- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the CRO scope of work in collaboration with Outsourcing Procurement Management. Lead trial feasibility and site identification activities in collaboration with ... the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations… more
- Merck & Co. (Rahway, NJ)
- …The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively ... clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head...and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO). Contribute to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the CRO scope of work in collaboration with Outsourcing Procurement Management. Lead trial feasibility and site identification activities in collaboration with ... and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... global functions including but not limited to Commercial, Marketing, Medical, Clinical Development, Public & Government Affairs.Responsibilities- Lead the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …therapeutic modality selection, biomarker characterization and early clinical trial designInteract with, and possibly lead , cross-functional QSP MDT ... which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he/she will develop a… more
- Merck & Co. (Boston, MA)
- … pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for ... Job DescriptionThe Associate Vice President (AVP)/Therapeutic Area Head, Immunology Translational...and own Immunology strategy with other TA Heads (Discovery/Late-Stage Clinical Development). Lead key technical reviews for Immunology… more
- Merck & Co. (Rahway, NJ)
- … pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for ... Job DescriptionThe Associate Vice President (AVP) will be responsible for...strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the… more
- Merck & Co. (Rahway, NJ)
- …(popPK), PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into ... our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This...seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisionsFraming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros ... build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming subject matter… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …comprehensive Data Management expertise to promote best practices across the Clinical Trial lifecycle.Qualifications: Successful candidates will be able to ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
- Insmed Incorporated (Bridgewater, NJ)
- … Director of Biostatistics is responsible for the statistical aspects for complex clinical trial (s) or indication product line. This role leads the protocol ... will include, but not necessarily be limited to, the following: Lead complex clinical trials or indication corresponding to one or several compounds in… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking an ** Associate Director- Clinical Trial Management** to join our Oncology team as a part of our new Regeneron Cell Medicines (RCM) group. You ... will independently lead our clinical study, including planning, maintaining...identification of project risks and contingency planning. **As an Associate Director- Clinical Trial Management,… more
- J&J Family of Companies (Columbus, OH)
- Associate Director, Clinical Trial Learning & Training - 2406187889W **Description** Johnson & Johnson is recruiting for an ** Associate Director, ... competencies to define necessary training strategy. + Collaborate with the Head of Clinical Trial Learning & Training to improve the organizational strategy for… more
- Lilly (Indianapolis, IN)
- …Assurance (QA) is responsible for providing quality oversight of all materials used in clinical trials. PRD QA Clinical Trial (CT) Packaging is responsible ... for global packaging operations and provide on-going Quality oversight to outsourced Clinical Trial Packaging activities. The Packaging CP Oversight role is… more
- Ascension Health (Carmel, IN)
- …qualifications. Connect with your Talent Advisor for additional specifics._ **Responsibilities** Lead clinical research projects via study protocols and provide ... Ascension St. Vincent is looking for an **RN** - ** Clinical Trial Research Coordinator.** Minimum requirements: The...and Values encompass everything we do at Ascension. Every associate is empowered to give back, volunteer and make… more
- Amgen (Washington, DC)
- … project management experience or + Bachelor's degree and 5 years of clinical trial project management experience or + Associate 's degree and 10 years of ... you will be the primary point of contact to lead , manage and co-ordinate the conduct of clinical...external partners to ensure timely delivery, budget implementation of clinical trial results within the local country.… more
- University of Southern California (Los Angeles, CA)
- …the design and development of investigator-initiated trials (IIT) and their required clinical trial databases. The investigator-initiated clinical trial ... documents for clarity and consistency, and management of the clinical trial database design and implementation. The...the study. + Work with the study principal investigator, lead statistician, and Clinical Investigation Support Office… more
- J&J Family of Companies (Jacksonville, FL)
- Sr. Lead Clinical Research Associate ...Study Managers, Lead CRAs, CRAs and other clinical trial team members. * Maintain audit/inspection ... Johnson's Family of Companies, is recruiting for a **Senior Lead Clinical Research Associate ** located...Assist in the development, testing and training for key clinical trial information systems (eg, electronic data… more
- University of Colorado (Aurora, CO)
- …mission of the University of Colorado, Anschutz Medical Campus, this role will lead clinical research initiatives and manage long- and short-term strategic ... planning in direct support of ongoing clinical trial advancements and operations. + Manage...activities. At the Director level, this role will strategically lead clinical research operations for the Gates… more
