Career Opportunities at Parexel

About the job

• Deliver best value and high quality service.
• Check own work in an ongoing way to ensure first-time quality.
• Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.
• Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.
• Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.
• Proactively participate in process/quality improvement initiatives.
• Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).

Qualifications

• Excellent analytical skills.
• Proficiency in SAS.
• Knowledge and understanding of the programming and reporting process.
• Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
• Ability to learn new systems and function in an evolving technical environment.
• Ability to manage competing priorities and flexibility to change.
• Attention to detail.
• Ability to successfully work as part of a global team.
• Work effectively in a quality-focused environment.
• Effective time management in order to meet daily metrics or team objectives.
• Show commitment to and perform consistently high quality work.
• Business/operational skills that include customer focus, commitment to quality management, and problem solving.

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The Principal Statistical Programmer (FSP) will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors, and works independently to support various programing activities related to the analysis and reporting of clinical study data. In addition, the Principal Statistical Programmer can fill the Primary Statistical Programmer role on projects and liaise with sponsors, Data Operations Leads, and other functional areas as required. Furthermore, the Principal Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.

Skills:

• Proficiency in SAS Proven Lead Statistical Programming experience within related environment (minimum 6 years experience)
• Knowledge of the programming and reporting process
• Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
• Demonstrated application of CRS concepts to achieve best practice and promote continuous improvement Demonstrate ability to learn new systems and function in an evolving technical environment
• Strong leadership ability.
• Ability to successfully work together with a (“virtual”) team (including international teams as required) as well as independently
• Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change
• Attention to detail.
• Excellent analytical skills.
• Good presentation skills.
• Tenacity to work in an innovative environment.
• Ability to negotiate and influence in order to achieve results.
• Business/Operational skills that include customer focus, commitment to quality management and problem solving. Good business awareness/business development skills (including financial awareness).
• Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
• Work effectively in a quality-focused environment.
• Demonstrate commitment to refine quality processes.
• Effective time management in order to meet daily metrics or team objectives
• Show commitment to and perform consistently high quality work

Education

• Educated to degree level in a relevant discipline and/or equivalent work experience

Language Skills

• Competent in written and oral English.
• Excellent communication skills.

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RESPONSIBILITIES

Parexel FSP is currently seeking Senior Clinical Research Associates & CRAII, home-based, Johannesburg. Working as a Clinical Research Associate at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.

Whether you see your future path as a CRA, or in fields such as clinical operations, project management, line management, or other positions, we have a world of opportunity waiting for you. Our CRAs work from their home office base, supporting studies within their country or region. ‘Manageable sites, manageable protocols’ is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.

Some specifics about this advertised role

• Dedicated to one client.
• Responsible for all site management and monitoring activities across assigned oncology studies
• Work with industry leaders and subject matter experts.
• Opportunity to mentor junior CRAs.
• Work with world-class technology.
• Great opportunities to travel, work from home, meet new people and play a pivotal role in the drug development process.

Here are a few requirements specific to this advertised role.

• Substantial Site Management experience, with an understanding of clinical trials methodology and terminology.
• Experience monitoring or willingness to monitor oncology clinical trials.
• Experience in independent monitoring, all types of visits.
• Effective time management, organizational and interpersonal skills & problem-solving skills, with the ability to multi-task and prioritize.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

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Job Purpose:
The Clinical Data Engineer II provides technical expertise for the conduct of clinical trials and works to support various activities related to electronic data, and/or the applications/systems within eClinical technologies. General areas of responsibility also include: Aggregating applicable data from all sources and devices, managing external data, programming offline listings, trend analysis, data review, data transfers. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.

Key Accountabilities:
Manage electronic Data & Technology

• Lead and implement the setup of Data Receipt Agreements with vendors by working with cross functional teams.
• Programming and setup of Import procedures to allow the ingestion of data either using SAS or alternative technology (e.g. “Workbench”).
• Programming of reconciliation checks to ensure appropriate transfer of data.
• Programming of offline listings and custom reports to allow better insights to all external data.
• Aggrege data across all sources.
• Handling Missing Values, reading raw data files, creating data structures, handling programming errors, accessing, and managing data, appending and concatenating SAS datasets.
• Review of data using created outputs with aim of providing insights to study teams and clients.
• Coordinate and lead a programming team to successful completion of a study within given timelines and budget.
• Manage the deployment of the DM technology used for creation of offline listings (e.g. Workbench, SAS or R).

Support Projects

• Assist in providing technical solutions to internal or external/client enquires.
• Ensure adherence to service levels agreements with regard to the turnaround time from the point when specifications are finalized.

