- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary This position supports the strategy for driving global Clinical Study Start -Up activities for PV Safety Operations. This ... clinical study safety reporting and activities.Global Clinical Study Start -Up Documentation: Reviews... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the oversight 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 ... cross-functional internal and external stakeholders including but not limited to QCP, Clinical Biomarker, Companion Diagnostics, Clinical Study Teams,… more
- Sun Pharmaceutical Industries, Inc. (Jamesburg, NJ)
- …primary point of contact from clinical operations for assigned trials. Oversee study start up activities of CROs (eg Site identification, Feasibility, Site ... selection, Contract negotiation and Clinical Study Agreement finalization, Translations, EC and...timelines. Prepare and implement Quality control plan in assigned studies and ensure that clinical studies… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and immune disorders. **Summary** This position supports the strategy for driving global Clinical Study Start -Up activities for PV Safety Operations. This ... study safety reporting and activities. + Global Clinical Study Start -Up Documentation: Reviews... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains… more
- System One (Basking Ridge, NJ)
- …from Basking Ridge, NJ. JOB DECRIPTION: Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...attention. Skills: Demonstrates knowledge of complex processes related to clinical studies , regulatory issues, CRO operations, and… more
- Astellas Pharma (New York, NY)
- … Clinical Practice (GCP), and applicable regulations and guidelines from study start -up through to site closure. The Clinical Site Manager will manage ... Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start -Up Specialist (SSS) to ensure overall site management… more
- Hackensack Meridian Health (Hackensack, NJ)
- … Clinical Research Nurses, Clinical Research Coordinators, Regulatory and Study Start -Up Specialists, Clinical Data Coordinators, Study ... including regulatory, finance, and contracts to ensure efficient, competitive, and timely study start -ups and initiations. + Continually reviews study … more
- HSS (New York, NY)
- …Previously worked with industry sponsored/funded studies (specifically independent execution of study start up to close out) + Previous management experience ... can be part of our transformation across the enterprise. Clinical Research Manager - Industry Full-Time Summary:...will be responsible for submitting all visits required for study milestones (eg start -up/initiation, quality & audit… more
- Northwell Health (Glen Oaks, NY)
- …relevant federal and state regulatory and institutional policies. 4.Provides consultation during study start -up activities regarding development of study ... the purview of the FDA. 10.Prepares and forwarding monitoring reports to program manager . Working with study staff to address any concerns. 11.Promotes overall… more
- Terumo Medical Corporation (Somerset, NJ)
- Sr. Manager , Clinical Advisors Date: Sep 25,...reports. Clinical operational activities: + Support trial study start -up phases (support in writing ... wherever we go next!** **_Advancing healthcare with heart_** **Job Summary** Senior Manager , Clinical Advisor is responsible for developing and implementing the… more
- Mount Sinai Health System (New York, NY)
- …per specifications of the protocol; and monitors test results, as appropriate Documents clinical study and therapy in patient's chart and all other databases ... **Job Description** The Clinical Program Manager provides clinical...for the Nursing Staff regarding specific protocols. + Manage clinical trials portfolio and assure timely regulatory start… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …DS Programs / Studies . - Serve as the subject matter expert for Study Data Managers during the planning/ start -up, conduct and close-out of external data ... 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)
- …the oversight 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 ... cross-functional internal and external stakeholders including but not limited to QCP, Clinical Biomarker, Companion Diagnostics, Clinical Study Teams,… more
- Actalent (Edison, NJ)
- …of experience as a clinical research coordinator + Experience with Oncore Study - start up task list + Proficiency in using computerized systems like Sunrise ... trial protocols. This includes the preparation and review of study tools, verification of approvals, and collaboration with the...Disease/ Clinical Manager , IDX, TDS, and Medical Records… more
- IQVIA (Parsippany, NJ)
- **Job Overview** Join our team as a Clinical Research Site Manager , where you'll play a crucial role in ensuring our study sites operate seamlessly and ... selection, initiation, monitoring, and close-out visits in line with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. +… more
- Vitalief (New Brunswick, NJ)
- …with sponsors, interfacing with various internal departments as needed. + Facilitates clinical trial billing administrative start -up, insuring clinical ... are expanding our footprint rapidly as a value-add, innovative Healthcare, Research and Clinical Trials Consulting Company. As a result, we are seeking talented and… more
- The Cigna Group (Morris Plains, NJ)
- Job Description **JOB DESCRIPTION** The Clinical Account Executive (CAE) position is an exciting opportunity for a pharmacist who is looking to leverage their ... the Health Plan client's strategic goals and drive improved clinical and financial outcomes for their membership. In this...Acts in concert with assigned Account Executive and Account Manager to service the health management consultative needs of… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …Development Program and Study Team Involvement:** + Serve as an active member of clinical study teams to ensure Dx/CDx planning is in line with clinical ... The role of Senior Manager , Diagnostics Program Management & Operational Delivery, is...the Dx/CDx strategy in parallel to the corresponding Regeneron clinical drug development programs and studies with… more
- System One (Basking Ridge, NJ)
- …stakeholders to maintain ongoing ADA sample results tracking, which is needed for clinical study subject follow up visits decision making. Requirements: + ... Title: Manager II- Scientific Operations Location: Basking Ridge, NJ-...collaborating partners + Provides Scientific Operational Support for the Clinical Bioanalysis and Translational Biomarker teams including study… more
- IQVIA (New York, NY)
- …and takes proactive approach to gain efficiencies in work across protocols. + Study Start up: Assist with protocol development, sample size calculation, protocol ... + Leadership: Perform statistical team lead role on single studies . Through this, works closely with the Project Team...May be expected to present at bid defenses. + Clinical Study Report (CSR): Reviews or drafts… more