- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team Leader for the assigned ... disorders.SummaryThe incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence... trial performance and quality metrics and share with study team, Operations Program Lead, and Sr.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... and execution of clinical studies...study budgets.Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides input on… 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 ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...NACD and Novo Nordisk (eg, across NACD, CMR, International Operations (IO), HQ R&D and Commercial). Provides excellent customer… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disciplines and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. ... This position has experience working on Phase I-IV study studies within the medical device and/or pharmaceutical industry across multiple therapeutic areas and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support ... indications.Support as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …MSA discussions of external vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) ... opportunity employer including veterans and people with disabilities. Summary The Associate Director, External Data Management, is accountable for the end-to-end… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaboration: Responsible for implementation of best practices and standards for clinical operations , including sharing lessons learned. Partner closely with ... management, placement and delivery to US and CA warehouses operations for US and CA Clinical Trial.../ device management) Responsible to ensure timely availability of clinical study materials and ancillary supplies to… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies .-Under the direction of the Program Lead, you will ... collaborate with global, cross- functional team-members including clinical directors and study managers to...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Insmed Incorporated (Bridgewater, NJ)
- …related issues.Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations , non- clinical ... organizations etc.) to build and to execute the bioanalytical strategy specific to clinical development programs.Participate in clinical study design and… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, Clinical Operations ...as well as overall day-to-day operations of clinical studies , ensuring study information ... studies and experience multiple facets of Clinical Operations in a dynamic, supportive, collaborative...Associate Director (AD) is responsible for ensuring assigned clinical studies are delivered within timelines, budget,… more
- Actalent (New York, NY)
- …. Bachelor's degree Scientific/health care field preferred. Advanced degree preferred. . Clinical operations experience (8+ years) with evidence of increasing ... Critical thinking and a good understanding of the scientific and clinical components of studies in therapeutic area. . Excellent verbal and written communication… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …for this role. The position can be based in Armonk, NY or Basking Ridge, NJ._ A Clinical Study Associate Manager (CSAM) role supports the Clinical ... sites may be required to assist with monitoring clinical studies . **A typical day as CSAM...as well as experience in clinical trial operations including developing key study documents. We… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... and execution of clinical studies...milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP). **Responsibilities** +… more
- University of Pennsylvania (Philadelphia, PA)
- …Unit (CRU)- Myeloma Research Team and indirectly report to the CRU Central - Associate Director of Clinical Research Operations . The successful candidate ... to develop project plans and support day to day operations of clinical research proposals for their...Specialist, Billing Compliance staff, and Finance office to develop clinical trial budgets. Communicating any specialized study … more
- J&J Family of Companies (Spring House, PA)
- … lead with MM role responsibilities on clinical pharmacology and other ED studies , as needed. + Serves as Global study responsible physician (SRP) and ... (ICF), Case Report Forms (CRF), Top Line Results (TLRs), Clinical Study Reports (CSRs); owner of safety...standard operating procedures. + Regularly surveils/assesses safety in ongoing clinical studies (eg, prepare and archive medical… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …biomarkers, drive the scientific imaging aspects and tumor response assessment of oncology clinical studies . We assume you will be an imaging scientific leader ... The Associate Director, Clinical Imaging will own...implement multi-modality imaging measures as endpoints for oncology therapeutic clinical studies . + Collaborate closely with Regeneron… more
- ThermoFisher Scientific (Bridgewater, NJ)
- …that people and communities depend on - now and in the future. Our global Clinical Operations colleagues within our PPD(R) clinical research services provide ... end-to-end support for clinical trials from study start up to monitoring through to study...clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies . This position requires overnight travel… more
- Merck (North Wales, PA)
- …Description** This position drives scientific planning, strategy and execution of Phase 1-4 clinical studies . Under the direction of the Program Lead, you will ... collaborate with global, cross- functional team members including clinical directors and study managers to lead/support...your employment may pose an undue burden to business operations , in which case you may not be offered… more
