- 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
- ThermoFisher Scientific (Lawrenceville, NJ)
- …decisions._ **Knowledge, Skills, Abilities** + Demonstrated clinical trial experience, healthcare/medical/laboratory or equivalent. + Vendor experience ... clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy… more
- Bristol Myers Squibb (Princeton, NJ)
- …development projects. Efficiently plan, coordinate, and deliver complete, high quality and reliable clinical trial data in a timely manner for assigned projects. ... more: careers.bms.com/working-with-us . Employer: Bristol-Myers Squibb Company Job Title: Senior Manager , Clinical Data Management (ref.# 4488) Job Location:… 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 (New York, NY)
- …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
- Bristol Myers Squibb (Princeton, NJ)
- …expertise, good working knowledge of Pharmaceutical R&D business processes, particularly in Clinical Trial Operations, with demonstrated command of key concepts, ... enable Global Development Operations (GDO), specifically focusing on Veeva Clinical Vault (Veeva CTMS, Veeva eTMF). This role, under...for time sensitive support tickets + Work with the vendor for any major issues/bugs in the applications +… 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
- Bristol Myers Squibb (Princeton, NJ)
- …CLIA, data management, risk management, and regulatory issues. + Demonstrated clinical trial experience in healthcare/medical/laboratory settings or equivalent. ... samples, loading documents to Shared Drive folders, etc.). + Independently reviews clinical study protocol providing comparison of vendor statement of work… more
- Actalent (Princeton, NJ)
- …to the client's outsourcing strategies within specific therapeutic areas. The role supports clinical trial vendor partnerships across select or multiple ... Outsourcing Manager Job Description This individual contributor role has...service categories of clinical trial activities in R&D. Key Responsibilities:… 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 (Princeton, 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
- Novo Nordisk (Plainsboro, NJ)
- …provides US market access input to Global and US stakeholders to inform clinical trial programs, guide evidence generation development, payer value stories, and ... of cell therapy reimbursement. Shape the payer value story, supported by credible clinical , health economics and quality of life messages as the market and the… more