- Formation Bio (New York, NY)
- …multi-center clinical trials. In-depth knowledge of ICH-GCP, FDA regulations, and global clinical trial guidelines. Strong strategic thinking and ... or a related field. Minimum of 10 years of clinical project management/ clinical operations experience,...a sponsor company. Experience in the integrated in house clinical trial execution model. Experience working with… more
- Merck & Co. (Chicago, IL)
- …leaders to ensure they have a medical contact within the company.Upon request from Global Clinical Trial Operations (GCTO), support Company-Sponsored ... for a specific compound or trial .Recommend potential study sites to Global Clinical Trial Operations (GCTO)/ Clinical Research.Address requests… more
- Merck & Co. (TX)
- …to patient enrollment and retention efforts to achieve study milestones Upon request from Global Clinical Trial Operations (GCTO) Recommends study sites ... policies Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) Research Upon… more
- BeOne Medicines (Emeryville, CA)
- … Trial Diversity + Primary focus is to support BeOne's goals to increase global clinical trial diversity across BeOne's portfolio and pipeline assets. + ... **General Description:** Reporting to the Head/Director of Clinical Trial Diversity, the Associate Director will operationalize BeOne's clinical trial … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. We are currently seeking a Clinical Trial Business Operations Intern for Summer 2026. This ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...you will provide operational and analytical support to the Clinical Trial Business Operations (CTBO)… more
- Aequor (Basking Ridge, NJ)
- …or returned drug supply as well as experience managing third-party contract clinical supply operations required Global experience required (member ... knowledge of blinding approaches and technologies to support various clinical trial designs (randomized, double-blind, double-dummy, placebo-controlled,… more
- Insmed Incorporated (San Diego, CA)
- … Clinical Development, you will support and work predominately with the Clinical Trial /Indication Lead(s) and Medical Monitor(s) for assigned protocols and/or ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...will provide clinical and scientific support to clinical development and operations , regulatory, medical affairs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a minimum of 7 years relevant experience required- Experience Qualifications- Experience in global clinical operations methods and processes in industry ... study team in end-to end delivery of the clinical trial with consistency, quality and per...or outsourced studies with elements of insourcing. This includes global operational execution and delivery of clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and compliance. Knowledge about writing processes and procedures. Basic understanding of clinical trial development and operations Daiichi Sankyo, Inc. ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- …discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations )Provide clinical ... mutual respect, encouragement, and teamwork. As part of the global team, you will collaborate with talented and dedicated...Immunology, Clinical Judgment, Clinical Medicine, Clinical Research Management, Clinical Trial … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices ... on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams...evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required… more
- Eisai, Inc (San Diego, CA)
- …study teams and leadership, ensuring visibility into key milestones and initiatives.Assist global clinical operations during health authority inspections ... and radiomics) to ensure imaging strategies are optimized for clinical trial design and aligned with scientific...and issue resolution in collaboration with imaging core labs, clinical operations , and data management, and contribute… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensure high data quality, proactively identifying and resolving issues throughout the clinical trial process. Customer Focus / Stakeholder:Engagement Lead the ... or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in the areas of Medical… more
- Insmed Incorporated (NJ)
- …GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase ... change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations , and Program Management to drive proactive… more
- Insmed Incorporated (NJ)
- … clinical projects. Collaborates with cross-functional team members within Biometrics, Clinical Operations , Regulatory, and Clinical Development, as well ... statistical software packages Significant knowledge of the drug development process, clinical trial methodology, and relevant regulatory requirements for drug… more
- Insmed Incorporated (Minneapolis, MN)
- …insights to Insmed.Support research and development programs as requested by R&D, Clinical Operations , and Medical Affairs Departments. This may include ... strong related experience.Other Pharmaceutical experience - Medical Information, Medical Strategy, Clinical management/ trial experience and 2 years clinical … more
- BeOne Medicines (Emeryville, CA)
- … Operations ** is responsible to enhance Global Clinical Operations ' productivity and reduce clinical trial inefficiencies, by detailing the ... all applicable regulatory expectations. + Implement the GCO technology roadmap to increase Global Clinical Operations ' productivity, reduce rising costs of … more
- Insmed Incorporated (NJ)
- …milestones in launch planning.Medical leadership input for cross functional partners including clinical , operations , HEOR, and commercial to ensure that there is ... patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare… more
- GRAIL (Menlo Park, CA)
- …visit grail.com . The Sr. Clinical Trial Manager serves as a clinical operations leader, responsible for guiding the day-day execution of clinical ... ability to be flexible and creative yet ensuring the clinical trial is executed within compliance of...to identify areas of improvement to drive efficiency within Clinical Operations . **Responsibilities:** + Serves as the… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The** **Position** The Clinical Trial Manager (CTM), Translational Medicine and Early Development (TMED) is responsible for assisting in ... defining, monitoring and reporting on all aspects of key trial performance indicators, including for example, country and site...site personnel and investigators. Competencies + Phase 1 study operations + ICH/GCP + Clinical research +… more
