- 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)
- …support training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested ... proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with a masters degree required- 3+ Years… 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 ... team members including clinical directors and study managers to lead/support clinical trial scientific activities in the Atherosclerosis & Metabolism TA.Job… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … development experience in the pharmaceutical industry Minimum 2 years of experience as a Clinical Trial /Project Manager Experience with global clinical ... You will be responsible for the successful execution of clinical trials from protocol finalization through closeout....assist with periodic audit of the TMF Drive critical clinical trial activities including trial … 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations (NACO) Manages and communicates financial status of ongoing clinical trials , including identification of variance and risks. Identifies ... mitigations and develops new forecasts as required Ensures that clinical trial budgets remain on track and...technical, regulatory, and legal terminology of contracts, preferably in clinical trials Must work with minimal direction.… 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
- Merck & Co. (Rahway, NJ)
- …DescriptionThis position contributes to the operational planning and execution of one or more clinical trials . In this position, you will have the opportunity to ... management, communication, and collaboration skills in support of our clinical trials .Job ResponsibilitiesMay have specific operational responsibilities for… 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 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
- 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
- Merck & Co. (Rahway, NJ)
- …and posters/oral presentations that report results from our company's General Medicine clinical trial program, as well as select early-stage development projects ... Skills Strong writing skills and competence in biomedical research General Medicine clinical trial publications experience Understanding of clinical research… more
- Genmab (Plainsboro, NJ)
- …for coordinating sourcing for new trials to ensure efficient and effective trial operations.Point of Contact for Global Clinical Trial Managers: Act ... as well as coordinate and manage outsourcing of new trials . The role will include responsibilities in - and...communication and resolve issues.Vendor Owner:First Point of Contact for clinical trial vendors: Serves as the first… more
- Genmab (Plainsboro, NJ)
- …synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners ... purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both… more
- Genmab (Plainsboro, NJ)
- …and/or leading a small team to complete various programming efforts within a clinical trial .You will be responsible for ensuring integrity, consistency, and ... purpose.The Role & Department As a Senior Programming Associate or Programming Manager , you will be in the Statistical Programming team and Development Operations… 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
