Fresh Jobs at PAREXEL

About This Role

• Parexel is currently seeking a Project Specialist (Medidata Rave) to join us in South Africa, dedicated to a single sponsor.
• This role will be responsible for the administration and support of the Medidata cloud platform. It involves creating and managing user accounts, sites, ensuring proper access controls, and maintaining data integrity within the Medidata Rave EDC system. You will work closely with various teams to facilitate user access, compliance with training requirements, and the efficient management of user data. Additionally, you will support system validation processes to ensure that the Medidata platform operates in accordance with regulatory and compliance standards.
• Working as a Project Specialist (Medidata Rave) 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.
• Expect exciting professional challenges in inspiring studies, but with time for your outside life.
• This will be a fully remote home-based position.

Responsibilities

• Create new user accounts within Medidata Rave EDC and other EDC systems such as Veeva CDMS systems.
• Ensure correct user roles and permissions are assigned based on study requirements.
• Collaborate with study teams to ensure accurate and timely user assignments.
• Periodic review of user access across the platform to ensure only valid users always have access to the studies.
• Administer and manage study and site assignments.
• Assign required eLearnings and report matrices to all studies in adherence to the internal procedures. Participate in system validation activities to ensure the Medidata platform meets regulatory and compliance standards.

Here are a few requirements specific to this advertised role.

• Bachelor’s Degree in a relevant field and a minimum of 2 years’ relevant experience (3 is preferred). An equivalent combination of education and experience may be considered.
• 3+ years of Medidata Rave EDC/Veeva CDMS experience in study administration, site administration, and user administration.
• Attention to detail and the ability to work individually, within a multi-disciplinary team.
• Strong English language written and verbal communication skills.
• Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications.

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About This Role
Key Functions of this PS Role:-

The Project Specialist I;

• is developing project plans, providing project level reports and metrics to inform project oversight, progress reporting and decision making by the Project Leader (PL) and Functional Leads (FLs), to ensure timeliness and quality of project deliverables and control the project budget.
• will be predominantly assigned to late phase and Enterprise projects.
• is working on under Line Manager oversight in all project lifecycle phases and depending on the acquired experience and independence, an assignment to Biotech& Emerging client’s projects, as well as to assist project start up and close out can be considered.

Knowledge and Experience you will require to qualify for this role:

• Relevant basic experience in the PS/ or similar role desirable
• Basic knowledge of activities and procedures of the work area and exposure to / knowledge of the related industry is preferred
• Good Knowledge of Microsoft based applications

Essential Skills Required:

• Good verbal and written communication skills, as the exchange of information is a significant part of the job
• Developed interpersonal skills and ability to build relationships
• Attention to detail and quality of work
• Client focused approach to work
• Flexible attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm
• Ability to prioritize workload
• A willingness to work in a matrix environment and to value the importance of teamwork
• Basic problem- solving ability

Minimum Education Requirements:

• Intermediate to Advanced English level for non-native English speakers
• Minimum Bachelor’s degree or equivalent degree

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About This Role
The Senior / Principal Statistical Programmer overall duties include;

• provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programing activities related to the analysis and reporting of clinical study data.
• can fill the Statistical Programming Lead role on projects, and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas as required.
• will monitor quality, timelines, resource allocation, and productivity in relation to budgets.
• 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.
• can fill the Statistical Programming Lead role on projects and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas as required.
• will monitor quality, timelines, resource allocation, and productivity in relation to budgets.

Knowledge and Experience Required:

• Proven record of successfully leading teams in a statistical programming environment with sound Clinical / SAS Programming experience (minimum +3.5 years related experience is essential to be considered for a Senior level. 5yrs + with Lead Programming experience is required for Principal level).
• Competent in written and oral English.
• Excellent communication skills.

Skills Required:

• Excellent analytical skills.
• 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.

Education Requirements:

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

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About This Role

• The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects.

Essential Skills, Knowledge and Experience Required for this Role:

• Excellent analytical skills.
• Proficiency in SAS with solid knowledge and understanding of the programming and reporting process. A minimum of 1.5 years Clinical (SAS) Programming experience is required.
• 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.
• Competent in written and oral English.
• Good communication skills.

Education Required:

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

Key Accountabilities of the Role:

Accountability Supporting Activities Project Management;

• Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.

Statistical Programming for Assigned Projects;

• 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.

Training;

• Maintain and expand local and international regulatory knowledge within the clinical industry.
• Develop knowledge of SAS and processes/procedures within other Parexel functional areas.
• Provide relevant training and mentorship to staff and project teams as appropriate.

General;

• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
• 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).