- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… more
- Daiichi Sankyo, Inc. (Bernards, 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 Clinical Operations, in adherence to the protocol, Good … 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
- Merck & Co. (Rahway, NJ)
- …to: Collaborate closely with biomarker scientists and project teams to plan clinical trial biomarker set-up using logistical strategies to ensure efficient ... Experience and Skills: Drug discovery experience, including familiarity with clinical trial execution in Oncology studiesBiomarker assay experience… more
- Merck & Co. (Rahway, NJ)
- …optimal trial design and monitoring of studies, producing high-quality clinical documents and presentations. The position requires a solid understanding of the ... Job DescriptionThe Associate Vice President (AVP)/ Metabolism Section Head in...development of assets within the Metabolism Section of Global Clinical DevelopmentMay serve as a senior therapeutic… more
- Genmab (Plainsboro, NJ)
- …and/or leading a small team to complete various programming efforts within a clinical trial .You will be responsible for ensuring integrity, consistency, and ... and authentic is essential to fulfilling our purpose.The Role & Department As a Senior Programming Associate or Programming Manager, you will be in the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experience with Supplier Management, Research Administration, Grant Operations, Grant Management, clinical trial management, or a similar research operations ... a difference? The Position Reporting to the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate...GCP Principles and the application of those principles to trial design, planning & conduct of clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure ... within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and ...Responsible for all areas related to patient safety in clinical trials Act as member of the trial… more
- Amicus Therapeutics (Princeton, NJ)
- …2292 # of openings 1 Apply Now (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1338) Senior Associate Clinical ... day-to-day activities associated with clinical trial operations. The Senior Associate Clinical Trial Manager is responsible for assisting the… 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 to ... the Project Lead for partnering in overall project management, Clinical Lead for site management, the Project Management Analyst...activities to bring revenue forward in partnership with the senior project leader. + Identify changes in scope and… more
- IQVIA (Parsippany, NJ)
- …applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. ... with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. *… more
- Pfizer (New York, NY)
- …plans, including data preparation and validation activities, among others. As a Senior Associate , your knowledge and skills will contribute towards the ... development process and data operations required for the reporting of clinical trial data (eg data review, study reports, regulatory submissions, safety updates,… more
- Bristol Myers Squibb (Princeton, NJ)
- …projects + Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects + ... we pioneer. Join us and make a difference. The Senior Manager, Clinical Data Management (Data Management...BMS R&D pipeline. This role reports to the Director, Clinical Data Management or Associate Director, … more
- Teva Pharmaceuticals (Parsippany, NJ)
- …statistical support to clinical studies or programs with the guidance of senior level statisticians (ie, Associate Director or higher) which includes, but is ... Senior Manager Clinical Statistician Date: Oct...effectiveness of global statistics. + Implements innovative and cutting-edge clinical trial design, methodology and analysis. **Your… 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 ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...vendors / ARO + Additional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… 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...mathematics, mechanical concepts, science, or computing - OR- + Associate degree and a minimum 6 years of work… 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 Clinical Operations, in adherence to the protocol, Good … more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …substantive research contracts (eg, SRAs, CRAs, MTAs, DTAs, Multicenter agreements, Clinical Trial Agreements, Consortium Agreements, Site Subcontracts, License ... Please note, this link is only accessible for MSK employees. Job Description Senior Contracts Associate , Research Contracts Team MSK's Office of General Counsel… more
- Bristol Myers Squibb (Madison, NJ)
- …Supervisor: Clinical Science Program Lead + Subordinate Roles (if applicable): Associate to Senior Clinical Scientists **Qualifications** + 5+ years ... Science team in the planning and execution of clinical trial activities to support the ...supervises a team of senior and junior Clinical Scientists to execute trial level activities… more
