- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership ... and overall strategic oversight of study management and delivery for all therapeutic...with Asset and Portfolio Management (APM), GCO Clinical Trial Business Operations (CTBO), and GCO Study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... regulatory compliance, and patient safety related to managing assigned clinical trials, document management and management...of systems, eg, CTMS, eTMF and set up of study email/mailboxes Identification of problems in relation to tasks… more
- Tris Pharma (Monmouth Junction, NJ)
- …cross functional collaboration to develop program strategy and the implementation of clinical study processes and procedures ensuring timely execution of quality ... in identification and evaluation of potential investigators and other service vendors performing clinical study work May also function as a Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Domestic and international clinical trial execution experience required Post-approval clinical management experience a plus Direct management experience ... Position This leadership position is accountable for resourcing, development, training and management of a highly performing Clinical Operations team. The… more
- Merck & Co. (Rahway, NJ)
- …aid in transfer of electronic data files into the Clinical Data Management System (CDMS). Interface with members of study teams, including external ... aid in transfer of electronic data files into the Clinical Data Management System (CDMS). Leads and...CROs/Vendors where applicable, to integrate study team requirements into all deliverables. Leads and participates… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategic documents, including NNI Evidence Generation Plans and Product Development Plans Clinical study management : Provide regional medical & scientific ... Position Use medical and clinical expertise in design, implementation and monitoring of clinical studies (from Phase 1 to 4) in a team setting. Provide… more
- Novo Nordisk Inc. (Atlanta, GA)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical activities as appropriate.Responsibilities Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... Ensure the global clinical operations systems for management of company sponsored studies review and...and approvals are current and accurate.Liaison and reporting on study activities with other relevant GOMA functions and the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …establishing data collection, data standards and data cleaning needs for DS Programs / Studies .Serve as the subject matter expert for Study Data Managers during ... Management :Provides guidance for collection of all external data management deliverables for assigned DS Program / Studies...to support the collection of diverse external data types.Advises Study Data Manager on complex vendor management … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and represents function to standards team as an extended part of committee. Advise Study Data Manager on complex vendor management issues and provides guidance ... and SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical company,… more
- Merck & Co. (Rahway, NJ)
- …of Clinical Trial Research Agreements (CTRA).Oversees and tracks clinical research-related payments. Payment reconciliation at study closeout. Oversees ... oversight to local vendors as applicable.Oversees and coordinates local processes, clinical and ancillary supplies management , importing and exporting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …resolve or escalate to appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve or ... clin pharm patient studies , and Phases 1-3 clinical trials at the study and program...Clinical Operations on plans for successful implementation of studies . Responsible for management of compounds at… 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 ... International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …provide safety leadership including but not limited to clinical studies , post-marketing surveillance, signal detection and management , important safety ... represent the CSPV on the Global Product Team or specific sub-teams such as clinical study team and submission team, providing the safety leadership and serving… 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 ... International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development and control of Clinical Project Budget in support of Phase I-III clinical studies . Partner with Project Management , Clinical Operations ... planning, internal reporting, ad hoc reporting and analysis, and change management initiatives. Also responsible for expense or headcount control procedures and… more
- Tris Pharma (Monmouth Junction, NJ)
- …colleagues, the incumbent contributes to the design, data collection and reporting of clinical studies in a manner consistent with industry standards, applicable ... documents, Investigational New Drug (IND) annual reports, Investigator's Brochures, clinical study reports and scientific presentations including abstracts,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management , the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... pertaining to clinical trials, including but not limited to: data management tool and system development, validation and maintenance, data integrity review and… more
- Merck & Co. (North Wales, PA)
- …for Research & Development (R&D) projects (data, analyses, tables, graphics, listings). Clinical Data Interchange Standards Consortium (CDISC), Study Data ... assurance of deliverable quality and process compliance.Familiarity with statistics and clinical data management concepts. Preferred Experience and Skills:Strong… more
- Insmed Incorporated (Bridgewater, NJ)
- … methodology, protocol design, project management and regulatory requirements for clinical studies .Must have a global perspective and mindset, with the ... by working closely with Clinical Scientists and Clinical Operations personnel on clinical studies...needed.Collaborate with team and CROs to prepare and finalize clinical study protocols, associated amendments and Special… more
