- 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
- Merck & Co. (Rahway, NJ)
- …with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the set up ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies . Under the direction of the...and design during study start up (eg, database set up)Lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...abroad, governmental, academic, community and industry organizations. The Senior Clinical Study Manager role is… more
- VNS Health (Manhattan, NY)
- VNS Health is seeking a Social Work Licensed Clinical Social Worker for a job in Manhattan, New York.Job Description & RequirementsSpecialty: Licensed Clinical ... organization's strategic vision and effectively meet our members' needs.Leads the BH clinical operations team with a strategic and growth-oriented mindset, aiming to… 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
- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...abroad, governmental, academic, community and industry organizations. The Senior Clinical Study Manager role is… 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
- System One (Tarrytown, NY)
- …management tasks for assigned study . * Coordinates, leads and performs clinical data management activities for assigned studies in accordance with client's ... Job Title: Clinical Data Manager Location: Fully Remote...o Monitors data clean-up process performed by CROs from study start -up through data archiving. o Provides… 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
- Terumo Medical Corporation (Somerset, NJ)
- Sr. Manager , Clinical Advisors Date: Aug 27,...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
- The 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
- Merck (Rahway, NJ)
- …with the Medical Writer on clinical /scientific and regulatory documents. + Partners with Study Manager on study deliverables. + Participates in the set ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies . Under the direction of the...up and design during study start up (eg, database set up)… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support ... serves as an expert resource to anticipate and resolve study /asset clinical and conduct issues. For assigned...forecasts and allocates resources (FTEs and budget) for the clinical program with support from Development Program Manager… 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
- Pfizer (New York, NY)
- …clinical experts as required. Maintain a thorough knowledge of assigned protocols. Conduct study start up activities at the site level including but not ... Activities that are required to assure end to end Clinical Trial Implementation ( start up to close...strategy in collaboration with the Study Operations Manager /Global Study Manager . Provide regional… more
- Bristol Myers Squibb (Madison, NJ)
- …instruments for clinical trials, facilitating the end-to-end process, and working with clinical study teams and vendors to meet study requirements. + ... delivery. + Review and coordinate study -level eCOA process documents with clinical study team members. + Oversee eCOA development and testing activities,… 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
- ICON Clinical Research (Farmingdale, NY)
- …all matters regarding our central laboratory services, following up and responding to clinical study specific inquiries from Sponsors, Physicians, CRA and CRO ... systems for new and/or amended protocols. Prepare and review clinical study specific materials. When possible, coordinate...Ensure that proper guidelines for communication are set at study start -up and maintained throughout a … more