cGxPServe

Responsibilities: Manage end-to-end delivery of data management services concurrently for single/multi-service projects with little-to-no guidance ensuring quality deliverables on time and within budget to customer satisfaction. Provide comprehensive data management expertise to Clin More...

Responsibilities: Perform validation and QC of the programs datasets and statistical reports per study requirements. Develop and review CDISC SDTM and ADaM mapping specifications. Responsible for study closeout and providing submission-ready statistical programming deliverables to th More...

Job Description: As a Senior Supplier Quality Engineer you have a unique impact on the quality and reliability of our devices. You will work with cross-functional teams to maintain and improve the Quality System within the requirements of FDAs Quality System Regulation (QSR) ISO 13485 More...

Responsibilities: Work as an onsite Process Engineer in a process plant environment. Deliver designs and Engineering packages related to process engineering for industrial plants. Define the scope of work discussing with customer coordinate with the offshore team and deliver the engi More...

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 More...

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 More...

Job Description: The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for cl More...

Responsibilities: Manage assigned projects to ensure thoroughness accuracy and timeliness of CMC dossiers and responses. Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental app More...

Job description: The Medical Writing Word Processing Coordinator is responsible for formatting proofing and completion of Clinical Protocols Clinical Study Reports Investigators Brochures and other related clinical regulatory documents. Provides document formatting support to Medical More...

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...