- Intra-Cellular Therapies, Inc (New York, NY)
- …results-driven individual to join our company, in the Clinical Operations Department as a ** Clinical Trial Manager /** **Senior Clinical Trial ... vendors, and patient advocacy organizations (as necessary) + Leads vendor selection activities (RFP, proposals, meetings, selection, and all...Clinical Operations is required; 2+ years as a Clinical Trial Manager + CNS… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …a Bachelor's Degree and minimum of 8 years of experience and success in a clinical trial /life sciences management role. Experience working with clinical drug ... The Senior Manager Development Operations & Portfolio Management (DO&PM) Vendor & Relationship Management (VRM) position is responsible to ensure that… 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...collaborations + Applies advanced negotiation and interpersonal skills to vendor management + Advanced technical proficiency in trial… 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...to build productive study teams and collaborations + Demonstrated vendor management experience + Technical proficiency in trial… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …who have vendor management experience, as well as experience in clinical trial operations including developing key study documents. We also require ... based in Armonk, NY or Basking Ridge, NJ._ A Clinical Study Associate Manager (CSAM) role supports...Study Lead (CSL) by taking responsibility for areas of clinical trial delivery. This role applies to… more
- Actalent (Basking Ridge, NJ)
- …supports the Clinical Study Lead by taking responsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies ... IMMEDIATE CLINICAL TRIALS ASSOCIATE MANAGER OPPORTUNITY WITH...Trial Management experience (Pharma/CRO) + 1-2+ years of Vendor /CRO Management experience + eTMF Experience (Experience maintaining the… more
- Pfizer (New York, NY)
- …, Study Start Up Project Manager , Site Intelligence Lead, Country Trial Manager , Site Care Partners, Site Excellence Partners, Site Relationship Partners, ... activities as applicable + Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator...Local Study Team (core members: (Lead) Site Care Partners Clinical Trial Assistant, ad hoc members: ICL,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, ... The **Sr Manager , Clinical Drug Supply & Logistics**...orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely… more
- Merck (Rahway, NJ)
- …The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively ... and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable...and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO). + Contribute to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development ... of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical...of diverse external data types. + Advises Study Data Manager on complex vendor management issues and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Excellent time management skills preferred. + Experience with PH.1 - PH. IV clinical trial vendor contracts required. + Experience with CRO contracts ... preferably in Life Sciences required Experience Qualifications + 4 or More Years in clinical trial outsourcing, health sciences or related field ( clinical … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within...other vendor performance against project goals and milestones to monitor… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. **Summary** The purpose of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, ... and Figures (TLFs) generated by vendor , ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain… more
- Bristol Myers Squibb (Madison, NJ)
- …Professional (CMPP), and ISMPP active member highly desired + Understanding of clinical trial design and execution, statistical methods and clinical ... related to specified asset(s) in WWMH. **Key Responsibilities** The Senior Manager of Medical Communications is accountable for the following: Medical Communications… more
- AbbVie (Florham Park, NJ)
- …research, scientific presentations and publications for all therapeutic areas, vendor oversight of study executions, RWE methodology research, evidence evaluations ... + Provide statistical expertise for design, analysis and reporting of clinical or scientific research studies or programs and contribute to development… more
- Medtronic (Morristown, NJ)
- …RESPONSIBILITIES:** The following responsibilities are to be performed as appropriate in clinical trial case support and/or case support following commercial ... EKG, blood pressure, wave forms, and ancillary procedural solutions + Knowledge of Clinical trial protocols, and CoreValve and other Medtronic TAVR product IFUs… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …on risk management efforts by identifying and mitigating non-compliance risks across clinical trial vendors and working alongside quality assurance for regular ... on risk management efforts by identifying and mitigating non-compliance risks across clinical trial vendors and working alongside quality assurance for regular… more
- Medtronic (Newark, NJ)
- …EKG, blood pressure, wave forms, and ancillary procedural solutions + Knowledge of Clinical trial protocols, and CoreValve and other Medtronic TAVR product IFUs ... sales leads, and information regarding product price or account activity to District Manager and Clinical or other appropriate company personnel + Ensure a… more
- System One (Basking Ridge, NJ)
- …Salary: $180k - $195K Must Haves: Oncology lead experience. PhD 5+ years Oncology clinical trial experience OR Master in Biostatistics - 8+ years experience. ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more