- 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 ... lifecycle of the actual product Responsible for all areas related to patient safety in clinical trials Act as member of the trial safety group for dose… more
- Bristol Myers Squibb (Princeton, NJ)
- …Committees, Vendors, Contract Research Organizations, GCP Officer (China only) + Internal: Global Trial Manager (GTM), Clinical Trial Managers (CTMs) ... Research or related work experience. + Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or… more
- Edwards Lifesciences (Trenton, NJ)
- …the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA submission experience + The ... + Act as core team member/lead biostatistician of assigned clinical trial (s) in US and international/global ...trials with skill levels exceeding the requirements of the Associate Manager Required or + Master's Degree or equivalent… more
- J&J Family of Companies (Trenton, NJ)
- …of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation ... Sr Clinical Research Associate - 2406209639W **Description**...parameters of study hypothesis, as well as to monitor clinical trial /study safety, in keeping with protocols,… more
- Bristol Myers Squibb (Princeton, NJ)
- …Summary / Objective** + Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial ... team members + May support clinical development planning (collaboration with Clinical Development Lead/ Clinical Trial Physician for provision and… more
- Merck (North Wales, PA)
- **Job Description** The Associate Vice President (AVP)/Section Head, Global Clinical Development, Ophthalmology will focus on driving strategy, development, and ... for clinical programs. + Supervises development of clinical documents including development plans, protocols, trial ...of clinical documents including development plans, protocols, trial related documents, clinical study reports and… more
- WuXi AppTec (Plainsboro, NJ)
- **Overview** The Clinical Research Associate III Senior Oncology performs and coordinates aspects of field-based and office-based monitoring and data quality ... specified by project manager or supervisor, including but not limited to mentoring of Clinical Research Associate (CRA) I and II personnel. + Participates in… more
- IQVIA (Abington, PA)
- …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
- Bristol Myers Squibb (Princeton, NJ)
- …strong working knowledge of Pharmaceutical R&D business processes, particularly in Clinical Trial Operations, with demonstrated command of key concepts, ... enable Global Development Operations (GDO) function, specifically focusing on Veeva Clinical Vault (Veeva CTMS, Veeva eTMF). This role owns end-to-end responsibility… more
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us . Global Data Management (GDM) is responsible for clinical trial data acquisition, data standards governance, data ... trials across the BMS Research & Development portfolio. The Associate Director, External Data Acquisition is a leadership role...Acquisition is a leadership role with oversight of external clinical trial data acquisition and integration and… more
- Astrix Technology (Trenton, NJ)
- …space. + Working knowledge of Clinical & Regulatory systems such as Clinical Trial Management System (CTMS), electronic Trial Master Files (eTMF), ... for the sale and growth of Astrix Technology Group's Clinical and Regulatory Consulting services to a portfolio of...representative of those that must be met by an associate to successfully perform the essential functions of this… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …**How you will** **contribute:** + Oversee and direct the work of the Clinical trial disclosure programming team (within the Programming Center of Excellence) ... life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Programming in Cambridge, MA, where you will...Standard code, AI and ML applications). + Collaborate with Clinical Trial Transparency Teams to implement data… more
- Bristol Myers Squibb (Princeton, NJ)
- …Include : + Conduct risk assessments specific to medical affairs and clinical trial /research activities, utilizing a combination of data analytics, ... d raft simple, easy to understand policies specific to medical affairs and clinical trial /research activities that empower the business to execute activities in… more
- Bristol Myers Squibb (Princeton, NJ)
- …leads the development and execution of statistical aspects for one or more clinical trials, including contribution to study trial design, analysis planning, ... their personal lives. Read more: careers.bms.com/working-with-us . **Purpose** The Associate Director, Biostatistics is a core member of cross-functional development… more
- Merck (North Wales, PA)
- …+ Involved in research activities for innovative statistical methods and applications in clinical trial development. + Mentors and guides junior staff in ... eg SAS and/or R. + Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V. + Strong oral and written… more
- Bristol Myers Squibb (Princeton, NJ)
- …leads the development and execution of statistical aspects for one or more clinical trials, including contribution to study trial design, analysis planning, ... treatment we pioneer. Join us and make a difference. **Purpose** The Associate Director, Biostatistics is a core member of cross-functional development teams and… more
- Merck (North Wales, PA)
- …Engineering or related field plus 9 years SAS programming experience in a clinical trial environment. MS in Computer Science, Statistics, Applied Mathematics, ... plus 7 or more years SAS programming experience in a clinical trial environment. **Department Required Skills and Experience:** + Excellent interpersonal skills… more
- Virtua Health (Marlton, NJ)
- …which may include quality improvement data and tracking information submitted to clinical trial sponsors and regulatory agencies. Coordinates visits for ... Additional Locations: Job Information: Job Summary: Coordinates and participates in clinical research studies conducted by principal investigators. Acts as a liaison… more
- Virtua Health (Marlton, NJ)
- …as required by protocol to ensure the submission of accurate information to clinical trial sponsors and regulatory agencies.* Responsible for submitting all ... *This is not a remote position* Summary:Coordinates and participates in clinical research studies conducted by principal investigators. Acts as a liaison… more
- Bristol Myers Squibb (Princeton, NJ)
- …the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & ... current regulatory requirements and expectation for small molecule arketing applications, clinical trial applications for projects, and/or lifecycle changes to… more
