- Merck & Co. (Rahway, NJ)
- … clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents. Partners with Study Manager on study ... team members including clinical directors and study managers to lead/support clinical trial scientific activities in the Atherosclerosis & Metabolism TA.Job… more
- Merck & Co. (Rahway, NJ)
- …clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... and prioritization skillsAdvanced analytical skills with the ability to interpret clinical trial data andsynthesize conclusionsInteract with key stakeholders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immunology, or complex disease therapeutic area experience required- Working knowledge of Clinical trial data systems such as Medidata Rave (EDC), Metadata ... areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Data Standards is responsible for the development and sustainability of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensures quality delivery of all 3rd party data from diverse external providers for clinical trials , companion diagnostics trials , clinical development, ... and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology, with a deep understanding of the drug discovery and development process, clinical trials , and regulatory requirements. TravelAbility to travel up to 5% ... areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and suggest innovative approaches to improve compliances and processes.Some knowledge of clinical trial methodologies. Travel:Ability to travel up to 10% Daiichi ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and ultimately our ability to deliver live changing therapeutics to those in need. ** Clinical Trials Manager , Clinical Operations - Oncology (CTM)** ... is responsible for the execution of all Phase 1-4 clinical trials , across all therapeutic areas, around...Research, Medical Affairs and Development functions, ensures that all clinical trial activities are performed in accordance… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a ... key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely… more
- Mount Sinai Health System (New York, NY)
- …collaboration with the MM Medical Director, the Associate Director, and the clinical trials investigators; this candidate is responsible for the implementation ... and conduct of clinical trials with investigational anti-cancer agents at...of Good Clinical Practice, Human Subject Protection, clinical trial design, regulatory processes, and … more
- Mount Sinai Health System (New York, NY)
- …the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials . + Obtains informed consent under supervision of the ... Principal Investigator, Clinical Research Manager , or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects, and for studies… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager Clinical Scientist Hematology leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and ... interpretation of study data of a clinical development program. The Sr. Manager leads...clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists… more
- Pfizer (New York, NY)
- … Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all Data Monitoring and Management (DMM) activities ... you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials , you will apply cutting edge design and process development… more
- Hackensack Meridian Health (Hackensack, NJ)
- …transform healthcare and serve as a leader of positive change. The **Project Manager , Clinical Trials ** develops and implements comprehensive workflows and ... trial feasibility, start-up, conduct and close-out of all Clinical Trials being conducted within their assigned...**Responsibilities** A day in the life of a **Project Manager , Clinical Trials ** at Hackensack… more
- Mount Sinai Health System (New York, NY)
- **Job Description** As the Clinical Trials Manager , you will coordinate and manage multiple clinical trial projects and protocols, including ... field; Masters preferred + 6+ years of experience managing clinical trials , including 2 years in a...management and leadership skills **Responsibilities** + Manages and coordinates clinical trial and related research studies conducted… more
- Actalent (New York, NY)
- … clinical study team in accordance with standards. + Act as the project manager of the clinical study team to liaise and coordinate with internal stakeholders ... Job Title: Clinical Study ManagerJob Description The incumbent will be...trial management experience. + Experience with Phase II/III trials . + BS degree in life sciences or a… more
- System One (Florham Park, NJ)
- …a plus. + A minimum of 3 years' experience, including outsourcing for clinical trials , vendor negotiations, operations management, accounting, and finance. + ... Manager , Clinical Business Operations Job Category:...with a Clinical Development department and Global clinical trial experience. + Excellent written and… more
- Mount Sinai Health System (New York, NY)
- …management, and coordination of care for subjects enrolled onto IRB approved research studies/ clinical trials , as specified by the research protocol, across the ... group of patients/family/community members who have agreed to participate in research studies/ clinical trials .Provides care to patients with acute and complex… more
- Actalent (Basking Ridge, NJ)
- …will support knowledge management and departmental training efforts. Hard Skills + Global Clinical Trial Management + Hematology + START UP EXPERIENCE + Vendor ... Job Title: Clinical Study Manager Job Description As a Clinical Study Manager , you will play a pivotal role in the planning and execution of clinical … more
