- Novo Nordisk Inc. (WA)
- … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages relationships with… more
- 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 ... leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and updates… more
- Novo Nordisk Inc. (Irvine, CA)
- … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages relationships with… more
- Daiichi Sankyo, Inc. (Bernards, 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, ... Job Summary: The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good … more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Ophthalmology will focus on driving strategy, development, and ... directors responsible for clinical programs.Supervises development of clinical documents including development plans, protocols, trial related documents,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Research (CESR) projects. Candidates should have a comprehensive understanding of clinical trial management, with firsthand experience managing collaborative ... action items. Coordinate with stakeholders to ensure timely follow-up and resolution of issues. Clinical Trial Management: Oversee clinical trial … more
- Merck & Co. (North Wales, PA)
- …in research activities for innovative statistical methods and applications in clinical trial development.Mentors and guides junior staff in functional ... eg SAS and/or R.-Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.-Strong oral and written communication… 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. (North Wales, PA)
- …Life Sciences, Engineering, or related field plus 9 years in a clinical trial environment (Analysis & Reporting,- Information Technology, Data Management ... Sciences, Engineering, or related field plus 6 years in a clinical trial environment (Analysis & Reporting,- Information Technology, Data Management etc.) in… more
- Merck & Co. (Rahway, NJ)
- …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Kenilworth, New Jersey research… more
- Merck & Co. (North Wales, PA)
- …or related field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life ... related field plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal… more
- Merck & Co. (Rahway, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… 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 ... 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
- Merck & Co. (North Wales, PA)
- …support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the ... the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US… more
- Merck & Co. (North Wales, PA)
- …location strategies. Contributes to the strategic vision and optimization of Global Clinical Trial Organization. Education Requirements: BA or BS degree, ... Job DescriptionThe Associate Vice President, Global Data Management & Standards...& Standards (GDMS) is responsible for ensuring that all clinical data management products and services are effectively delivered… 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
- Catalyst Clinical Research LLC (Raleigh, NC)
- …Project Manager. + Internal support is provided to the Field Monitor from the assigned Clinical Trial Associate . + Works closely with the extended study team ... As a Senior Clinical Research Associate , you will monitor clinical trial programs and manage regional clinical trial sites to support biological… more
- Catalent Pharma Solutions (Kansas City, MO)
- …Kansas City, MO is hiring a Clinical Development and Supply (CDS) **Returns Associate III** supports clinical trial projects through the processing of ... **Returns Associate III** **Position Summary:** Catalent is a global,...returned clinical trial medications that are returned by clinical … more
- Catalent Pharma Solutions (Kansas City, MO)
- … Associate II role. The Kansas City Development & Supply Distribution Associate II supports clinical trial projects through accurately picking ... **Distribution Associate II** **Position Summary** Catalent is a global,...Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range… more
- AbbVie (New York, NY)
- …a framework required by the FDA for all clinical studies (PhIII) to improve clinical trial diversity. With this role, you will be an important member of the ... our understanding of disease disparities and the effects on clinical trial populations. This role will report...trial populations. This role will report into the Associate Director, Diversity & Patient Inclusion. Responsobilties: + Drive… more
