- Merck & Co. (North Wales, PA)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... Senior Director will manage the entire cycle of clinical development, including study design, initiation, execution,-monitoring, analysis, regulatory reporting,… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The RoleThe Senior Manager, Clinical Programming is responsible for the establishment, governance, and ... expert on data standards, reporting and analysis standards, change control management and related tools/applications Creates quality control processes, metrics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management , Biostatistics, Pharmacology, and other ... internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned… more
- Aequor (Thousand Oaks, CA)
- Senior Specialist QA Remote any time zone OK...Does the thought of building an entirely new digital quality management system, excite you? Do you ... processes within a hard-working team? If you have a passion for streamlined, user-friendly Quality Management System enabled by digital and want to be part of… more
- Merck & Co. (Rahway, NJ)
- …to effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. ... our depot network and further through to distribution and management of materials to the clinical site....Trial Operations (GCTO) Regional colleagues and Global - Development Quality (GDQ) to address clinical supply related… more
- Merck & Co. (Rahway, NJ)
- …outsource partner programming staffActive in professional societiesVETJOBS#EBRGBARDS2020SPjobsRequired Skills: Clinical Site Management , Clinical Testing, ... Job Description Responsibilities :This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early… more
- Insmed Incorporated (NJ)
- …one compound to ensure all are delivered on time, within budget and with high quality . This role may manage clinical operations team members, as delegated by ... lead over an 1-2 indications within one compound, in collaboration with the Senior Director, Clinical Operations. Ensures consistent and successful execution of… more
- Merck & Co. (Rahway, NJ)
- …, Learning New Concepts, Manufacturing Compliance, Operational Excellence, Personal Initiative, Quality Auditing, Quality Management , Regulatory Compliance, ... Job Description Senior Specialist , External Capabilities Validation & Compliance...Operations & Compliance team and drive a culture of quality and operational excellence across the global AR&D network.… more
- Insmed Incorporated (NJ)
- …plans and documentation and provides regular study status updates to senior management .Manages vendors' adherence to contractual obligations including ... Clinical Trial Manager will be responsible for the management and oversight of phase I-IV clinical ...proactively recognizing changes in scope and collaborating with senior management to ensure timely completion of… more
- Merck & Co. (North Wales, PA)
- …partner programming staffActive in professional societies#BARDS2020SPjobsVETJOBSEBRGRequired Skills: Clinical Testing, Computer Science, Data Management , ... benefit of patients and global human health.This position provides high quality statistical programming deliverables for global stakeholders in Early Development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reports are properly trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead) is fully informed of the ... organization. This will include providing innovative strategies to continuously improve Global Clinical Operations quality and metrics. IT will also include… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years related professional experience required.Must have professional experience Project Management , Clinical Supply Management , and/or Clinical ... position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives,… more
- Merck & Co. (North Wales, PA)
- Job Description Responsibilities: Provide oversight and quality management of submission data standard deliverables for world-wide regulatory application ... convert complex ideas and information into simple readable form.Solid project management skills.Familiarity with clinical data management concepts.Strategic… more
- Merck & Co. (Rahway, NJ)
- …and coach to the HF team and key stakeholders across R&D, clinical , regulatory, marketing, manufacturing, and quality functions.Educate and build awareness ... Job DescriptionThe Senior Director of Human Factors (HF) will provide...HF domain (beyond combination products).Apply strategic planning, rigorous budget management , and sound scientific business decision-making to balance short-term… more
- Insmed Incorporated (NJ)
- …early clinical development through product launch and life cycle management .Ensure HEOR strategies and tactics are cross-functionally aligned and meet the ... other, and for the future of science, we're in. Are you?About the Role:The Senior Director, HEOR is a strategic leader responsible for the development and execution… more
- Formation Bio (New York, NY)
- …Methodical - Brings rigor to semantic modeling, ontology mapping, and data quality management . Collaborative Partner - Works seamlessly across pillars, enabling ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...to patients faster and more efficiently.About the PositionAs a Senior Data Engineer at Formation Bio, you will focus… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Formation Bio (New York, NY)
- …of global regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk ... you will have the opportunity to establish the strategic development and operational management of Formation Bio's quality assurance program to support the… more
- Insmed Incorporated (NJ)
- …consistent with NIST and FDA data protection standards.Partner with Legal, Compliance, Clinical Operations, Quality and R&D to proactively manage risk across ... seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role will manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oversight Plan etc.)-Ensure operational study-level timeline, budget, deliverables and quality management -Facilitate escalation and resolution of issues with ... study team in end-to end delivery of the clinical trial with consistency, quality and per...and decision-making, ability to delegate, strategic thinking, conflict resolution, clinical project management experience and attention to… more
