Vacancies at ICON plc

The Role:

• Lead KOM with internal teams for Site Audit finding review. 
• Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented.
• When appointed lead auditor, perform the duties assigned in an efficient and effective manner. This includes liaison with the operations and/or operational lead on all QA issues, including review of audit responses, where applicable.
• Support Internal teams with Site Audit response management within ICON’s ACMS. 
• Verification of audit CAPA completion where required by procedure.
• Review work instructions and procedures, contributing to continuous improvement.
• Keep the person whom the QA Auditor reports to informed of any QA issues within the department that require attention.

What you need:

• Bachelors’ Degree in a related field (scientific background preferred)
• 3 years of relevant experience.
• GCP auditing background preferred.
• Attention to detail and high ethical standards is required.

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• The employee is expected to embrace and where possible contribute to our culture of continuous process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs.
• Perform timely and accurate task progress communication and data entry of all relevant study start up activities into the appropriate tracking system.
• Coordination of all necessary translations required for any start-up documentation.
• Attend study team meetings as required.

Responsible, as assigned, for one or more of the following tasks related to each of the key study start-up activities:

• Assists in identifying study sites by performing site feasibility and recruitment tasks
• Sets up and maintains site-related data in applicable clinical systems according to procedures and guidelines.
• Acts as primary site contact/liaison for study and site management issues relevant to study start-up, including addressing questions, inclusive of protocol questions, managing study supplies and accesses to applicable study systems.
• Preparation, submission, review and approval of IP Release Package (IPP)
• Essential document collection and review, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable country requirements and ICH/GCP guidelines.
• Ensure accuracy and completeness of Trial Master File (TMF) documents submitted during start-up.
• Support in forecasting site activation timelines and ensure they are reflected accurately in ICON’s systems and are achieved; work with Site Activation Lead to prepare contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified.
• Support local regulatory team with submission coordination activities, including relevant local document collection. Submission and coordination of any applicable local submissions including LEC submissions.

What You Need:

• English and Afrikaans speaker
• A high school diploma or local equivalent
• Bachelor’s Degree preferably in Life Sciences
• Minimum of 1 years’ experience or understanding of clinical study start up requirements and activities.
• Experience of Clinical Trial operations and meeting regulatory guidelines, including performing LEC submissions.

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What You Will Be Doing:

• Assist senior biostatisticians in clinical study support, including study design, sample size calculations, patient randomization, data analysis, and results reporting.
• Support the statistical aspects of case report form design.
• Help in writing statistical analysis plans, defining derived data, and designing statistical tables and figures for clinical summary reports.
• Write data quality control specifications, utilize relevant computer languages and software.
• Develop and execute data manipulation and analysis programs.
• Assist in conducting statistical analyses and interpreting results.
• Prepare statistical summary reports and contribute to the statistical methods sections of integrated study reports.
• Review and document analysis and programming work for audit trail purposes.
• Contribute to project document standards and maintain project-specific biostatistics files.
• Collaborate effectively with ICON project team members, including data management, statistical programming, and clinical research personnel.
• Embrace ICON's values, culture of process improvement, and commitment to client needs.

Your Profile:

• Bachelor’s degree in Statistics or a related field.
• Experience in a biostatistics role in the pharmaceutical, clinical research, or healthcare industry is preferred.
• Proficiency in statistical concepts, study design, sample size calculations, and patient randomization.
• Familiarity with statistical analysis plans and the design of statistical tables, figures, and data listings for clinical reports.
• Strong data analysis skills, including data manipulation, retrieval, and interpretation.
• Proficiency in relevant computer languages and statistical software packages.
• Ability to write and implement programs to select, retrieve, manipulate, edit, and analyze data.
• Competency in assisting with statistical analyses and result interpretation.
• Effective communication and collaboration skills to work with cross-functional teams, including data management personnel, statistical programmers, and clinical research colleagues.

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Job Description:

Functional Knowledge:

• Expert knowledge of clinical data science activities (data management/clinical systems/clinical data risk) .

Business Expertise:

• Ability to understand protocol content in the context of clinical data management/clinical data science delivery.
• Provides consultation for clinical data science best practices (processes, systems, regulations etc).
• Oversees project status and escalates potential problems effectively and in a timely manner to ensure functional management and those responsible for project management informed of critical issues that might affect project target dates, scope or budget.
• Works independently and, as needed, able to manage escalations with clients and/or external customers and departments.
• Point of escalation internally/externally.
• Other responsibilities may be assigned as required
• Travel (approximately 15 %) domestic and/or international

Leadership:

• Strong leadership and project management skills
• Typical years of experience 10+. An equivalent combination of education, training and relevant experience may be considered in place of the education and experience stated.
• Established Mentor and or SME.
• Accountable for all CDS project delivery milestones and internal reporting and progress reports for assigned projects
• Holds primary accountability for delivery oversight for CDS standalone projects

Problem Solving:

• Problems are complex in nature. Limited precedence or guidance may not be available. Undertakes analysis and investigation to identify and define problems. Anticipates future issues.

Impact:

• Oversight of number of clients or program work in a client partnership
• Supports clinical data science strategic plans at client level.
• Reviews project proposals and attends bid defenses as a representative of the function when required.

Financial Management

• Performs financial review of projects under their span.
• Guides project team with respect to out-of- scope tasks.
• Oversight management and forecasting within financial tool utilized 
• Review financial documentation and assess preparedness related to all clinical data science activities from planning through data delivery/close out.
• Approves Worked Units, Forecasted Units and project invoices monthly

Interpersonal Skills:

• Adapt style and use persuasion in delivering messages. Presents and defends analysis and secure approval on complex matters.