- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position ... and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …according to the timeline, budget and objectives set forth by the Study team.The Clinical Study Manager role is primarily a tactical study delivery ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...in accordance with DS standards. Act as the project manager of the clinical study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …into individual career development plan.Assist in planning and execution of clinical studies , under the close supervision of a Manager (or above) within ... to the TMFConfirm Essential Document Listing accuracy throughout duration of trialProvide clinical administrative support to the study teams. This may include… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...university)- Bachelor's Degree (preferred in Life Sciences) with relevant clinical development experience requiredExperience Qualifications- 2 or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …metrics, and provide this feedback through regularly scheduled 1:1 meetingsCollaborate with Clinical Study Manager on SA deliverablesParticipates in ... who assist in planning and in the execution of clinical studies in adherence to the protocol,...International Conference on Harmonization (ICH) guidelines.The Manager , Study Associates will ensure the SAs provide clinical… more
- Merck & Co. (Rahway, NJ)
- …progressive on-the-job training and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your Fellowship ... for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary...beyond CSSM Exposure to Senior level positions within the clinical development forum Hands-on experience in the… more
- Merck & Co. (North Wales, PA)
- …operational responsibilities for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary supplies planning/tracking, ... expertise with team members.May interact with internal and external stakeholders (eg, study team, vendors, committees) in support of clinical trial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to applicable Daiichi Sankyo and regulatory requirements. Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management ... operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies within...Plan, Clinical Study Reports).Leads and drives the data review process in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical ... as a project manager for other activities involving assigned product(s) or clinical studies , as needed Qualifications: Successful candidates will be able to… more
- Merck & Co. (Rahway, NJ)
- …Lead Clinical Scientist and study team with the scientific conduct of clinical studies . In this position, you will have the opportunity to develop your ... for specific clinical /scientific activities on a single study or across multiple studies (eg, medical...and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... during and post- regulatory agency sponsor inspection with the goal to ensure GCO/ clinical teams are prepared and trained and study documentation is quality… more
- Merck & Co. (Rahway, NJ)
- …external stakeholders ( study sites, vendors, committees, etc.) in support of clinical study objectives.--You will be part of a diverse, cross-functional team ... activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical ...Trial Operations Exposure to Senior level positions within the clinical development Hands-on experience in the conduct… more
- Merck & Co. (Rahway, NJ)
- …in-house, 400+ outsourced or run by partners, and 300+ company Investigator Initiated Studies (IIS) clinical trials. GCS is accountable for the planning, ... transitioning service members a unique opportunity to gain valuable professional experience through our 12-week fellowship program.--During your fellowship with our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium ... and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design,… more
- Novo Nordisk Inc. (WA)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... Washington DC or Baltimore, MD. Qualifications A minimum of 4 years of clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is required Experience Qualifications4 or More Years clinical operations experience with strong preference for study feasibility, and/or study design ... study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational feasibility… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies , Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for ... submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred Experience Qualifications- Eight (8) plus years of pharmaceutical experience in clinical development and the pharmaceutical industry with ... culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical conduct of...involvement in a regulated GCP environment or equivalent experience preferred- Experience in Clinical … more
- ProKatchers (Raleigh, NC)
- …the technology suite for clinical studies . * Full awareness of the clinical study pipeline, connecting with clinical study teams. * Deliver ... Job Description: * Responsible for understanding the specific study requirements (software, devices, etc ) associated with...functional scope of the app (which eCOAs, what patient experience , UX, other features part of the product(s)) in… more
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