cGxPServe

Responsibilities: Perform data manipulation analysis and reporting of clinical trial data. Develop and maintain department/system-level macros. Create and review SDTM and ADaM specifications. Create and validate SDTM data sets. Create and validate analysis data sets. Create and valid More...

Responsibilities: The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department. Serve as the regulatory core team lead an More...

Roles & Responsibilities: Lab CSV consultant needed. Working on standard lab equipment systems temp monitoring systems will be the first but will also include HPLC GC and various other lab equipment. helping define a program and plan for validation. Work cross functionally with decis More...

Responsibilities: Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience. Bachelor of Engineering / Diploma in Mechanical or equivalent. Knowledge of Design History file Device History Record and Device Master Record documents. Proficiency in Project management More...

Responsibilities: Reporting to the Clinical Data Manager youll be responsible for the development of real-world data variables from structured and unstructured data sources including designing data capture forms and supplemental procedures to instruct the abstraction process. Youll l More...

Responsibilities: Responsible for independently leading data management study activities CRO oversight and driving deliverable timelines. Strong knowledge of EDC builds utilizing RAVE. Represents data management function on the Clinical Sub-team ensuring aligned expectations between More...

Responsibilities: Generating and validating statistical programming deliverables (SDTM ADAM TFLs) in Early Development Statistics and PK/PD Modeling and Simulation spanning all therapeutic areas. Performing data manipulation analysis and reporting of clinical trial data both safety a More...

Responsibilities: Demonstrated practical understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry. Demonstrated satisfactory ability to apply SAS programming knowledge and work independently to solve problems related to non-routine situation More...

Job Description: This position assists in the establishment implementation and maintenance of programs crafted to assure control of processes and products toward established standards of quality. The position uses problem solving techniques to increase quality and efficiency within th More...

Job Description: The CSV Engineer will play a critical role in ensuring that all computerized systems used in the manufacturing and quality systems of medical devices are validated according to applicable regulations such as FDA 21 CFR Part 11 EU Annex 11 and ISO 13485. This role ensu More...

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 More...

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 More...

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 More...

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 More...

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 More...

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 More...

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 More...

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 More...

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 More...

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 More...