- Daiichi Sankyo, Inc. (Bernards, NJ)
- …not limited to CRF/eCRF design, all steps from database development to database release, data review and cleaning, database lock), to ensure data ... compliant across studies and programs.- Promotes Risk Based approaches to data cleaning and review - Proactively collaborates cross-functionally during… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …driving compliance.Ensure readiness of records for regulatory inspections and internal audits. Review , compile, and organize batch data . Review , compile, ... the team responsible for QA oversight of final CAR-T product batch record review and release practices.Lead the establishment and improvement of QA practices to… more
- Genmab (NJ)
- …reports, as applicable Perform exploratory analysis, ad hoc analyses, and modelling of data Review and approve randomization and stratification plans Perform UAT ... discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and information… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …Provide medical oversight during clinical trials to ensure participant safety and data integrity. Review and interpret safety signals, adverse events, and ... efficacy data in collaboration with pharmacovigilance teams. Target Product Profile (TPP) Contributions: Develop and refine TPPs by outlining desired product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will ... utilities, and facility qualification, process validation, shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical or medical lead and biostats to ensure availability of necessary data - Coordinate author review /approval internal review approval- ... in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures and author… more
- Aequor (Vacaville, CA)
- …of basic and moderately complex tests with documentation according to GMP Review data and assess against established acceptance criteria Perform technical ... review of peer-generated data Evaluate data to identify trends and/or establish limits Identify discrepancies; provide input to design of quality… more
- Aequor (Thousand Oaks, CA)
- …Proof of Receipt (POR) - Support reconciliation and return of investigational products Temperature Data & Quality: - Review shipment temperature data and ... assess excursions with Quality partners - Communicate with study managers and pharmacy staff regarding distribution or temperature events - Capture KPIs, analyze trends, and support corrective actions Other activities: - Participate in international, cross… more
- BioAgilytix (Durham, NC)
- …and manage studies in LIMS; maintain accurate laboratory records, worksheets, and raw data with peer review .Train, mentor, and direct junior scientists and ... budget, and revenue management.Act as primary client contact, presenting data , ensuring clear communication, and aligning project deliverables with client… more
- SR International, Inc. (Phoenix, AZ)
- …computer technology. Use automated accounting systems and applications to retrieve and review data files, analyze information, and analyze financial records in ... if required (10% Onsite, 90% Remote) Job Description: Penalty Review Specialist: Examine and analyze data as...Description: Penalty Review Specialist: Examine and analyze data as presented by the customer applicant for consideration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reviews overall processes and identifies areas of concern, arranges for remediation. Performs review of data entry convention documents, PVA reviews and SAE flow ... project. This position prepares trainings, supports CAPA investigations, case review , documentation reviews in collaboration with the ICSR management...plan / data management plan reviews. Works with ICSR management and… more
- Novo Nordisk Inc. (Durham, NC)
- …maintenance, including restoration of lost function, predictive & preventative maintenance Record/ review production data in BPR & associated forms Follow ... all safety & environmental requirements in the performance of duties Other duties as assigned Physical Requirements Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects… more
- Lundbeck (Bothell, WA)
- …REBEL amino acid analyzer.Share responsibility for equipment maintenance and upkeep. Review DNA sequencing data (including NGS), Southern/Northern blots, ... quantitative PCR results. Author and review cell line development technical reports that meet expectations...ability to effectively and independently manage laboratory work and data , including capturing data accurately in appropriate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documentation ( ie F&B receipt, AV, sign in sheet, etc.)Run agg spend data reporting for each meeting. Review findings with ManagerAddress any inconsistencies and ... process, to ensure information is documented and reported timely.Folder Audit includes: Review HCP Engagements that are considered closed according to the policy… more
- Genmab (NJ)
- …and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety:Participate in definition, review , and approval of data packages for Data ... discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and information… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams providing the safety leadership and serving as the primary point of contact. Review and analyze data from clinical trials, post-marketing and other relevant ... compound/product including project-specific training and coaching of team members and review of team output cross-functionally.Effectively represent the CSPV on the… more
- Geisinger (Danville, PA)
- …improvement report and forwards initial review to leadership for secondary review and action.Coordinates data collection for formal quality improvement focus ... to enhance patient care and outcomes.Assists in collection and interpretation of data pertinent to the Trauma PI Program and Trauma Registry.Maintains trauma roster… more
- Lamar Advertising Company (Edgewood, NM)
- …Monitor customer payments and collections Responsible for the completion and compilation of data , and review all reports required by the Department of ... Transportation (DOT) Review site plans, as-builts (check to ensure correct location...job opportunities, hiring events, and career-related updates. Message and data rates may apply. You can opt out at… more
- Tunnell Consulting (Berwyn, PA)
- …program. The QC/Analytical SME will provide subject matter expertise in analytical testing, data review , and GMP documentation practices. QC SME partners with QC ... Responsibilities: Review QC documentation, including analytical test records, raw data , and final reports, for completeness, accuracy, and compliance with GMP,… more
- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …in a timely manner. Ensure quality data management activities - ie, data review , query generation and resolution. Generate status reports to clinical staff ... site management and interact with site coordinators, investigators, and field monitors in collecting data and resolving queries to meet the protocol requirements… more
