Jobs at PAREXEL

About this Role

• Parexel is currently seeking a Risk Manager to join us in South Africa, dedicated to a single sponsor.
• This role will be responsible for facilitating Risk-Based Quality Management (RBQM) conduct on assigned trials, by leveraging knowledge of relevant regulatory requirements and sponsor processes
• It will provide training and support to Clinical Trial Working Groups (CTWGs) on all aspects of risk identification, evaluation, acceptance, control and communication, from study concept to close-out on assigned Phase I – IV trials (in house or outsourced).
• Working as a Risk Manager 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.

Responsibilities

• Conduct all activities of ‘Risk Manager’ for assigned clinical trials, per sponsor RBQM process.
• Provide training and guidance to CTWGs on risk process.
• At the time of Study Concept Document development, facilitate the identification of critical data and processes and records these within the risk tool (file or RACT technology solution).
• Sets up trial-specific RACT.
• Facilitate trial risk assessment by cross-functional CTWG for assigned trials, advising on risk identification, evaluation, acceptance, control, review and communication as appropriate throughout the conduct of the trial.
• Collaborate with appropriate trial contributors in establishment of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) for critical risks as well as KRIs and thresholds for non-critical risks, advising on approach and best practice.
• Approve initial risk assessment version, substantial updates and final version.
• As applicable, liaises with vendor/CRO as early as possible to ensure cross-functional sponsor input into vendor/CRO risk assessment.
• Coordinate establishment of trial risk-based monitoring strategy in conjunction with CTWG, Electronic Data Capture programmer and Global Monitoring.
• Contributes to development of data review specifications, and specified data reviews.
• As applicable, contributes to and oversees vendor/CRO risk management activities as defined in the Trial Oversight Plan, reporting performance/concerns to AD, RBQM.
• Facilitate review of the risk tool at the frequency and per triggers defined in the Trial Oversight Plan.
• Where a critical risk is realized (QTL breached) contributes to root cause analysis, action plan and ensures contemporaneous record of the QTL breach, remedial actions and outcomes is documented in the risk tool.
• Contribute to maintenance of risk process, templates (including RAMP/RACT), guidance and tools.
• Contribute to Key Risk Indicator (KRI) library, Quality Tolerance Limit (QTL) library/approach.
• Develop expertise in RBQM technology solutions and tools; advises and supports CTWG members with their use.
• Support and promote risk process compliance (including periodic risk review) for assigned trials, providing regular updates and issue escalation to AD, RBQM.
• May coordinate periodic or ad hoc updates per trial or across program(s)/portfolio as required and presents/interprets for key stakeholders.
• Attend RBQM Cross-Functional Forums, as needed
• Champion consistency and knowledge management (Lessons Learned)​.
• Maintains continuous process improvement approach​.
• Support inspection readiness.

Here are a few requirements specific to this advertised role.

• Bachelor’s degree or equivalent required. Master's or health data sciences degree preferred.
• Operational experience in clinical trial conduct (within trial management, monitoring, data management or related field)
• Broad understanding of clinical trial operations and ability to work collaboratively across functional areas.
• Knowledge of RBQM from a regulatory and best-practice perspective.
• Experience of conducting/facilitating clinical trial risk assessment and management.
• Demonstrated capabilities in root cause analysis and effective issue resolution.
• Strong analytical and data interpretation skills.
• Understanding of statistical analysis techniques, visualizations and tools is helpful but not required.
• Ability to communicate clearly on complex topics - to train, inform, influence and convince.
• Flexible and adaptable to a fast-changing environment.
• Able to carry out responsibilities with minimal supervision.

go to method of application »

About this Role

• Parexel is currently seeking a Senior Clinical Data Analyst to join us in either South Africa, Poland, Hungary, or the UK, dedicated to a single sponsor.
• This role will be responsible for performing Data Management activities that support the sponsor’s commercial and development projects worldwide. The successful candidate will participate as an active member of a multi-disciplinary team to plan and execute the Data Management tasks required for phase I – IV studies. The Senior Clinical Data Analyst has a broad, fundamental knowledge of the data management process and can perform most required tasks with minimal guidance.
• Working as a Senior Clinical Data Analyst 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. RAVE experience is strongly preferred.

Responsibilities

• Lead a large clinical study or a series of related studies with minimum guidance.
• Represents Data Management on the CTWG for assigned studies.
• Provide mentoring and training to lower-level Data Management staff assigned to your studies.
• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts.
• Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
• Be able to perform a thoroughly detailed review of eCRF data requirements.
• Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
• Lead the development of data edit check specifications and data listings.
• Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members.
• Develop or lead the development of the Data Management Plan for a clinical study.
• Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications.
• Provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed.
• Perform reconciliation of header data from external data sources against the clinical database.
• Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines.
• Lead database upgrades/migrations including performing User Acceptance Testing.
• Maintain study workbooks and data management files.
• Perform database lock and freeze activities per company SOPs.
• Participate in regular team meetings and provide input when appropriate.
• Provide input into the development of data management SOPs, Work Instructions, and process documents; take a leadership role in the development of assigned documents.
• Contribute to a professional working environment including the application of the sponsor’s Code of Business Conduct and Ethics.
• Assist with the training of new employees and/or contractors.

Here are a few requirements specific to this advertised role.

• Bachelor’s Degree required, preferably in the scientific/healthcare field.
• Proven leadership experience.
• Good project management skills and a proven ability to multitask.
• At least five years’ or preferably up to 8 years' experience, in Data Management for the pharmaceutical/biotechnology industry.
• Understanding of the scope and focus of Phase I – IV clinical studies, and a proven ability to perform some of the core Data Management tasks and interact with vendors.
• A comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Strong English language written and verbal communication skills.
• Able to travel to meetings or training seminars on occasion.
• Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.
• Experience and understanding of the Oncology or CNS therapeutic area and with Phase III pivotal studies are desirable.

go to method of application »

About This Role

• Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Regulatory Affairs Consultant to join our dynamic team! This role is for a client dedicated project, and the role can be home based or office based in Bloemfontein.
• As the Regulatory Affairs Consultant you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for vaccines and/or biological products.

Primary Tasks & Responsibilities:

• Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
• Assess change controls and provide regulatory assessments of quality changes in production and quality control.
• Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
• Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
• Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
• Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Experience and Knowledge Requirements:

• University-level education, preferably in Life Sciences, or equivalent by experience.
• Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
• Strong understanding of CMC and post-approval regulatory requirements.
• Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations - strong plus
• Knowledge of vaccines and/or biological processes.
• Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles.
• Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
• Team spirit, flexibility, accountability, and organizational skills.
• Fluent in English (written and spoken).