- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …long term experiments to advance clinical development. ResponsibilitiesServe as QCP representative on Clinical studies or take a lead on Clinical ... potential products and drug candidates. The Manager , Clinical Pharmacology will support or take the lead... Clinical Pharmacology will support or take the lead on generation of study designs, protocols,… more
- Merck & Co. (North Wales, PA)
- …position drives scientific planning, strategy and execution of Phase 1-4 clinical studies . Under the direction of the Program Lead , you will collaborate with ... with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the set up… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical activities as appropriate.Responsibilities Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... clinical operations systems for management of company sponsored studies review and approvals are current and accurate.Liaison and...key activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and… more
- Merck & Co. (Rahway, NJ)
- …primary site contact and site manager throughout all phases of a clinical research study , taking overall responsibility of allocated sites. Actively develops ... continuity of site relationships through all phases of the trial.Performs clinical study site management/monitoring activities in compliance with ICH-GCP,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with ... Operations on SDV plan. Performs literature review and creates reference list for study . Study Planning: Contributes to clinical trial planning including… more
- Eisai, Inc (Nutley, NJ)
- …to evaluate biomarkers across programs, as well as the study statistician for clinical studies . As the statistical lead for biomarker development, this ... managing CROs. The immediate need is to manage early clinical development studies primarily in support of...conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …establishing data collection, data standards and data cleaning needs for DS Programs / Studies .Serve as the subject matter expert for Study Data Managers during ... of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical...to support the collection of diverse external data types.Advises Study Data Manager on complex vendor management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium ... and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design,… more
- Merck & Co. (North Wales, PA)
- …relationships with both internal and external groups. The Associate Director Pub Manager is expected to: Lead cross-functional Publication Teams for a number ... least 2 years of experience in publication managementUnderstanding of the clinical development process andclinical study data for assigned… more
- Eisai, Inc (NJ)
- …this is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 ... Programs. As the Lead Medical Writer, the incumbent ensures timely completion, accuracy...incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... disabilities.SummaryThis position supports early phase oncology development and leads complex studies in study design, statistical analysis and interpretation of… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: We are looking for a manager to lead and manage the validation and testing activities for our platform products. This role will ... platform team, in line with industry best practices and standards. Lead and manage a team of validation and test...or a related field, systems analysis, or a related study . Experience/Skills: Proven experience in a software testing or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as ... of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and...standards team as an extended part of committee. Advise Study Data Manager on complex vendor management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... role will consist of these components including: Expand and lead our Data Stewardship Working Group (DSWG) across functional...cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify… more
- Catalent (Philadelphia, PA)
- …every patient, consumer, and Catalent employee. The Role Support activities of the Manager , Training Program and the Training Lead .Cross train with Quality ... located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, ... global functions including but not limited to Commercial, Marketing, Medical, Clinical Development, Public & Government Affairs.Responsibilities- Lead the… more
- FISI - FUJIFILM Irvine Scientific (Santa Ana, CA)
- …significant time pressures.Strong scientific and medical writing skills.Knowledge in writing clinical study reports, integrated summaries of safety and ... Overview We are hiring a Clinical Affairs Program Manager . The ...or industry.Ability to obtain cooperation from other groups and lead cross functional teams.Proficient in Microsoft Word, Excel, PowerPoint,… more
- FUJIFILM Holdings America Corporation (Atlanta, GA)
- …customers' clinical needs, assist with the development and implementation of clinical studies and educational solutions, and help to build a ... clinical customers as it relates to participating in clinical studies , the incumbent is responsible for...plan for each key opinion leader to include potential clinical study engagement, educational/speaking opportunities, hands on… more
- FUJIFILM Holdings America Corporation (Atlanta, GA)
- …heritage with cutting-edge AI innovations to inspire a new tier of clinical confidence. The In-Vitro Diagnostic portfolio provides the golden standard of molecular ... based immunoassay technology for liver surveillance, cutting edge clinical diagnostic chemicals for leading laboratories across the country and diagnostic chemicals… more
- Marion County (Salem, OR)
- …and in writing.Ability to perform independently in a fast paced, team based environment; lead and supervise other clinical supervisors and lead staff; ... Health and Human Services is looking for a positive, adaptable, and collaborative Clinical Supervisor to work in the Adult Behavioral Health team! This position will… more
