- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership ... and overall strategic oversight of study management and delivery for all therapeutic...with Asset and Portfolio Management (APM), GCO Clinical Trial Business Operations (CTBO), and GCO Study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategic documents, including NNI Evidence Generation Plans and Product Development Plans Clinical study management : Provide regional medical & scientific ... Position Use medical and clinical expertise in design, implementation and monitoring of clinical studies (from Phase 1 to 4) in a team setting. Provide… more
- Arthrex (Naples, FL)
- …final/report, and publication. The position will mainly focus on developing clinical study protocols and associated documents, facilitating protocol amendments, ... this job is to provide technical and medical writing support for clinical study projects.Essential Duties and Responsibilities: Perform comprehensive literature… more
- George Washington University (Washington, DC)
- … Management System (CTMS). Acts as a communication liaison between GW OCR, clinical study staff, and internal and external customers during the clinical ... to ensure alignment with the final language in the clinical trial agreements, reviews by risk management ,...across Phases II-IV and ICH GCP Good understanding of clinical research trial protocols, associated study specifications,… more
- Merck & Co. (Rahway, NJ)
- …and ensures continuity of site relationships through all phases of the trial.Performs clinical study site management /monitoring activities in compliance with ... as primary site contact and site manager throughout all phases of a clinical research study , taking overall responsibility of allocated sites. Actively develops… more
- Merck & Co. (North Wales, PA)
- …of our existing and pipeline products to produce safe, effective, innovative medicine.The Clinical Sciences & Study Management (CSSM) department is building ... the Clinical Trial Team (CTT)May work closely with the Medical Writer on clinical /scientific and regulatory documents and the Study Manager on study … more
- TalentBurst, Inc (New York, NY)
- …timely completion of all duties. Maintains appropriate documentation associated with the assigned clinical study . Ensures studies are conducted according to ... * Documents subject information as it pertains to the clinical study according to the principals of...study sponsor according to GCP. * Completes the clinical trials management system and electronic/paper case… more
- Novo Nordisk Inc. (San Antonio, TX)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …resolve or escalate to appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve or ... clin pharm patient studies , and Phases 1-3 clinical trials at the study and program...Clinical Operations on plans for successful implementation of studies . Responsible for management of compounds at… more
- Merck & Co. (North Wales, PA)
- …Lead Clinical Scientist and study team with the scientific conduct of clinical studies . In this position, you will have the opportunity to develop your ... team.Job ResponsibilitiesResponsible for specific clinical /scientific activities on a single study or across multiple studies (eg, medical monitoring, lab… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Daiichi Sankyo and regulatory requirements.Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management Plan, ... and Strategy:Establishes Data Management strategy at the project and/or study level for a smaller number of projects/ studies Proactively identifies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical activities as appropriate.Responsibilities Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... Ensure the global clinical operations systems for management of company sponsored studies review and...and approvals are current and accurate.Liaison and reporting on study activities with other relevant GOMA functions and the… 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 ... Management :Provides guidance for collection of all external data management deliverables for assigned DS Program / Studies...to support the collection of diverse external data types.Advises Study Data Manager on complex vendor management … more
- Eisai, Inc (NJ)
- …phase I-IV global clinical trials including functional services.Accountable for vendor management ; providing guidance to study teams on vendor selection and ... Suite with a good understanding of other IT systems for contract management and clinical development.#LI-TS1Eisai Salary Transparency Language:The base salary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and represents function to standards team as an extended part of committee. Advise Study Data Manager on complex vendor management issues and provides guidance ... and SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical company,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …provide safety leadership including but not limited to clinical studies , post-marketing surveillance, signal detection and management , important safety ... represent the CSPV on the Global Product Team or specific sub-teams such as clinical study team and submission team, providing the safety leadership and serving… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the Study ... International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and… more
- Insmed Incorporated (Bridgewater, NJ)
- … methodology, protocol design, project management and regulatory requirements for clinical studies .Must have a global perspective and mindset, with the ... by working closely with Clinical Scientists and Clinical Operations personnel on clinical studies...needed.Collaborate with team and CROs to prepare and finalize clinical study protocols, associated amendments and Special… more
- Tris Pharma (Monmouth Junction, NJ)
- …colleagues, the incumbent contributes to the design, data collection and reporting of clinical studies in a manner consistent with industry standards, applicable ... documents, Investigational New Drug (IND) annual reports, Investigator's Brochures, clinical study reports and scientific presentations including abstracts,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …term experiments to advance clinical development. ResponsibilitiesServe as QCP representative on Clinical studies or take a lead on Clinical pharmacology ... with external CROs, collaborate and represent QCP on internal teams including Clinical Development Operations, Global Project Management , Bioanalysis, and Drug… more
