- Insmed Incorporated (NJ)
- …aspects of clinical operations, project management, the drug development process, and clinical trial conduct, including systems and procedures, as well as the ... regulations and requirements governing such conduct (including, but not limited to, ICH / GCP and regulatory requirements).Experience managing staff and providing oversight of department activitiesEffectively oversees, manages, and influences CROs and… more
- Genmab (NJ)
- …compound lead, primarily up until proof of concept, and/or as trial responsible statistician.ResponsibilitiesCompound/Indication LevelAct as lead and main point of ... courses and perform professional networkingEngage with regulatory authorities on trial level discussionsArranges/attends lessons learned to share learningsRepresents Genmab… more
- Merck & Co. (Rahway, NJ)
- …trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.Experience leading large and/or complex statistical ... field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering… more
- Eisai, Inc (Oklahoma City, OK)
- …leaders, medical groups, government agencies, key opinion leaders and health systems with drug formularies, consumer-ready medical and dental products. Educates and ... professions, public, and government. Explores and identifies sites for clinical trial in all stages of development. Coordinates continuing education workshops,… more
- Merck & Co. (Rahway, NJ)
- …Research Associate (CRAs), Clinical Research Managers (CRMs), -in the Global Clinical Trial Operations (GCTO) Regions in alignment with strategic priorities for the ... This role focuses on creating role-based, therapeutic area-specific, and process and system training materials and delivering them through live, virtual, or recorded… more
- Merck & Co. (North Wales, PA)
- …trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertiseDesigns and develops complex programming algorithmsAbility ... field plus 5 years SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering… more
- Eisai, Inc (Baltimore, MD)
- …which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies statistical theories, methods, and ... and approval of the experimental therapies. May partner in trial design and in establishing standards for clinical conduct,...Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in… more
- Merck & Co. (North Wales, PA)
- …field plus 5 years SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... field plus 3 years SAS programming experience in a clinical trial environment Department Required Skills and Experience: Excellent communication (oral, written)… more
- Merck & Co. (North Wales, PA)
- …field plus 5-9 years SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... related field plus 3-7 years SAS programming experience in a clinical trial environment Department Required Skills and Experience: Effective interpersonal skills and… more
- Genmab (NJ)
- …ultimate objective of data quality and consistency across programs and systems . Responsibilities Develops and implements company Study Data Tabulation Model (SDTM) ... of SDTM standards with data collection standards and relevant company tools/ system requirements by reviewing study eCRFs, supporting creation of external data… more
- Merck & Co. (Rahway, NJ)
- …as noncompartmental analysis, population pharmacokinetic, exposure-response, quantitative system pharmacology, viral dynamics, model-based meta-analysis, and other ... model-based analysesPerform clinical trial simulations to inform dose selection and go/no-go decisionsServe as a QP2 representative while being mentored by QP2… more
- Eisai, Inc (San Francisco, CA)
- …This role offers the opportunity to lead high-impact imaging strategies-from trial design and execution to data interpretation-while driving scientific innovation ... and radiomics) to ensure imaging strategies are optimized for clinical trial design and aligned with scientific objectives.Design and execute exploratory imaging… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …regulatory requirements.Collaborate with cross-functional teams to develop study protocols, analyze trial data, and manage trial progress. Medical Monitoring: ... regulatory frameworks (eg, FDA), GCP guidelines, and quality management systems .Preferred but Not Mandatory: Medical practice experience in respiratory… more
- Merck & Co. (Rahway, NJ)
- …demand pipeline, contribute in Business case creation incorporating input from Business System Owner (BSO) and other stakeholders to ensure alignment with strategic ... Product Management experience supporting Information Technology, Pharmaceutical Research, Clinical Trial Operations or related business areas. Demonstrable experience in… more
- Eisai, Inc (Nutley, NJ)
- …environment. Strong communication skills, executive presence, and proficiency with enterprise systems are essential, along with a proven track record in ... resolution at the relationship level across multiple supplier categories.Clinical Trial Support Oversees global outsourcing activities, and collation of… more
- Eisai, Inc (NJ)
- …outsourcing activities with broader organizational objectives. Proficiency in enterprise systems and a deep understanding of ICH/GCP guidelines and pharmaceutical ... successful business negotiations and issue resolution at the relationship levelClinical Trial Support Directs global outsourcing team and oversees collation of… more
- Novo Nordisk Inc. (Minneapolis, MN)
- …budget expenditures as directed Records all activities within a customer response management system (eg VEEVA) and all expenses within Concur in accordance with FMA ... and development activities in the medical community Collaborates with trial /study investigation sites; ensuring effective coordination and facilitation of studies… more
- Cipla (Fall River, MA)
- …archival of the documents. Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor of necessary improvements in ... (GMP)/Good Documentation Practices (GDP), etc. Technical Knowledge and Computer Systems Skills: Understanding of laboratory equipment operation, qualification and… more
- Cipla (Fall River, MA)
- …archival of the documents. Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor of necessary improvements in ... Practices (GDP), USP monograph requirements. Technical Knowledge and Computer Systems Skills Understanding of laboratory equipment operation, qualification and… more
- Eisai, Inc (Nutley, NJ)
- …should have a good working knowledge of the range of healthcare reimbursement systems and reimbursement guidelines.This position is ideal for a candidate with a ... adaptations of economic modelsIndirect treatment comparisons, network meta analysesPost-hoc trial analysesGlobal value dossiersLiterature reviewsStrategic business functions:Collaborations with other… more
