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Patient Mix: 11 bed unit with IMC/Tele; Hematology/oncology, chemo, autologous bone marrow transplant and CAR-t (Stem cell) overflow, bone marrow biopsy, new luek inductions, multiple transfusions, count recovery, and clinical trials.
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Review/approve creation/modifications to Master Stability Protocols (MSP) and Study-Specific Protocols (SSP), batch-specific enrollment documentation, and LIMS stability studies. The Stability Senior Scientist reports to the Senior Principal Scientist or Associate Director of GBS and is responsible for end-to-end oversight of product stability programs.
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Ensure the accuracy and completeness of SAP master data information through physical and digital verification of asset master data and standards implementation. Maintain an up-to-date reference of data sources for various work streams and digital and analog tools, including SAP, D365, SMS, PdM (Azima, ThermoStudios), SharePoints, and other relevant sources.
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This position is a member of the Cell Therapy Development and Operations (CTDO) organization, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.
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Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
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Ensures compliance with the site validation master plan, assist with facility start-up operations and product. Mountain RAM) and quality systems software (e.g. Veeva). Must have knowledge and experience with GMP, Quality and compliance.
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Understanding of Fieldglass and Ariba Master Data and impacts on end to end process. Maintain master files that are used in configuration of the Ariba application. Responsible for P2P Dashboard contents and provide support for business requests of Ariba data across the various modules.
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Under the direction of the applicable management, the Lead Clinical Data Manager (LCDM) 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 maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with Sponsor Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
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And we’re not only a one stop shop, but our technicians and master mechanics can compete with the many new car dealers, tire center and repair facilities. Qualifications:Previous experience is required with a minimum of 1-year on the job training working for a dealership, automotive shop, tire center, or quick lube.
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Intermediate knowledge of quality systems including CAPA, change control, and document management systems. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP.
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Must have a mastery knowledge of enterprise intrusion systems, fire systems, CCTV, intercom access control systems.
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Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. The on-site, Baltimore, MD, Controller will establish and maintain proper accounting policies, ensure timely and accurate financial reporting, coordinate internal & external audits, and oversee the SOX internal controls.
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Saint Peter's University Hospital has provided comprehensive clinical genetic services since 1992, and the department is actively involved in gene therapy and other clinical trials for orphan drugs.
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Vitalief, a fast-growing, “best of breed” Research and Clinical Trial Solutions Company, is committed to identifying talented and passionate clinical research professionals to join our exceptional team and support our clients in planning and executing successful clinical trials.
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Administratively support and attend trials Prepare case briefs and summarize depositions, interrogatories, and testimony Conduct investigations and statistical/documentary research Locate and develop case-relevant information Type up and file basic legal documents and correspondence Answer and direct phone calls Maintain contact lists Monitor deadlines and juggle calendars Skills/Qualifications: Proven working experience as a Legal Assistant or similar; preferred.
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trials trial master file jobs Title: trial master file in Edison, NJ
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