- Novo Nordisk Inc. (Plainsboro, NJ)
- … Director and Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations ... This role may also lead the Core Medical Team, Project Team (co-chair), and National Advisory Board meetings for...Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... activities pertaining to clinical trials, including but not limited to: data management...and timely execution and delivery of deliverables at the trial level. Primary activities include, but are not limited… more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, ... management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written communication skills.… 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
- Merck & Co. (Rahway, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Merck & Co. (Rahway, NJ)
- …in meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies.Ensures the statistical designs ... Involved in research activities for innovative statistical methods and applications in clinical trial development. Education and Minimum Requirement: PhD or… more
- Merck & Co. (North Wales, PA)
- …Job Responsibilities Responsible for the operational planning, feasibility, execution and conduct of clinical trial (s).Serves as the Clinical Trial Team ... (study team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.Liaises with partners, vendors, and vendor management… more
- Merck & Co. (Rahway, NJ)
- …contact with stakeholders including the Global Project Manager, Global Trial Manager, Clinical Sub Team, Clinical Trial Team and Outsourced Trial ... Laboratories drives breakthrough science through drug discovery, development and clinical evaluation that radically changes approaches to medical need.- Finance… more
- Merck & Co. (Rahway, NJ)
- …Lead research activities for innovative statistical methods and applications in clinical trial development. Collaborates in publication of research results ... project as neededLead biostatistics in early or late clinical development planning to ensure that study designs are...SAS and/or R.-Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to… more
- Merck & Co. (Rahway, NJ)
- …in research activities for innovative statistical methods and applications in clinical trial development.-Mentors and guides junior staff in functional ... oral and written reports to effectively communicate results of clinical trials to the project team, company...SAS and/or R.-Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to… more
- Merck & Co. (North Wales, PA)
- …or related field plus 12 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life ... therapeutic area (TA) projects to the direct benefit of project teams and the Biostatistics organization.The position is a...10 or more years SAS programming experience in a clinical trial environment. Department Required Skills and… 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 ... field plus 7 or more years SAS programming experience in a clinical trial environment.Required Experience and Skills:Excellent interpersonal skills and ability… more
- Merck & Co. (North Wales, PA)
- …or related field and at least 5 years SAS programming experience in a clinical trial environment orMS in Computer Science, Statistics, Applied Mathematics, Life ... position is a key collaborator with statistics and other project stakeholders in ensuring that project plans...at least 3 years SAS programming experience in a clinical trial environment. Required Skills: Effective interpersonal… more
- Merck & Co. (North Wales, PA)
- …or related field plus 5 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life ... or related field plus 3 years SAS programming experience in a clinical trial environment.Department Required Skills and Experience: Effective interpersonal… more
- Merck & Co. (North Wales, PA)
- …preparation of status update reports, study closeout activities).- May serve as the clinical trial team (CTT) lead. -Leads team for timeline management, risk ... Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries...site selection criteria with cross-functional team.-Works closely with Global Trial Optimization (GTO) to: develop patient recruitment and retention… more
- Merck & Co. (North Wales, PA)
- …of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.MS (preferred) in Computer Science, Statistics, Applied ... of 7 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.Required-Experience and Skills:Expertise in SAS for system… more
- Merck & Co. (Rahway, NJ)
- …or related field plus at least twelve (12) years SAS programming experience in a clinical trial environment or a Master's degree (or its US equivalent) in ... Job DescriptionResponsibilities:Responsible for both people and project management and is accountable to set strategy...least ten (10) years SAS programming experience in a clinical trial environment.Experience must also include at… more
- Merck & Co. (Rahway, NJ)
- …biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, ... Relationship ManagementPreferred Skills:Biological Sciences, Biomedical Engineering, Biopharmaceuticals, Chemical Engineering, Clinical Medicine, Clinical Trial Designs,… 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 ... ICH Q2 and USP .Experience in representing analytical functional area on project teams.-Experience with complex glycan analysis and link to mechanisms of… more
- Russell Tobin & Associates (San Diego, CA)
- …is supporting an exciting medical device organization that has an opening for a Remote Clinical Trial Lead / Study Lead Responsibilities Establish, track ... What are we looking for in our Clinical Trial Lead / Study Lead?...with internal teams Identify risks that may impact the project Develop/revise and/or provide input in the development of… more
