- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …profile throughout product lifecycle Independently leads activities without supervision for assigned clinical studies Lead activities under the direction of ... clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety... studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical… 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
- 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
- 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
- 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
- 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 ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… 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
- 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
- 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
- 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
- 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
- Eisai, Inc (Nutley, NJ)
- …training, advanced product training, improved selling skills, disease state knowledge, clinical and business acumen application of the Eisai Selling model and ... developing team members to perform effectively in their roles.He/she serves as the lead point-person and training subject matter expert with the commercial brand and… more
- IQVIA (Bridgewater, NJ)
- …teams to improve patients' lives by bringing new drugs to the market faster. The Senior Clinical Lead is a member of the core project team responsible for ... clinical delivery of full service, large, multi-regional ...out of scope work. * Work as the primary Clinical Lead alongside other Clinical ...work. * Work as the primary Clinical Lead alongside other Clinical Leads to deliver… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …experiments to advance clinical development. **Responsibilities** + Serve 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
- Pfizer (New York, NY)
- …etc.), and lead translation of pre- clinical observations into clinical experiments and studies designed to demonstrate proof of pharmacology, proof ... **ROLE SUMMARY** The Clinical Lead (CL), Internal Medicine RU...of clinical research plans into efficiently delivered studies . Creative in the conception of novel study… more
- Bausch Health (Bridgewater, NJ)
- …execute the clinical supply chain for current and new clinical studies and programs. **Responsibilities** Additional representative responsibilities will ... and design strategy for patient kits to support the clinical study design. + Support the IWRS...and closeout requirements + Evaluates vendor selection to support clinical studies according to capability and fit… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Clinical Development Lead sits within Clinical Development, ... and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Key...studies , with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication +… more