Support Initiatives

• Participate in the creation of standards, either through tools (e.g. SAS Macros), libraries or processes, as required for GDO to ensure efficient, effective and optimal processes.
• Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies.
• Act as a mentor and/or SME.
• Provide relevant training and mentorship to staff and project teams as appropriate.
• Assist in providing technical solutions to internal or external client enquires.

Account Leadership

• Point of contact for clients and within Parexel for electronic data specific matters.

Ideal candidate will possess:

• Bachelor’s degree in a relevant discipline.
• Experience in clinical research industry or similar field is required.
• SQL experience.
• Experience in ETL Programming environment (e.g. Oracle Workbench, Elluminate, SAS, Python, etc.).
• Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies, ICHGCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
• Written and oral fluency in English.
• Strong ability to lead and collaborate with global teams and work independently. Motivate/guide virtual teams across multiple time zones and cultures to work effectively.
• Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach.
• A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments.
• Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust.
• Proficient presentation skills.
• Good business awareness/business development skills (including financial awareness).

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The Principal Statistical Programmer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors, and works independently to support various programing activities related to the analysis and reporting of clinical study data. In addition, the Principal Statistical Programmer can fill the Statistical Programming Lead role on projects and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas as required. Further, the Principal Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.

• Excellent analytical skills with proven SAS programming experience and sound project lead experience.
• Advanced knowledge of SAS programming techniques.
• Extensive knowledge and understanding of the programming and reporting process.
• Good knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
• Knowledge of the efficacy endpoints and analysis techniques specific to the disease being treated. Ability to learn new systems and function in an evolving technical environment.
• Strong project management skills.
• Strong organizational skills, ability to manage competing priorities, and flexibility to change.
• Attention to detail. Ability to successfully lead and mentor a global team.
• Work effectively in a quality-focused environment.
• Excellent time management in order to meet daily metrics or team objectives.
• Show commitment to and perform consistently high quality work.
• Strong business/operational skills that include customer focus, commitment to quality management, and problem solving.
• Demonstrate commitment to refine quality processes.
• Good presentation skills.
• Ability to negotiate and influence in order to achieve results.
• Good business awareness/business development skills (including financial awareness).
• Client-focused approach to work.
• Good negotiation skills.

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The System Set-Up Analyst (SSA) ensures the technology set-up at a clinical trial’s outset supports the profitability of the trial, ensures quality delivery, and maximizes the efficiency of operational resources assigned to the trial. For assigned trials, the SSA has global responsibility for the design, requirements gathering, requirements documentation, and the accountability for the implementation of technology to meet the specific needs of the assigned trials. The SSA will work with Parexel’s standard technology, and if non-standard technology is required, the SSA will escalate to their assigned Client Technology Partner.

Key Accountabilities

• Serve as the single point of contact with the project team for trial-level technology, and data integration solutions, covering CRS, PI, IT, and technology third party vendors
• Define and document requirements for the trial technology
• Be accountable for all technology set-up for assigned trials; this includes working with colleagues across departments who have specific responsibilities for part of the set-up
• Coordinate the teams responsible for delivery of the technology for a trial, including design, using standard components, based on customer requirements, planning and coordination of delivery of the technology and input to the overall project plan
• Ensure the quality, timeline and budget related to the trial technology meets the project requirements
• Escalate requests or requirements for non-standard technology to the assigned Client Technology Partner
• Set-up trial technologies if appropriate
• Ensure project team satisfaction of the trial technology solution
• Train and mentor more junior System Support Analysts
• Stay updated on technology and clinical trial process developments and requirements within Parexel

Ideal candidate will possess:

• Excellent verbal and written communication skills
• Strong customer focus (internal and external)
• Coordinating global virtual teams around trial technology set-up
• Proven ability to manage independently competing priorities with attention to detail
• Good project management skills
• Ability to motivate and work effectively with virtual teams within different cultural environments
• Technical and data standard experience
• Experience in clinical trial systems (e.g, CTMS, EDMS, EDC, IVRS, reporting tools) and in configuration of these systems
• Ability to develop detailed awareness of Clinical Research Services, external vendor software and tools with practical knowledge of how these applications work, and provide efficiency to operations
• Demonstrated adeptness in learning new systems and function in an evolving technical environment
• Awareness/experience in the needs and use of data standards in clinical trial environment; if possible knowledge/experience of data standards such as CDISC SDTM
• In depth understanding and experience of clinical trial processes
• Knowledge of SOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application