- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… 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 ... Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities Study...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Merck & Co. (North Wales, PA)
- …with a minimum of five (5) years SAS programming experience in a clinical trial environment.Required Experience and Skills: Experience with study data standards ... external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management, Clinical and other project stakeholders.-Primary ResponsibilitiesSupporting … more
- Merck & Co. (Rahway, NJ)
- …processes for diverse biotherapeutics, and efficiently manufacture material to supply clinical trials . We are also responsible for commercial process ... Job Description Senior Scientist, Process Cell Sciences (PCS) at Rahway,...as a technical lead and functional area representative on project teams. Position Qualifications: Education Requirement: PhD in Molecular… more
- Merck & Co. (North Wales, PA)
- …to these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory ... and other of our company's Research Laboratories Scientists in designing and analyzing clinical trials , and in coordinating the statistical activities for … more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational or marketed Oncology drugsPlanning clinical trials (design, operational plans, settings) based on these ... development strategiesMonitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs.Analyzing and… more
- Merck & Co. (North Wales, PA)
- …of the study protocol.Prepares oral presentations and written reports to effectively communicate clinical trial results to the project . team, company ... responsible for statistical planning and data analysis of Phase I/II oncology clinical trials . This position requires strong communication skills, interpersonal… more
- Novo Nordisk Inc. (Irvine, CA)
- …the application of those principles to trial planning and conduct of clinical trials Demonstrates proficiency with computer skills (MS Office, MS Project ... Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex… more
- Merck & Co. (North Wales, PA)
- …with talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director ( Sr . Principal Scientist) has primary ... clinical development strategies for investigational or marketed Oncology drugs-Planning clinical trials (design, operational plans, settings) based on these … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in clinical trials required.Demonstrated ability to define clear clinical trial translational strategies anchored in disease biology and drug mechanism ... Global Project Team to drive scientific decision-making both from non- clinical and clinical translational aspects, through close collaboration with… more
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... position is a key collaborator with statistics and other project stakeholders in ensuring that project plans...at least 5 years SAS programming experience in a clinical trial environment orMS in Computer Science,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …models to aid in target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he will develop a QSP ... target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial designDevelop and rigorously assess the functionality,… more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational drugs and planning clinical trials (design, operational plans, settings) based on these ... development strategiesMonitoring and managing the conduct of ongoing or new clinical trials for investigational drugsAnalyzing and summarizing the clinical… more
- Merck & Co. (North Wales, PA)
- … clinical development strategies for investigational or marketed Oncology drugs;Planning clinical trials (design, operational plans, settings) based on these ... development strategies;Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs;Analyzing and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …investigators is expected. The CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... Clinical Science function. He/she will be responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each… more
- Merck & Co. (North Wales, PA)
- …meeting. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion ... developments, regulatory requirements, the competitive landscape, and commercial considerationsPlanning clinical trials (design, operational plans, settings) based… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actual product Responsible for all areas related to patient safety in clinical trials Act as member of the trial safety group for dose escalation decisions ... (phase I trials ) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure (IB),… more
- Merck & Co. (North Wales, PA)
- …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
- 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 ... manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves… more
- Merck & Co. (North Wales, PA)
- …statistical analysis and high-quality data to support decision making in clinical trials .Support statistical programming activities for Early Oncology ... development and safety evaluation.Collaborate with statistics and other project stakeholders in ensuring project plans are...with all of the following: SAS programming in a clinical trial environment including data steps, procedures,… more
