- 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 ... are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a ...to identify and incorporate global operational issues into the study design.Execute and trigger communications and escalations at the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical activities as appropriate.Responsibilities Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... clinical operations systems for management of company sponsored studies review and approvals are current and accurate.Liaison and...key activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with ... Operations on SDV plan. Performs literature review and creates reference list for study . Study Planning: Contributes to clinical trial planning including… more
- Merck & Co. (Rahway, NJ)
- …of Clinical Trial Research Agreements (CTRA).Oversees and tracks clinical research-related payments. Payment reconciliation at study closeout. Oversees ... quality standards and adverse event reporting requirements internally and externally.Our Clinical Research and Pharmacovigilance team push the boundaries of global… 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 ... cross- functional team-members including clinical directors and study managers to lead /support clinical ...Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates… 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 ... of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical...to support the collection of diverse external data types.Advises Study Data Manager on complex vendor management… 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
- Merck & Co. (North Wales, PA)
- …relationships with both internal and external groups. The Associate Director Pub Manager is expected to: Lead cross-functional Publication Teams for a number ... least 2 years of experience in publication managementUnderstanding of the clinical development process andclinical study data for assigned… more
- Aequor (Thousand Oaks, CA)
- …or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, ... FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will...Protocol Amendments, Informed Consent Forms, Table of All Studies , Clinical Overview Addenda, eCTD Module 2… 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 complex ... disabilities.SummaryThis position supports early phase oncology development and leads complex studies in study design, statistical analysis and interpretation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as ... of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and...standards team as an extended part of committee. Advise Study Data Manager on complex vendor management… 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 complex ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... role will consist of these components including: Expand and lead our Data Stewardship Working Group (DSWG) across functional...cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify… more
- Aequor (Thousand Oaks, CA)
- …global regulatory standards. Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of ... RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications) Lead study timelines for regulatory documents and regulatory submission… 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 ... Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator… more
- Catalent (Philadelphia, PA)
- …every patient, consumer, and Catalent employee. The Role Support activities of the Manager , Training Program and the Training Lead .Cross train with Quality ... located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, ... global functions including but not limited to Commercial, Marketing, Medical, Clinical Development, Public & Government Affairs.Responsibilities- Lead the… more
- The University of Vermont Health Network (Berlin, VT)
- …working in the Radiology Department. POSITION SUMMARYAt the administrative direction of the Director/ Manager / Team Lead , and the clinical direction of the ... Radiologist, our Certified Nuclear Technologist:Perform diagnostic studies utilizing radiopharmaceuticals and imaging equipment with minimum supervision.Assay and… more
- Merck (Rahway, NJ)
- **Job Description** Under the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data ... not limited to:** + All responsibilities of a Senior Clinical Data Manager (SCDM) and a ...to identify and incorporate global operational issues into the study design. + Execute and trigger communications and escalations… more
- University of Utah (Salt Lake City, UT)
- …Date** **Open Until Filled** Yes **Job Summary** This position is primarily a study lead Clinical Data Manager . The position will be assigned to the Salt ... 1. Participate in the cross-functional project teams as the lead clinical data manager . 2....new or modified study specific processes. The Clinical Data Manager II is expected to… more
