data capture system development and validation, overseeing database lock activities, and ensuring compliance with regulatory requirements and industry standards.
• You'll join a fast-paced, growth-oriented environment where your expertise will directly influence study outcomes, operational excellence, and the successful delivery of clinical research programs.
• With opportunities to work across global studies and collaborate with experienced clinical development professionals, this role offers a meaningful path for continued professional growth and leadership within clinical data management.

Key Responsibilities

• Lead large clinical studies or a series of related studies with minimal guidance
• Represent Data Management on cross-functional clinical trial working groups for assigned studies
• Oversee and monitor data management activities performed by CROs and external vendors while building effective working relationships
• Review clinical protocols and provide leadership on data capture strategy, eCRF design, and data collection requirements
• Collaborate with CRAs, programmers, study managers, statisticians, and other stakeholders to develop annotated eCRFs and completion guidelines
• Lead the development of data edit check specifications, data listings, and study-level data management plans
• Coordinate the design, testing, and implementation of Electronic Data Capture systems and resolve system-related issues
• Review and provide feedback on study documentation, including monitoring plans, statistical analysis plans, and vendor specifications
• Conduct data reconciliations, including Serious Adverse Event reconciliation and external data source reconciliation activities
• Lead database upgrades, migrations, user acceptance testing, database freeze activities, and database locks in accordance with company procedures
• Maintain study workbooks, data management files, and study documentation
• Mentor and train data management team members while contributing to the development of SOPs, work instructions, and process improvements
• Participate in team meetings and contribute expertise that supports study and organizational objectives

Candidate Profile

You’ll thrive in this role if you bring:

• Strengths in clinical data management, project leadership, vendor oversight, and cross-functional collaboration
• Experience working within pharmaceutical, biotechnology, clinical research, or other FDA-regulated environments
• The ability to manage multiple priorities while maintaining exceptional attention to detail and data quality
• Strong communication skills and the confidence to collaborate effectively across internal teams and external partners
• Comfort working with Electronic Data Capture systems, data management technologies, clinical databases, and study documentation processes
• A commitment to delivering high-quality clinical data that supports informed decision-making and advances patient care

Required Qualifications

• BA/BS degree, preferably in a scientific or healthcare-related field
• At least seven years of experience in Data Management within the pharmaceutical or biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
• Knowledge of ICH-GCP, FDA guidance, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, and clinical trial processes
• Experience with Electronic Data Capture systems and clinical data management technologies
• Strong project management, organization, communication, problem-solving, and multitasking skills
• Proven ability to support Phase 1-4 clinical studies and work effectively with vendors and cross-functional teams
• Familiarity with database upgrades, migrations, user acceptance testing, and advanced data management processes
• Strong English written and verbal communication skills

Preferred Qualifications

• Scientific or healthcare-related educational background
• Experience within Oncology or CNS therapeutic areas
• Experience supporting Phase III pivotal clinical studies
• Experience training internal and external study team members on EDC systems and data management procedures

Benefits and Compensation

• Medical Aid Contribution
• Gap Cover
• Life Assurance
• Provident Fund (8%)
• 13th Cheque