- Eisai, Inc (Nutley, NJ)
- … Clinical Programming manages and oversees JReview and SAS program development for clinical data processing, data review reports and listings. This ... management, training, programming support & upgrades Manage automated process for converting clinical data to standard normalized datasets which are used for… more
- Merck & Co. (San Francisco, CA)
- …Director, DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project Manager will ... execution of our Company's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness across organizational… more
- Genmab (NJ)
- …from/to business partners in collaboration with the programmer and the data manager , as applicableCTT member:Participate and represent BiostatisticsReview and ... fit? Then we would love to have you join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as… more
- BioAgilytix (San Diego, CA)
- …and execute validation and sample analysis plansReview and evaluate PK/TK data and ISR results to identify trends and outliersPlan and execute cross-site ... you enable life-changing, life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of… more
- Genmab (NJ)
- … transfers from/to business partners in collaboration with the programmer and the data manager , as applicableEnsures state of the art statistical work which ... join us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early… more
- ACROBiosystems Inc. (San Diego, CA)
- …recombinant proteins and critical reagents/assays to support drug development and clinical applications from target discovery and validation , candidate drug ... screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion diagnostics. We are committed to excellence in… more
- BioAgilytix (Durham, NC)
- …is seeking a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies-including ... for someone with a strong background in method development, GxP-compliant validation , and targeted and untargeted analysis using chromatography and mass… more
- Astrix Technology (Albany, NY)
- …Remote (US-based) **Overview:** We are seeking a Clinical Data Manager to oversee the collection, validation , and preparation of clinical ... ** Clinical Data Manager -...** Clinical Data Manager - Remote** Clinical...plans (DMPs) and standard operating procedures (SOPs). + Perform data cleaning and validation activities, identifying and… more
- Takeda Pharmaceuticals (Boston, MA)
- …execution, build and oversight of clinical trial deliverables. Program study level clinical data validation checks, reconciliation listings and related ... job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Manager , Data Validation Engineer **POSITION...clinical trials and to the delivery of high-quality data in a timely manner, leading to statistical analysis… more
- Mount Sinai Health System (New York, NY)
- …registration and data systems. Non-Bargaining Unit, 618 - HSO Drg Validation - MSH, Mount Sinai Hospital **Responsibilities** Performs SMART focused reviews on ... **Job Description** The purpose of DRG validation is to confirm that diagnostic, procedural information,...official coding rules, guidelines and conventions to validate coded data and ensure high quality and compliance with regulatory… more
- Catalent Pharma Solutions (Somerset, NJ)
- **INTERNET POSTING** ** ** **Job Title:** Manager Computer System Validation and Data Integrity **City:** Somerset **State** : NJ **JOB DESCRIPTION** : ... business; Provide quality and regulatory oversight of the design, development, validation , implementation and ongoing maintenance and use of computerized GxP systems… more
- Regeneron Pharmaceuticals (Troy, NY)
- …and managing validation budget, contracts, and schedules. + Presenting/defending validation data to FDA and other regulatory agencies. + Maintaining ... At Regeneron, we are seeking a Manager , QA (Internal Validation Oversight) to...maintained for equipment and software use in commercial and clinical manufacturing. + Organizing QA Validation resource… more
- Bristol Myers Squibb (Indianapolis, IN)
- …entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is ... **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams. + Ensure RayzeBio computer… more
- Novo Nordisk (Bloomington, IN)
- … strategy and mentor engineers/senior engineers on execution. Relationships Reports to Manager , Validation . Essential Functions + Equipment Validation + ... utilities + Revise validation documents including protocols and SOPs + Access data and generate reports from control systems + Compile data for qualification… more
- System One (Tarrytown, NY)
- Job Title: Clinical Data Manager Location:... of clinical databases, subsequent changes in clinical databases and data validation ... Compensation: $70 - $75 hourly W2 only As a Clinical Data Temp, a typical day may...a typical day may include: + Serves as primary Data Manager contact for assigned studies, including… more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Senior Manager , Clinical Data Standards, Bristol-Myers Squibb Company** ... **,** **Princeton, NJ** **.** Develop, maintain and implement clinical data standards. Participate in the development...mapping specifications, + annotated CRFs, + CRF design, + data validation , + Metadata + Repository (MDR)… more
- Terumo Neuro (Aliso Viejo, CA)
- **12521BR** **Title:** Sr. Manager , Clinical Data Management **Job Description:** The Senior Manager , CDM oversees clinical data management ... validation , execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission. 6....well as part of a team. **External-Facing Title:** Sr. Manager , Clinical Data Management **Posting… more
- Bristol Myers Squibb (Princeton, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **Position Summary:** The Senior Manager , Data , Analytics and AI Product Engineer- Clinical Data ... the gap between technology and business needs within the Clinical Data Ecosystem (CDE) that primarily delivers... data professionals including architect, engineers, UX designer, data scientist, product analysts, scrum master, validation … more
- Edwards Lifesciences (Irvine, CA)
- …and healthier lives. Join us and be part of our inspiring journey. As the **Senior Clinical Data Manager ** , you will ensure the quality and integrity of ... reporting of safety-related issues. As well as conduct all clinical data management functions (lead clinical...Full knowledge of protocols, DMPs, SAPs, Database Specification, and Data Validation Specification + Proven expertise in… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager , CDM oversees lead Data Managers across clinical studies in specific therapeutic areas to ensure timely and high-quality data ... managing staff recruitment, development, and performance. **As a Senior Manager , a typical day may include:** **Study Oversight** :...Compliance** : + Review and approve study documents (eg, Data Management Plans, Validation Specs). + Ensure… more
