- Daiichi Sankyo, Inc. (Bernards, NJ)
- …may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection process in collaboration with the study team and ... outsourcing procurement management.Lead the creation of the CRO scope of work in collaboration with Outsourcing Procurement Management.Lead trial feasibility and… more
- ConsultNet (Elmendorf, TX)
- Control Room Operator San Antonio, TX 12-month+ contract $50/HR ConsultNet is seeking a Control Room Operator to support a client onsite in San ... management system. Required Skills: * A minimum of 5 years' experience as a Control Room Operator . * Must be willing and able to work rotating shifts,… 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 ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile. CRO / Vendor Oversight: Review CRO /vendor proposal and budget.… 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 ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile. CRO / Vendor Oversight: Review CRO /vendor proposal and budget.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …experts and external KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes effective communication between ... CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL and prepares material for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implementation of sourcing strategies for a specific set of R&D categories ( CRO , Medical Writing, BDM, etc..). Builds strategic plans for specific categories under ... Years Deep experience in pharma procurement & category management required- CRO experience preferred- Strong knowledge of clinical trials preferred- Demonstrated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in which Medical Monitoring activities are conducted by the Contract Research Organization ( CRO ) Medical Monitor (MM):Provides oversight to the CRO MM for ... clinical data review activitiesMay support addressing eligibility and medical questions from sites/ IRBsMay provide medical guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Clinical Study Teams, Central & Specialty Laboratories, and CROsOversee CRO partner sample management activities per study level including sample tracking, ... sample shipment manifests,and tracking ad hoc shipments in trackers)Review the CRO partner Sample Management Plan, to document cross-functional agreements on the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in which Medical Monitoring activities are conducted by the Contract Research Organization ( CRO ) Medical Monitor (MM):- Provides oversight to the CRO MM for ... clinical data review activities- May support addressing eligibility and medical questions from sites/ IRBs- May provide medical guidance for coding of AEs, medical history, and medications when needed- Clinical Development Expertise Strategy- In collaboration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead ... deliverables from vendors as well as work by in-house statistical programmers.- CRO / Vendor Oversight: Manages higher-level negotiations and provides oversight of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO , Biomarker, CDx, Clinical Supplies, central labs); Must have strong problem-solving skills ... PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO contracts preferred.Demonstrated ability to leverage digital data and analytics… more
- Merck & Co. (Rahway, NJ)
- …with Academic Research Organization (ARO), Contract Research Organization ( CRO ) and external statistical consultants.The incumbent may initially work ... in a specific disease area.- Primary activities :Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product developmentLead a team of statistical and/or programing staff assigned to a… more
- Aequor (Thousand Oaks, CA)
- …experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting) Preferred Qualifications BA/BS/BSc in ... obtained working on clinical trials in a biotech, pharmaceutical or CRO company Clinical trial management experience Operational performance experience International… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or other supplemental studies to support development of Dx devices under design control process. They will lead identification and selection of Dx assays and ... actionsSupports development of Dx product portfolio under design and change control regulations (ISO 13485, ISO 20916, IVDD/IVDR, and QSR). Supports analytical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical section of regulatory documents; Oversees management and performance of CRO ; Participates in creation of developmental and regulatory strategy; Drafts ... protocol profiles and sections of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with stakeholders to ensure a compliant ready state of operation.Ensure that CRO / Vendor quality events/ incidences are adequately reviewed and CAPAs followed up ... and / or closed as appropriate. Serve as a key contributor on several leadership teams and governance committees to provide quality overview, metrics, trends, impacting the Business portfolio: a. Research Committee/ CDx/Translational Oncology/Precision… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical section of regulatory documents; Oversees management and performance of CRO ; Participates in creation of developmental and regulatory strategy; Drafts ... protocol profiles and sections of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …departments within the Company. Also communicates with outside consultants (ie CRO 's) as needed. Qualifications: Successful candidates will be able to meet ... the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)Bachelor's Degree preferably in a scientific discipline required.Advanced degree (eg, Masters, Pharm.D., Ph.D., MD, JD)… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …development process and pharmaceutical / biotechnology marketplace, of the preclinical CRO industry, and previous demonstrated experience with SalesForce or a ... similar Client Relationship Management tool.Must have superior professional-level written and verbal communication skills; a high degree of professionalism, excellent judgment, problem-solving and decision-making skills. Demonstrated ability in managing a wide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …goals of the external collaborations. Establish and maintain effective communication between CRO / vendors / ARO. With the Companion Diagnostics Lead, develop a ... companion diagnostic plan for the program across all relevant indications as needed. Leverage disease area strategy or cross-asset strategy by working together with Translational Strategy Leads on other projects, internal and external experts. Qualifications:… more
