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Roles & Responsibilities: Strong Experience with Test Method Validation and MSAs. Strong Risk Management Experience (Experience in Risk Documentation: Write review approve multiple quality records includes but not limited to: Design Files Risk Management files RPM P1 and P2 calculati المزيد...
Responsibilities: Review and ensure accurate and high-quality statistical programming deliverables from CRO. Perform generation validation and QC/QA of SDTM ADam and TFL output in accordance with SOPs SOIs and guidance documents. Create and maintain specifications as per SDTM/ADaM st المزيد...
Responsibilities: Lead and manage clinical data management activities for oncology clinical trials ensuring adherence to project timelines budgets and quality standards. Provide strategic oversight and direction to CRO clinical data management teams for assigned studies. Develop and المزيد...
Responsibilities: Manage all data management activities according to quality standards and regulatory requirements ensuring adherence to project timelines and budget. Oversee the development of CRFs and CCGs with other functional area representatives ensuring all data management data المزيد...
Responsibilities: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS) Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products including regulatory responsibilities in associated change control an المزيد...
Responsibilities: Effectively designs and codes SAS programs using BASE/SAS SAS/STAT SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM and ADaM standard datasets. Creates and validates tables figures and listings (TF المزيد...
Responsibilities: Prepare and review CMC submission documents registration dossiers health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision. Responsible for the global regulatory evaluatio المزيد...
Job Description: The Data Manager Data Management Oncology Early Development (OED) is a member of the Data Management and Analysis team responsible for supporting the successful delivery of data and processes conducted by CROs. This individual will collaborate closely with the Data Ma المزيد...
Responsibilities: Review and validate vendor-provided system documentation for serialization/track & trace systems (e.g. Optel Systech Trace Link). Develop and execute a risk-based validation strategy aligned with company and regulatory standards. Create or refine UAT scripts execute المزيد...
Responsibilities: Under the direction of the applicable management the Clinical Data Manager (CDM) is responsible for executing end to end data management activities pertaining to clinical trials including but not limited to; data management tool and system development validation and المزيد...
Responsibilities: The Senior Manager of Statistical Programming is a leadership role which manages a team of statistical programmers in the research and development of new pharmaceutical products. The Senior Manager of Statistical Programming is responsible for leading the statistica المزيد...
Responsibilities: Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of companies products. This section cont المزيد...
Job Description: We are seeking to add top talent to our Materials Support team. The Material Handler performs operations of the Supply Chain/Materials Management department with awareness and knowledge of the various areas of the operations in Goods Receipt Goods Issue Warehousing In المزيد...
Responsibilities: Regulatory Labelling Documentation. Support the creation and maintenance of assigned labelling projects to enable worldwide regulatory submissions. Independently prepare and maintain the Tracking Sheets for the global regulatory dossiers related to labelling project المزيد...
Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies guidelines and procedures. Develops protocols and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validat المزيد...
Responsibilities: Support clinical trial applications submitted via Clinical Trial Information System (CTIS) uploading documents Qin documents uploaded to ensure accurate categorization. Track CTIS application details to compile metrics Monitor CTIS notifications received due dates a المزيد...
Responsibilities: Lead the development validation and documentation of CDISC-compliant SDTM and ADaM datasets for CNS clinical trials ensuring traceability from raw data through analysis outputs. Program and QC tables listings and figures (TLFs) for interim and final clinical study r المزيد...
Responsibilities: The role includes obtaining and maintaining regulatory approvals supporting quality management system (QMS) objectives and ensuring adherence to applicable regulatory standards. The Regulatory Affairs position is responsible for global product registrations and ensu المزيد...
Responsibilities: Conduct statistical programming and analysis of clinical research studies. Provide programming support for publication efforts and regulatory submissions. Manage the timely creation review completion and delivery of statistical programming activities and deliverable المزيد...
Responsibilities: In this critical role you will lead regulatory strategies product submissions and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA) EU (MDR) China (NMPA) an المزيد...