- 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 ... end Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager (LCDM); issuing queries… 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)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... regulatory agency sponsor inspection with the goal to ensure GCO/ clinical teams are prepared and trained and study...GCO/ clinical teams are prepared and trained and study documentation is quality controlled and available, and all… more
- 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
- 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, ... impact today.--Overview:-- -Merck Research Lab's (MRL) Pharmaceutical Sciences & Clinical Supplies (PSCS) organization is responsible for translating a therapeutic… 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 ... and Strategy:Establishes Data Management strategy at the project and/or study level for a smaller number of projects/ studies...Plan, Clinical Study Reports).Leads and drives the data review process in… 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 ...milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the… 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 ... of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of...for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary… 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
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for ... (GPP) and Standard Operating Procedures (SOPs). Manages several complex activities and study types.Our Clinical Research and Pharmacovigilance team push the… more
- Merck & Co. (North Wales, PA)
- …stakeholders (eg, study team, country-teams, vendors, committees) in support of clinical study objectives.Accountable for managing any study specific ... the clinical trial team leadMay lead team in key study planning, development, and execution elements (eg, data management-deliverables, trial level… more
- Merck & Co. (North Wales, PA)
- …and related study materials (eg, ICF documents/amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data ... Summary: This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational feasibility ... packages.Proactively reaches out and build relationship with key program and study staff at clinical development and operational team levels to drive adoption of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position Leads the execution of observational research studies through the hands-on analysis of real world data...Science, serving as a key contact point into the Clinical Data Science and Evidence (CDSE) Real World Evidence… 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 ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical conduct of interventional, non-interventional, ... Business Unit Strategy globally; promote a quality culture by providing study team support to uphold the ethical conduct of interventional, non-interventional,… 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)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low ... immune disorders.Summary Position leads statistical support for low to medium complexity studies including contributing to development of optimal study design,… more
- Aequor (Thousand Oaks, CA)
- …include: ? Translate Toxicology, Pharmacokinetics and Drug Metabolism (PKDM) and Clinical Development study requirements into an actionable supply plan. ... Remote role - need to work Pacific zone hours Manager would prefer candidates who are local to sit...and budget projections ? Determine distribution strategies for global studies . ? Articulate clinical supply chain management… more
