- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Action/Preventive Action (CAPA) plans and related effectiveness measures, as appropriate.Responsibilities: Clinical Trial Operational Risk Management:Own, lead ... around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will be responsible for… more
- Merck & Co. (Rahway, NJ)
- …and SAP team members to further extend capabilities and functionalities on our existing Clinical Trial Supply Management (CTSM) solution in order to satisfy and ... solutions that enable new capabilities and technologies. As the Clinical Supply Delivery Lead for our research...Management and Distribution areas with a strong focus in Clinical Trial Supply Management (CTSM) is highly… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training and/or lessons learned, as appropriate.- Metrics: Support the partnership with Clinical Trial Business Operations (CTBO) to: monitor GCO process ... with minimum of 8 years' experience in pharmaceutical or biotechnology across clinical trial operations. Experience in training, process improvement, and/or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and… more
- Merck & Co. (North Wales, PA)
- …team-members including clinical directors and study managers to lead /support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the ... execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical trial team.Collaborates with the Medical Writer on … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the CRO scope of work in collaboration with Outsourcing Procurement Management. Lead trial feasibility and site identification activities in collaboration with ... and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution requiredStrong experience in procedural writing and life cycle management requiredAdditional clinical trial process experience in one or more key ... other research areas centered around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and… more
- Merck & Co. (Rahway, NJ)
- …non-traditional therapeutics like peptides, novel biological constructs and others, perform clinical trial simulations, comparator modeling and other model-based ... / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding immunology pipeline.As...analyses to inform dose selection and schedule, clinical trial design and go/no-go decisions.- You… more
- Merck & Co. (North Wales, PA)
- …in research activities for innovative statistical methods and applications in clinical trial development.Mentors and guides junior staff in functional ... processing software eg SAS and/or R.-Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.-Strong oral and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …therapeutic modality selection, biomarker characterization and early clinical trial designInteract with, and possibly lead , cross-functional QSP MDT ... which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he/she will develop a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies Target Product Profile (TPP) Development Support: Provide support for clinical trial strategy, regulatory development, and the development of ... on championing alignment across functions, collaborating closely with the clinical team, defining key performance indicators (KPIs), shaping lifecycle strategies,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Data Management and medical coding expertise to promote best practices across the Clinical Trial lifecycle.Applies GCP principles to ensure all medical coding ... end-to-end delivery of medical coding data for assigned projects/studies collaborating with clinical and medical teams, CROs and other vendors to ensure high quality… more
- Genmab (Princeton, NJ)
- …partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports Coordinate data transfers from/to business ... supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible… more
- Genmab (Cranbury, NJ)
- …for automation, design and implement solutions, such as automations for Clinical trial agreements, contract management, site management relates tasks, ... implemented, and utilized at a pace never seen before. Join Genmab as an Associate Director, Intelligent Automation, R&D Digital Products as part of our IT & Digital… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. The Clinical Central Services and Innovation (CCSI) organization is responsible for strategically ... planning and supplying materials, trial support services and innovative capabilities to support the...services and innovative capabilities to support the execution of clinical trials globally for all business units across all… more
- Ascension Health (Carmel, IN)
- …qualifications. Connect with your Talent Advisor for additional specifics._ **Responsibilities** Lead clinical research projects via study protocols and provide ... Ascension St. Vincent is looking for an **RN** - ** Clinical Trial Research Coordinator.** Minimum requirements: The...and Values encompass everything we do at Ascension. Every associate is empowered to give back, volunteer and make… more
- Randstad US (North Chicago, IL)
- …preferably in a health or biological science field + 2-4 yrs experience in clinical trial registries, regulatory agency transparency or drug development with a ... trial disclosure associate ii. + north...well in a global, team environment skills: MS-WORD, CTMS ( Clinical Trial Management Systems) Equal Opportunity Employer:… more
- AbbVie (CA)
- …(IEST) lead , Clinical Program Lead and Clinical Science Lead and Clinical Scientist. The Associate Director, Clinical Development should ... Development Plan at the Clinical Trial Team level. The position supports the Clinical Project Lead and Clinical Science Lead in the development… more
- University of Colorado (Aurora, CO)
- …mission of the University of Colorado, Anschutz Medical Campus, this role will lead clinical research initiatives and manage long- and short-term strategic ... planning in direct support of ongoing clinical trial advancements and operations. + Manage...activities. At the Director level, this role will strategically lead clinical research operations for the Gates… more
- Taiho Oncology (Princeton, NJ)
- …their best work for those who need it most. This is an exciting opportunity to lead clinical studies and experience multiple facets of Clinical Operations in ... Associate Director, Clinical Operations Pleasanton, CA,...budget, recruitment and country/site selection strategies, and provision of clinical trial materials. + Serves as main… more
