- 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
- 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 ... difference? The Position We are looking to hire a Clinical Project Manager (CPM). This is a...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 ... 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)
- …deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development ... centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end...disease therapeutic area is a must. Working knowledge of Clinical trial data systems and/or EDC and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …opportunities and potential mitigations and develops new forecasts as required Ensures that clinical trial budgets remain on track and aligned with global ... Continuously monitors and reports on status and expected outcomes Ensures all clinical trial -related SAP transactions are posted appropriately Oversees payments… 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)
- …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)
- …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
- Genmab (Plainsboro, NJ)
- …to ensure efficient and effective trial operations.Point of Contact for Global Clinical Trial Managers: Act as the primary point of contact, facilitate ... communication and resolve issues.Vendor Owner:First Point of Contact for clinical trial vendors: Serves as the first point of contact for the vendors, across… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Gilead and help create possible, together. **Job Description** **POSITION OVERVIEW:** Clinical 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… more
- Amicus Therapeutics (Princeton, NJ)
- Senior Associate, Clinical Trial Manager (Contractor) Location Princeton, NJ Requisition ID 2292 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1338) Senior Associate Clinical Trial Manager (Contractor) Amicus… more
- Novo Nordisk (Plainsboro, NJ)
- …experience in the pharmaceutical industry + Minimum 2 years of experience as a Clinical Trial /Project Manager + Experience with global clinical ... difference? The Position We are looking to hire a Clinical Project Manager (CPM). This is a...with periodic audit of the TMF + Drive critical clinical trial activities including trial … more
- Actalent (Basking Ridge, NJ)
- … 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...audit activities. + Provide oversight of the transmittal of trial and site-level documents to the Document Control Center… more
- IQVIA (Bridgewater, NJ)
- The Associate Clinical Project Manager /Local Trial Manager is a member of the core project team responsible for project delivery of clinical studies ... the Project Lead for partnering in overall project management, Clinical Lead for site management, the Project Management Analyst...coordination, tracking and financial analysis, and the Site Activation Manager as an expert in start-up. This is an… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …etc. + Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + ... Ensures compliance with the clinical trial registry requirements + Identifies outsourcing needs of the study and leads and oversees engagement, contracting and… more
