- Merck & Co. (North Wales, PA)
- …Education :- Bachelor's degree with at least nine (9) years of pharmaceutical, clinical drug development, project management and/or medical field experience. ... degree with at least (six) 6 years of pharmaceutical, clinical drug development, project management and/or medical field experience.OrPhD/PharmD degree with… more
- Merck & Co. (North Wales, PA)
- …knowledge of- statistical and data processing software eg SAS and/or R.-Good project management skills. --Good understanding of worldwide regulatory requirements ... and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment,… more
- Novo Nordisk Inc. (Nashville, TN)
- …strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities Study Strategy: Provides ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and control of Clinical Project Budget in support of Phase I-III clinical studies. Partner with Project Management , Clinical Operations and other ... process. Coordination with all functional areas impacted including Legal, Procurement, Project Management and Commercial or Corporate Finance, Operations.… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related ... Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management ;… more
- Insmed Incorporated (Bridgewater, NJ)
- …and Best Workplaces for Millennials™ lists.OverviewAssist in the delivery of Clinical Operations objectives by providing operational support to the clinical ... study team (CST) with the responsibility to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ICH guidelines,… more
- Merck & Co. (North Wales, PA)
- …and translation vendors.Support implementation of COA measures in connection with our company clinical trials through strong project management and timely ... clinical outcome assessment licensing and translations agreement negotiationProject management experience and/or certificationGood Clinical Practice certification/training#EligibleforERP… more
- Merck & Co. (North Wales, PA)
- …cross-functional team. You will build and coach your team in the development of project management , communication, and collaboration skills in support of our ... support of clinical trial objectives.Liaises with partners, vendors, and vendor management team.Review and provide clinical operations input into relevant … more
- Merck & Co. (North Wales, PA)
- …the leadership level including the development of electronic submission deliverables.Strong project management skills; A program leader; Determines appropriate ... systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and inspections. Finally, this position has strong skills in continuous improvement, project management , change management , and risk management ... for a larger number of projects/studies with greater complexity.May manage Data Management full-time and/or contract staff. Project Management :Plans and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …within Clinical OperationsDevelop risk assessment & risk management and clinical project management competencies within Clinical OperationsWork ... will require line management responsibility of Directors, Associate Directors, Clinical Study Managers, who are...leadership to Clinical Operations staff and to project teams for Vendor evaluation, selection , management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ... on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams...teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance… more
- Merck & Co. (North Wales, PA)
- …research & development (R&D) projects (data, analyses, tables, graphics, listings).Strong project management skills; leadership at a program level; determines ... to be programmed; an understanding of statistical terminology and concepts.Familiarity with clinical data management concepts.Hands on experience in CDISC and… more
- Merck & Co. (North Wales, PA)
- …thought leaders, US policy/ advocacy stakeholders or US market access. Strong project management skills as demonstrated by prioritizing activities, using ... Job DescriptionThe Associate Director will report directly to the US...work across the enterprise to define value evidence and clinical development needs to support US commercial forecasts. As… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …required- Industry experience: Pharmaceutical, life science, clinical trials management , healthcare preferred- Project Management Professional (PMP) ... contingent workers. Identify new capabilities within functions.- Execute with strong project management skills, including monitoring work-plans and managing… more
- Merck & Co. (Rahway, NJ)
- …Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management , Software Development, Stakeholder Relationship ManagementPreferred ... Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global... Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development… more
- Merck & Co. (North Wales, PA)
- …able to convert complex ideas and information into simple readable form.Strong project management skills; Manage at a program level; influences approach/s ... assurance of deliverable quality and process compliance.Familiarity with statistics and clinical data management concepts. Preferred Experience and Skills:Strong… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …have demonstrated ability to formally plan, execute, and deliver projectsMust have Project Management experience Licenses and CertificationsIf degree is outside ... and expertise. Finally, this position makes tactical decisions utilizing input from upper management that impacts more than one project team at a time.… more
- Merck & Co. (Rahway, NJ)
- …individual to work in a fast-paced job that provides both technical and project management responsibility. The Associate Specialist - Manufacturing ... production, utility systems and associated infrastructure.- Responsibilities of the Associate Specialist - Manufacturing Automation include the following: Small… more
