- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DS clinical data standards framework.Define, manage, and govern clinical data standards ; Global Libraries, Standards Packages, ... including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards , is responsible for the development, maintenance,… more
- Eisai, Inc (Nutley, NJ)
- …responsibilities.Ensures the timely and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data , patient ... The incumbent will assume a crucial role within the Global Value & Access (GV&A) team, responsible for leading...statistical methodologies and their application in the context of non- clinical studies and related projects in AD and other… more
- Merck & Co. (Rahway, NJ)
- …portfolio. The Global Clinical Operations (GDO) department in housed in Clinical Data Management and Standards (GDMS) within the GCTO organization. ... 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)
- …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)
- … Inspection Readiness (IR) and pre-approval Inspection preparation activities for global clinical operations, responsible for representing the GCO-CQM inspection ... trial processes and functions including experience in one or more clinical trial operations functions / sub-functions ( Data Management, Biostatistics, … more
- Merck & Co. (Rahway, NJ)
- …and other database capabilities used for review, cleaning and verification activities of clinical data captured in clinical trials and technically implements ... database design and development activities supporting startup of a clinical trial.Activities supported may include standards technical component development… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable for ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… 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 moderate technical skills in working with data received from CROs and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including but not limited to: Global Clinical Operations, Global Regulatory Affairs, Biostatistics and Data Management, Epidemiology, Patient Advocacy, ... Provide input to Therapeutic area leadership as well as Global Clinical leads in the establishment of...(KPIs) to analyze and report on diversity metrics in clinical trials- Monitor data and regularly communicate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated ... and patient voice planning.Maintain relevant and current awareness of the evolving global requirements for diversity in clinical trials -Continually evaluate… more
- Eisai, Inc (Nutley, NJ)
- …strengthen compliance with GDPR, HIPAA, CSL, and other relevant security and data privacy standards . Your responsibilities span security operations, risk ... optimization. Essential Functions: Partnerships and Business Relationships:Promotes awareness of standards related to security, regulatory, clinical , commercial,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …economic models, and Global Value Dossiers- Propose and implement analysis of clinical trial data for cost effectiveness models and market specific ad-hoc ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy: Clinical study leader (CSL) ... TMCP 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)
- …data .Ensure company clinical trial data on the Vivli data sharing and research portal is current.Lead/co-lead global process development and ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs... global laws, regulations and guidelines relating to clinical trial documents and data disclosure is… 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' Experience working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, ... Global Product Team or specific sub-teams such as clinical study team and submission team, providing the safety...as the primary point of contact.- Review and analyze data from clinical trials, post-marketing and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Director, Global Clinical Operations (GCO) Clinical Trial Operational Risk & ... alignment on CRO/Vendor oversight standard practices across GCO and work with Global Clinical Operations, as needed, to understand business priorities.Develop… 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
- 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
