- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President, Global Data Management & Standards (GDMS) is responsible for ensuring that all clinical data management ... system (IVRS) services, ePRO services, pharmacovigilance case processing, data standards and platform governance. Primary Responsibilities: Ensures Clinical … more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution ... Global review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This ... compliance across clinical study safety reporting and activities. Global Clinical Study Start-Up Documentation: Reviews all...the project and/or study level as it relates to data capture and reporting. Establishes EDC standards … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in one or more of the following is preferred: Market Research, Data & Analytics, Clinical OperationsPharmaceutical industry experience helpful, but not ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. Responsibilities:Study Strategy: Clinical study leader ... TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... 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. (Bernards, NJ)
- …stakeholders including members of Global Companion Diagnostics, Translational Sciences, Global Clinical Operations, Biostats and Data Management and ... diagnostics development and implementation of biomarker assays in support of multi-site global clinical trials is preferred. Competencies Understanding of the… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …preferred4 or More Years experience in pharma at local, regional and/or Global level. preferredExcellent knowledge of current clinical practice in Oncology ... 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. (Bernards, NJ)
- …opportunities in order to support best in class sourcing and procurement for Global RD - for their specific categories.- Data Analysis Based Decision-Making- ... of clinical trials preferred- Demonstrated ability to leverage digital data and analytics preferred- Demonstrated ability driving or participating in digital… more
- Merck & Co. (Upper Gwynedd, PA)
- …results-oriented project management skills Preferred Experience and Skills: At least 5 years global or US medical affairs or clinical development experience with ... Job DescriptionThe Executive Director, Global Medical and Scientific Affairs (EDMA) GYN Malignancies...Brand and V&I Outcome Research Team leads to define clinical development plans and brand strategies for assigned TAsProvides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …architects and digital technology teams to support data stewardship and governance processes, data cataloging data standards , data quality, and ... management.- Develop and implement strategies for cleansing and standardizing data , with a focus on eg, clinical ,...issue identification, support mitigation, the development and implementation of data quality standards and data … more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan- Accountable ... Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing...Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory documents from the translational perspective. Provide translational deliverables (eg data , reports, and communications) to the Global Project Team ... 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. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) ... 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. (Bernards, NJ)
- …Reviews documents and responses submitted to health authorities globally with respect to data standards , compliance, etc. May represents the function at health ... outputs are compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer's guides, etc.- Global ...and processes. Leads the development and refinement of analysis data standards for AML as well as… more
