- Merck & Co. (North Wales, PA)
- …Responsibilities: Responsible for the operational planning, feasibility, and execution of a clinical trial .May serve as the clinical trial team leadMay lead team ... planning, development, and execution elements (eg, data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates,… more
- Merck & Co. (Rahway, NJ)
- …across the full c ompany's Research & Development Division portfolio of clinical trial s .- GCS is accountable for the planning, sourcing, labeling, packaging and ... the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities… more
- Genmab (NJ)
- …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 compound ... lead, primarily up until proof of concept, and/or as trial responsible statistician.Responsibilities:Compound/Indication LevelAct as lead and main point of contact… more
- Merck & Co. (Rahway, NJ)
- …Management Section of the GCS Planning organization. -Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic ... activities include, but are not limited to:-Participates on the Clinical Trial Team (CTT) and collaborates closely with other functional area representatives… more
- Genmab (NJ)
- …indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below. The Associate Director ... courses and perform professional networkingEngage with regulatory authorities on trial level discussionsArranges/attends lessons learned to share learningsRepresents Genmab… more
- Merck & Co. (North Wales, PA)
- …for the operational planning, feasibility, execution and conduct of clinical trial (s).Serves as the Clinical Trial Team lead. Leads and ... subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.Liaises with partners, vendors, and vendor management team . Review… more
- Merck & Co. (North Wales, PA)
- …This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical ... study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment… more
- Merck & Co. (Rahway, NJ)
- …chain across the full Company's Research & Development Division portfolio of clinical trial s .- GCS is accountable for the planning, sourcing, labeling, packaging ... arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact… more
- Merck & Co. (San Francisco, CA)
- …the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project Manager will streamline the execution of our Company's DSCS Digital Strategy to ... robustness across organizational deliverables.- In this role, the DSCS Digital Project Manager will provide tactical direction and partner with the DSCS Digital… more
- Merck & Co. (Rahway, NJ)
- …This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team in review and interpretation -of clinical ... (e . g . , ICF documents/ amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data collection in alignment with… more
- Genmab (NJ)
- …integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our science through compelling clinical ... of regulatory submissions (eg, NDA, BLA, MAA).Drive collaboration with cross-functional trial teams to manage timelines, facilitate meetings, and lead review… more
- Genmab (NJ)
- …would love to have you join us!Responsibilities:Lead programmer for a trial (s)Review CRFs for adequacy and consistencySupport establishment and maintenance of Genmab ... SDTM and ADaM database standardsDrive development of programming specificationsDrive consistency across trialsResponsible for keeping proper documentation and filing to eTMFProvide sponsor oversight of vendor programming activitiesSupport in-house production… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring integrity, consistency and adherence ... of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety,...Practical knowledge and experience using R to support clinical trial analyses.For US based candidates, the proposed salary band… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities ... Document (CTD), Clinical Study Report (CSR) and Nonclinical Study Report (NCR), electronic Trial Master File (eTMF) and other pivotal documents to be submitted to… more
- Novo Nordisk Inc. (Orlando, FL)
- …improved patient health. Internally, the EDCS reports to the Endocrinology District Business Manager of the specific sales territory. The EDCS interacts on a regular ... and the appropriate patients that would benefit in order to ensure early trial and utilization Generate advocacy for Novo Nordisk products and services by sharing… more
- Novo Nordisk Inc. (Walnut Creek, CA)
- …the Specialty Field Sales Representative reports to the District Business Manager of the specific sales territory. The Specialty Field Sales Representative ... and the appropriate patients that would benefit in order to ensure early trial and utilization Generates advocacy for Novo Nordisk products and services by sharing… more
- Merck & Co. (North Wales, PA)
- …skills, expertise in leading large teams in the development of novel clinical trial designs and analysis methods in oncology, experience in directing multiple teams ... submissionsDemonstrated history of development and execution of innovative clinical trial designs and exploration of novel analysis methods in...and maintaining high performing teams both as a direct manager and a second line manager (ie,… more
- Formation Bio (New York, NY)
- …development programs at Formation Bio. This role requires an experienced program manager who can oversee at least one drug development program, managing multiple ... execution, ensuring the team stays at the forefront of innovation in clinical trial operations. About You You're excited about the intersection of AI and program… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for the management, ... technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements & ... Leads US FDA/EU EMA interactions with support from higher-level manager .Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory guidances. Serves… more
