- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... plan by function and team; Interprets and react accordingly to new preclinical/ clinical data (eg; Go/No Go decisions, reprioritization, etc.); Operational Project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... plan by function and team; Interprets and react accordingly to new preclinical/ clinical data (eg; Go/No Go decisions, reprioritization, etc.); Operational Project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Contract Research Organization ( CRO ) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing ... in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Contract Research Organization ( CRO ) Medical Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan- Accountable for the… more
- Novo Nordisk Inc. (WA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... guidelines, and relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in accordance with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labs or analysis labs in collaboration with relevant stakeholders including Data Management, Clinical Operations and QCP/CDx/ Clinical BiomarkersSupport ... of the end-to-end lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but not limited to near… more
- Merck & Co. (Rahway, NJ)
- …related drug/vaccine projects in Late Development Statistics.Lead the interaction with Clinical , Regulatory, Statistical Programming, Data Management, and other ... and ascertains needs for potential program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders including members of Global Companion Diagnostics, Translational Sciences, Global Clinical Operations, Biostats and Data Management and Clinical ... studies to support development of Dx devices under design control process. They will lead identification and selection of...leads clinical trial sample testing activities and data capture to support CDx regulatory submission or associated… more
- Merck & Co. (North Wales, PA)
- …support for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and other ... and ascertains needs for potential program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc. ... all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position also guides contract research organization ( CRO ) programmers and statisticians in preparing analysis files and performing ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project needs. The position works closely with contract research organization ( CRO ) programmers and statisticians and collaborates with internal programmers in ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO contracts preferred.Demonstrated ability to leverage digital data and analytics ... Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO , Biomarker, CDx, Clinical Supplies, central labs); Must have strong problem-solving skills and is… more
- Aequor (Thousand Oaks, CA)
- … clinical research experience ( clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other ... related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …More Years Deep experience in pharma procurement & category management required- CRO experience preferred- Strong knowledge of clinical trials preferred- ... sourcing strategies for a specific set of R&D categories ( CRO , Medical Writing, BDM, etc..). Builds strategic plans for...procurement for Global RD - for their specific categories.- Data Analysis Based Decision-Making- Uses rigorous analyses of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …enumerate key translational hypothesis that will drive scientific decision-making both from non- clinical and clinical translational aspects. In doing so, he or ... In addition, he or she will interact with the Companion Diagnostics Lead, Non- Clinical Research, Medical Affairs and other stakeholders to support the program. Other… more
- Walgreens (Deerfield, IL)
- … clinical operations in pharmaceutical/biotech/ CRO + 4+ years in a Clinical Data Management leadership role + Experience in project management and ... external professional projects and organizations such as Society for Clinical Data Management (SCDM), Clinical .../ biotech industry and / or Contract Research Organization ( CRO ) + At least 4 years' experience in … more
- Pfizer (South San Francisco, CA)
- …**MINIMUM QUALIFICATIONS** + Demonstrated successful experience in all relevant clinical data management activities in a BioPharmaceutical or CRO setting + ... around the world. **POSITION SUMMARY** As part of the Clinical Data Sciences (CDS) group, an integral...protocol review + Strong Project and Risk Management + CRO and vendor oversight experience preferred + Minimum 5… more
- AbbVie (Florham Park, NJ)
- …EDC, and IRT vendor contracts for assigned clinical trials + Supervise all Data Sciences staff (including equivalent CRO staff) for assigned clinical ... on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description AbbVie Clinical Data Strategy & Operations is the best-in-class team within its… more
