- 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)
- …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)
- …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 ... for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary supplies planning /tracking, lab specimen tracking,… more
- Merck & Co. (Rahway, NJ)
- …have specific operational responsibilities for a single study or across multiple studies (e. g . , operational deliverables, clinical & ancillary supplies ... Job Description Job Summary This position contributes to the operational planning and execution of one or more clinical trials. In this position, you will have… 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)
- …serve as the clinical trial team leadMay lead team in key study planning , development, and execution elements (eg, data management-deliverables, trial level ... Job Description Job Summary: This position leads the operational planning and execution of one or more clinical...study team, country-teams, vendors, committees) in support of clinical study objectives.Accountable for managing any … 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)
- …position drives scientific planning , strategy and execution of Phase 1-4 clinical studies .-Under the direction of the Program Lead, you will collaborate ... with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the set up… 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 ...without degree) Knowledge and Skills: Self-motivated, excellent in work planning and time management. Fluent oral and written English… 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...in a mindset of being a learning organization. Strategic Planning and Oversight:Support strategies to work with GCO and… more
- Merck & Co. (Rahway, NJ)
- …run by partners, and 300+ company Investigator Initiated Studies (IIS) clinical trials. GCS is accountable for the planning , sourcing, labeling, packaging, ... impact today.--Overview:-- -Merck Research Lab's (MRL) Pharmaceutical Sciences & Clinical Supplies (PSCS) organization is responsible for translating a therapeutic… 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 ... Manages mutually beneficial relationships with external partners relevant to the planning and implementation of clinical trials and improvement/innovation… 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 ... study teams to support all relevant Governance and planning meetings.Support engagements with program and study ...reaches out and build relationship with key program and study staff at clinical development and operational… 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
- Aequor (Thousand Oaks, CA)
- …include: ? Translate Toxicology, Pharmacokinetics and Drug Metabolism (PKDM) and Clinical Development study requirements into an actionable supply plan. ... and timing are understood. ? Serve as the primary interface with Clinical Development, Quality, Biostatistics, Regulatory Affairs, Corporate Planning , and… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Affairs point to identify investigators/sites and risks to trial planning and execution KOL and Association Engagement Assist Senior… more
- Merck & Co. (Rahway, NJ)
- … planning , design, and execution of validation procedures and studies . Actively participate to achieve program deliverables.Interface with site engineering and ... continuity.The FLEx sterile area supports the formulation and filling of clinical , stability, and developmental supplies for biologics and vaccines, including… more
- Novo Nordisk Inc. (Oklahoma City, OK)
- …NNI and competitor products Demonstrates thorough knowledge of all promoted NNI approved clinical studies and the skill to engage customers (prescribers, support ... current co-promotion partners. Internally, the DCS reports to the District Business Manager of the specific sales territory. The DCS also interacts and collaborates… more
