- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …etc. + Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + ... Ensures compliance with the clinical trial registry requirements + Identifies outsourcing...collaborations + Applies advanced negotiation and interpersonal skills to vendor management + Advanced technical proficiency in trial… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …the CRO and the study team. Oversee the site qualification process. + Monitor clinical trial performance and quality metrics and share with study team, ... Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key… more
- Abbott (New York, NY)
- …initiatives. The Clinical Lead Specialist is to support Abbott TAVI US clinical trial and commercial case coverage, trial enrollment and sales ... in collaboration with the Regional Sales Directors and the Clinical Lead Manager (CLM). This position will...proper patient selection. + Serving as primary resource for clinical trial and lead/coach/commercial case support, demonstrating… more
- Pfizer (Parsippany, NJ)
- …data set release and consistency in asset/submission data. **KEY RESPONSIBILITIES** + Serve as Clinical Data Scientist and Trial Lead for one or more clinical ... discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and...+ Ensure the required study-specific CDS documents in the Trial Master File (TMF) are of high quality and… more
- Pfizer (New York, NY)
- …of consistent, efficient, and quality processes to meet timelines and deliverables. + Serve as Clinical Data Scientist and Trial Lead for one or more clinical ... and vendor oversight experience + Proficient in using commercial clinical data management systems and/or EDC products Work Location Assignment:On Premise The… more
- System One (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within...other vendor performance against project goals and milestones to monitor… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Program Operations Leader and Clinical Study Lead(s) for one or more assigned clinical programs within Clinical Trial Management. The role is responsible ... and organization for GCP inspections with a focus on clinical trial management activities for assigned programs...of the inspection readiness activities. + Work with the Clinical Study Leads, CRO and/or Vendor team(s)… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development ... the collection of diverse external data types.Advises Study Data Manager on complex vendor management issues and...disease therapeutic area is a must. Working knowledge of Clinical trial data systems and/or EDC and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Excellent time management skills preferred. + Experience with PH.1 - PH. IV clinical trial vendor contracts required. + Experience with CRO contracts ... preferably in Life Sciences required Experience Qualifications + 4 or More Years in clinical trial outsourcing, health sciences or related field ( clinical … more
- Bristol Myers Squibb (New Brunswick, NJ)
- …+ Generates internal packaging and labeling production orders in accordance with the clinical trial design and all relevant regulatory requirements for assigned ... effective management of assigned projects. Manages multiple projects. Liaise with responsible Trial Supply Managers on aspects of clinical supplies packaging and… more
- IQVIA (Parsippany, NJ)
- Job Overview Project Management Analysts (PMA) are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by ... The PMA works in partnership with the Project Leader (PL)/ Clinical Project Manager (CPM) providing support with...Knowledge of clinical trials - knowledge of clinical trial conduct and skill in applying… more
- AbbVie (Florham Park, NJ)
- …research, scientific presentations and publications for all therapeutic areas, vendor oversight of study executions, RWE methodology research, evidence evaluations ... + Provide statistical expertise for design, analysis and reporting of clinical or scientific research studies or programs and contribute to development… more
- Bristol Myers Squibb (Madison, NJ)
- …ensuring alignment with Bristol-Myers Squibb's (BMS) outsourcing strategies. The role supports vendor partnerships across various clinical trial service ... is a plus). + 3 to 5 years of clinical development experience in the pharmaceutical, biotech, or CRO...managing a variety of suppliers, including Contract Research Organizations, clinical laboratories, and service providers, with the ability to… more
- Publicis Groupe (New York, NY)
- …agencies specializing in promoting innovative solutions in advertising, medical education, clinical trial program development, sales and marketing, digital, ... a global leader. **Job Description** CoLab Publicis Health is seeking a **Senior Program Manager ** to join a robust team who are leading our clients to new… more
- Hackensack Meridian Health (Edison, NJ)
- …collection and organization of due diligence for Closings, Litigation and Financings. + Clinical Trial Support: Assists with the review, revision and negotiation ... Contract Maintenance Support: Assists in the administration of Tract Manager . Assists in the administration of Tract Manager...of Clinical Trial Agreements. Reviews, revises and negotiates… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**NOTE: This Project Lead Role is an Individual Contributor and sits at the Manager Grade level.** This position is responsible for enabling the on-time delivery of ... clinical supplies across the DSI portfolio. This role as...products with approved vendors and obtains required documentation. + Vendor Management -supports Person in Plant (PIP) activities when… more