- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … clinical data standards framework. + Define, manage, and govern clinical data standards ; Global Libraries, Standards Packages, Reporting ... employer including veterans and people with disabilities. **Summary** The Associate Director, Clinical Data Standards , is responsible for the development,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …more clinical stage assets (including those at the pre-IND stage) within the Global Clinical Science function. This position may be at the executive director ... high quality clinical trial protocols, review of clinical data and Clinical Study...and safety monitoring under direct guidance of a physician ( Global Clinical Leader or Physician Scientist). The… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best practices), ensures efficient ... head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations, Data Management, Scientific Operations etc) and external… more
- Merck (Rahway, NJ)
- …portfolio. The Global Clinical Operations (GDO) department in housed in Clinical Data Management and Standards (GDMS) within the GCTO organization. ... curious, join us-and start making your impact today. **Overview:** Global Clinical Trail Operations (GCTO) is a...activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards . This position has a ... working knowledge of Electronic Data Capture/related applications and industry standards , and...party vendors to ensure compliance with the protocol, external/internal standards , Good Clinical Practices (GCPs), applicable regulatory… more
- Rockefeller University (New York, NY)
- …regarding the clinical research study + Collect and process research data and specimens as needed/required + Provide assessment skills and direct nursing care ... of both the virus and our antibodies. Overview The Clinical Research Nurse will be responsible for coordinating and...through the development or updating of protocols, procedures, and standards for a study in collaboration with the primary… more
- Actalent (Basking Ridge, NJ)
- This large, leading pharmaceutical is looking to hire a fully remote Senior Clinical Data Manager to their team of subject matter experts! Description: ... Clinical Data Manager who will work collaboratively...according to company SOPs and in compliance with Company's data standards . + Serve as primary DM… more
- J&J Family of Companies (Raritan, NJ)
- Director, Global Real World Evidence (RWE) - Data Science Analytics - 2406196332W **Description** Johnson & Johnson Innovative Medicine is currently seeking a ... **Director, Global Real World Evidence (RWE) - Data ...application + Show leadership on project teams and set standards of excellence for the team by demonstrating professional… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data standards , data quality rules and data governance ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi... data governance activities (eg developing and implementing data standards ) + 3 or more years'… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/she will be responsible for managing the multiple ... (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus...in Clinical Development, Asset & Portfolio Management, Global Clinical Operations, BDM and DLT members.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Working knowledge of key global laws, regulations and guidelines relating to clinical trial documents and data disclosure is desirable. preferred + Good ... WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations...prompt and thorough review of requests for de-identified company clinical trial data . + Ensure company … more
- Taiho Oncology (Princeton, NJ)
- … Clinical Operations in a dynamic, supportive, collaborative and global cross-functional environment. Position Summary: Under minimal supervision, leads and ... manages multiple complex global studies to support the Clinical Development...the preparation of protocols and Case Report Forms (eCRFs), data management, monitoring, communication, and other project plans. +… more
- Merck (Rahway, NJ)
- …heavily relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards , Trial Design, Trial Data Collections, Trial ... trial participants, in the right way to enable the Clinical Research to analyze data for efficacy,...first site ready. + Remove obstacles and enable the Global Clinical Trial Organization to focus on… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Stryker (New York, NY)
- …of real-world data sources as an essential part of the clinical evidence generation strategy for Stryker's product portfolio. This role involves managing ... are essential for effectively leading RWE initiatives in the company. + Develop clinical strategy and data collection strategy to support new product launches… more
- J&J Family of Companies (Skillman, NJ)
- …+ Utilize scientific analysis principles to facilitate an understanding of product testing and clinical trial data for Skin Health and Hair Care products. + ... Sr Scientist SH Claims Clinical - 2407021764W **Description** Kenvue is currently recruiting...Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse… more
- Taiho Oncology (Princeton, NJ)
- … Clinical Operations in a dynamic, supportive, collaborative, and global cross-functional environment. Position Summary: Under minimal supervision, leads and ... manages complex global studies to support the Clinical Development...randomization processes, if applicable, and subsequent efficient and effective data management. + Ensure compliance with and adherence to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. **Responsibilities** + Study Strategy: Clinical study ... TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Actalent (New York, NY)
- …Ensure compliance with regulatory guidelines, Good Clinical Practice (GCP) standards , and study protocols related to data management activities. + ... plays a pivotal role in ensuring accurate and timely data management for clinical trials. This role...Experience Level: Expert Level About Actalent Actalent is a global leader in engineering and sciences services and talent… more