- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within...other vendor performance against project goals and milestones to monitor… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …skills preferred.Excellent time management skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO ... Degree preferably in Life Sciences required Experience Qualifications4 or More Years in clinical trial outsourcing, health sciences or related field ( clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …learned, as appropriate.- Metrics:-When needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:-monitor GCO processes and ... with minimum of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations. Experience in training, process improvement, and project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary The purpose of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, ... and Figures (TLFs) generated by vendor , ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain… 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 ... around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management, will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and suggest innovative approaches to improve compliances and processes.- Some knowledge of clinical trial methodologies. Travel Ability to travel up to 10% ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to… more
- Merck & Co. (Rahway, NJ)
- …range of stakeholders including the Global Project Manager , Alliance Manager , Global Trial Manager , Clinical Sub Team, Clinical Trial Team, ... Job DescriptionPosition Description: Senior Specialist, Oncology Clinical Development Finance Under the guidance of the Oncology Clinical Development Finance… more
- IQVIA (Newark, NJ)
- **Elevate Your Career as a Clinical Trial Vendor Manager !** **About the Role:** Step into a world where your expertise in clinical vendor ... management becomes the catalyst for advancing medical breakthroughs. As a ** Clinical Trial Vendor Manager ** , you'll play a key role in our clinical … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …etc. + Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + ... Ensures compliance with the clinical trial registry requirements + Identifies outsourcing...collaborations + Applies advanced negotiation and interpersonal skills to vendor management + Advanced technical proficiency in trial… more
- Pfizer (New York, NY)
- …data set release and consistency in asset/submission data. **KEY RESPONSIBILITIES** + Serve as Clinical Data Scientist and Trial Lead for one or more clinical ... discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and...+ Ensure the required study-specific CDS documents in the Trial Master File (TMF) are of high quality and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, ... The **Sr Manager , Clinical Drug Supply & Logistics**...orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely… more
- AbbVie (Florham Park, NJ)
- …of systems developed internally or by the external vendors for individual clinical trial use. + Managing the design, development, validation, implementation, ... bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within...other vendor performance against project goals and milestones to monitor… more
- Merck (Rahway, NJ)
- …range of stakeholders including the Global Project Manager , Alliance Manager , Global Trial Manager , Clinical Sub Team, Clinical Trial Team, ... **Job Description** **Position Description:** **Senior Specialist, Oncology Clinical Development Finance** Under the guidance of the Oncology Clinical … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Excellent time management skills preferred. + Experience with PH.1 - PH. IV clinical trial vendor contracts required. + Experience with CRO contracts ... preferably in Life Sciences required Experience Qualifications + 4 or More Years in clinical trial outsourcing, health sciences or related field ( clinical … more
- Bristol Myers Squibb (Madison, NJ)
- …and vendor management. **Key Competency Requirements** + Demonstrated clinical trial experience, healthcare/medical/laboratory, or equivalent. + Vendor ... samples, loading documents to Shared Drive folders, etc.). + Independently review clinical study protocols, providing comparisons of vendor statements of work… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. **Summary** The purpose of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, ... and Figures (TLFs) generated by vendor , ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain… more
- Bristol Myers Squibb (Madison, NJ)
- …Professional (CMPP), and ISMPP active member highly desired + Understanding of clinical trial design and execution, statistical methods and clinical ... related to specified asset(s) in WWMH. **Key Responsibilities** The Senior Manager of Medical Communications is accountable for the following: Medical Communications… more
- Medtronic (Morristown, NJ)
- …RESPONSIBILITIES:** The following responsibilities are to be performed as appropriate in clinical trial case support and/or case support following commercial ... EKG, blood pressure, wave forms, and ancillary procedural solutions + Knowledge of Clinical trial protocols and CoreValve and other Medtronic TAVR product IFUs… more
