- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role...and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and suggest innovative approaches to improve compliances and processes.Some knowledge of clinical trial methodologies. Travel:Ability to travel up to 10% Daiichi ... Position Title: Senior Biostatistician Join a Legacy of Innovation 125...Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- IQVIA (Bridgewater, NJ)
- The Associate Clinical Project Manager /Local Trial Manager is a member of the core project team responsible for project delivery of clinical studies ... the Project Lead for partnering in overall project management, Clinical Lead for site management, the Project Management Analyst...coordination, tracking and financial analysis, and the Site Activation Manager as an expert in start-up. This is an… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Manager Clinical Statistician Date: Oct 21, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 58355 ... people to make a difference with. **The opportunity** The Senior Manager Clinical Statistician is...effectiveness of global statistics. + Implements innovative and cutting-edge clinical trial design, methodology and analysis. **Your… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …diseases, researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete ... traceability. + Oversees CPOs to ensure compliance with GMP, GCP, applicable Clinical Trial Regulations and agreed Work Orders and Clinical Supply… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager , Hematology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity ... on clinical studies and programs. As a Senior Manager in Hematology Clinical ...clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists… more
- Vitalief (New Brunswick, NJ)
- …is carried out as outlined. + Develops and distributes monthly financial reports to senior leadership of clinical trial revenue activity including active ... is responsible for preparing, maintaining, and negotiating budgets related to clinical trial activities. + Performs prospective reimbursement analysis according… more
- Merck (Rahway, NJ)
- …as the GCS spokesperson at clinical development related meetings (ie, Clinical Trial Teams) and product development related meetings. The incumbent must ... are not limited to:** + Participates as a key stakeholder on the Clinical Trial Teams (CTT)and collaborates closely with other functional area representatives… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- 1 of 2 Positions: As a Senior Manager in Clinical Sciences, Oncology, you will assist in the development, evaluation, planning and execution of clinical ... on clinical studies and programs. **As a Senior Manager in Oncology Clinical ...regulatory requirements and ICH/GCP guidelines. Proven track record in clinical trial process improvements. Considerable organizational awareness,… 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 ... in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities… more
- AbbVie (Florham Park, NJ)
- …concepts. + In-depth knowledge of CDASH and SDTM Standards In-depth understanding of clinical trial processes + Demonstrated ability to influence others without ... bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The ** Senior Clinical Study Lead** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large ... study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study...maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial… more
- Medtronic (New York, NY)
- …stakeholders to determine appropriate clinical evaluation strategy; may provide input to clinical trial design + Identify potential evidence gaps or risks to ... compassionate world. **A Day in the Life** **Bring your clinical talents to** **a leader** **in medical technology and...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The role of Senior Manager , Diagnostics Program Management & Operational Delivery, is expected to manage and deliver a portfolio of diagnostic projects (CDx, ... development and delivery of the diagnostic strategies. **As a Senior Manager , a typical day may include... clinical protocols, informed consent documents and other clinical trial deliverables and work with other… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …operational planning activities. This includes regular updates on new information that could impact clinical trial execution as well as ad hoc requests to input ... understanding of the drug development and commercialization process, with a focus on clinical development and trial execution + Experienced in understanding and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- **SUMMARY:** We are seeking a Senior Manager of Global Patient Safety who will play a key scientific role in safety strategies for molecules in clinical ... and analysis to support appropriate safety interpretation and benefit-risk assessment. As a Senior Manager of Global Patient Safety a typical day might include… more
- Catalent Pharma Solutions (Somerset, NJ)
- **Position Summary:** Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Manager , Quality Management Systems for the Quality Assurance department. This ... as the Training Department at the Somerset site. The Senior Manager , Quality Management Systems must possess...FDA and EU CGMPs and DEA regulations pertaining to clinical trial and commercial activities is strong… more
- Sanofi Group (Bridgewater, NJ)
- … responsibilities eg: managing or contributing to key study documents and activities from clinical trial set-up to clinical study report in compliance with ... development plan, work on the development of the clinical trial protocol, clinical ...and written results of product research, in concert with senior clinical personnel, in preparation for HA… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and ... and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments + Ability to work… more
