- Daiichi Sankyo, Inc. (Bernards, NJ)
- …report outputs, reviews clinical study and post-marketing protocols and the Clinical Study Oversight Plan, day-to-day management of DS Safety Notification ... Operations SPOC for study teams to ensure consistency and compliance across clinical study safety reporting and activities.Global Management Strategy and Goals… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the ... 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. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ability to prioritize workloadQuality orientation: attention to detail, accuracyAbility to exhibit project management skills Daiichi Sankyo, Inc. is an equal ... by a deep understanding of the current operating modelDrive key project deliverables, including requirements definition, process design, solution design, test… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management . The Tech ... 21 CFR Part 11, SDLC, GAMP, ICH preferred Licenses and Certifications- Certified Project Management Professional (PMP)-PMI preferred Travel Ability to travel up… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages ... those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position requires skills in working in a fast-paced environment, continuous improvement, project management , change management , and risk management ... in audits and inspections to provide study and/or program-level information as needed. Project Management : Responsible for on-time completion of medical coding… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in ... to drive data excellence and enhance the efficiency of our clinical research operations.Key Responsibilities:- Lead Data Management Initiatives:-Direct the… more
- Merck & Co. (Rahway, NJ)
- …its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional teams with sufficient influence ... of our company. - Position Description/Summary: - The GPAM Associate Director, Project Manager, is a core...and mastery of project management to take on challenging assignments… more
- Merck & Co. (Rahway, NJ)
- …disease area, the functions and processes relevant to drug development, and project management principles as applicable to the pharmaceutical industry.Primary ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical...Respiratory will focus on driving strategy, development, and life-cycle management activities in the Cardiovascular & Respiratory Therapeutic Area… more
- Merck & Co. (Rahway, NJ)
- …for clinical trial projects (data, analyses, tables, graphics, listings)Strong project management skills; leadership at a program level; determines approach ... Job DescriptionPosition Description: Associate Principal Statistical Programmer - Oncology (Hybrid) In BARDS (Biostatistics and Research Decision Sciences), a… more
- Merck & Co. (Rahway, NJ)
- …and present ideas to senior leadershipExcellent communication, presentation, negotiation, project management , and organizational skillsExperience with leading ... process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and… more
- Merck & Co. (Rahway, NJ)
- …opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions, ... will preferably have experience with high concentration biologics to support clinical and commercial development. Maintaining a strong network internally and across… more
- Merck & Co. (Rahway, NJ)
- …analytical, communication skills (written and oral) in addition to results-oriented project management skills Preferred Experience and Skills: At least ... and lead a team of TA dedicated global and regional directors and associate directors. The Executive Director, Value & Implementation (referred to as EDMA) engages… more
- Merck & Co. (Rahway, NJ)
- …stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure timebound progression of portfolio, initiatives for ... driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will report to… more
- Merck & Co. (Rahway, NJ)
- …of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Kenilworth, New Jersey research ... facility.- The Associate Principal Scientist is a laboratory-based scientific role tasked...of release, characterization, and stability assays for testing of clinical trial material and in support of product and… more
- New York University (New York, NY)
- The NYU School of Professional Studies seeks a Clinical Assistant/ Associate Professor of Project Management for the Division of Programs in Business, ... a vital aspect of the role. Reporting to the Associate Dean of the Division of Programs in Business,...closely with the Academic Director of Project Management Programs and department, the clinical faculty… more
- Merck (Rahway, NJ)
- …+ Project Management Skills: strong knowledge of the principles of project management and clinical customer relationship management . + Technical ... preferred. + At least 8 years of experience in project management . + At least 5 years...clinical supply planning function. + Proven record in project / portfolio management . + Knowledge of… more
- Merck (Rahway, NJ)
- **Job Description** **Job Overview:** We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management ... clinical research operations. **Key Responsibilities:** - **Lead Data Management Initiatives:** Direct the development and maintenance of comprehensive databases… more
- Merck (Rahway, NJ)
- …the R&D pipeline. The Associate Director is expected to provide project management leadership and drive cross-functional teams with sufficient influence and ... human health and business. Under GPAM, the CMC Integrated Project Management (CIPM) organization was formed to...Clinical strategies. ** ** **Position Description/Summary:** The CIPM Associate Director, Project Manager, is a core… more
