- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.Clinical trial protocol development and ... reviews (clinical trial protocols and medical device protocols)ICF reviews to ensure adequate disclosure for collection, retention, testing and retesting of samplesProject Team Participation: Provide device-specific regulatory insight/guidance during CDx… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: Oversees typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares ... guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director, Laboratory Data Management is accountable for the end-to-end delivery ... Accountable for inspection readiness of laboratory data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function with assigned tasks related to steady supply of Clinical Trial Materials (CTM).ResponsibilitiesLead the authoring, revising, and managing the day-to-day ... activities associated with the Dose Preparation Instructions Pharmacy Manual in support of the DSI portfolio. Provide strategic leadership related to HCP focused training materials; Has a focus on strategic and operational excellence; Provide input in Patient… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements & ... variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this position acts as the company liaison… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …successful implementation of the CDx and associated data collection. Oversees clinical trial sample testing activities and data capture to support CDx regulatory ... submission or associated drug regulatory submissions. Contributes to CDx Partner evaluation and selection activities and manages multiple Companion Diagnostics Partnerships to develop, implement and gain regulatory approvals for CDx assays. May function as the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros or tools to ... effectively support all programming needs. Responsibilities include: identify the macros or tools that will facilitate programing efficiency, lead the macro or tool development by working with contractors or by self, and support the macro or tool… more
- Dorsey & Whitney LLP (New York, NY)
- Trial Associate (#952) - New York Dorsey & Whitney LLP is seeking a litigation associate with one to two years of experience to join our New York office. The ... in-court experience and opportunities to work on motion and trial practice. Specifically, this associate will handle the following types of tasks in complex… more
- J&J Family of Companies (Raritan, NJ)
- … Manager actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and Associate , Local Trial ... https://www.jnj.com **Job Function:** R&D Operations **Job Sub** **Function:** Clinical Trial Project Management **Job Category:** Professional **All Job Posting… more
- Mount Sinai Health System (New York, NY)
- … Associate I monitors all aspects of clinical research trial (s) Clinical study life-cycle responsibilities including site management, ongoing maintenance and ... Experience in Phase I-IV clinical studies as a clinical trial assistant or clinical research associate is...a clinical trial assistant or clinical research associate is highly desirable. **Responsibilities** + Prepares and completes… more
- City of New York (New York, NY)
- …day. The Bronx County District Attorney's Office has an opening for a Trial Preparation Assistant to support our Assistant District Attorneys (ADAs) with all aspects ... of investigations and trial preparation in the Special Victims Division. JOB RESPONSIBILITIES:...Exhibit an ability to maintain confidentiality of information COMMUNITY ASSOCIATE - 56057 Qualifications Qualification Requirements 1. High school… more
- City of New York (New York, NY)
- …fair justice. The Bronx County District Attorney's Office currently has openings for Trial Preparation Assistants in the Homicide Bureau and Trial Division to ... filing of documents Timely retrieval of documents and records Assist in preparing hearing/ trial exhibits & discovery for trial Timely conversions of instruments… more
- City of New York (New York, NY)
- …every day. In furtherance of this mission, the BXDA seeks experienced and enthusiastic Trial Preparation Assistants in the Homicide Bureau and Trial Division to ... retrieval of documents and records. - Assist in preparing hearing/ trial exhibits & discovery for trial . -...Trials. - All other relevant duties as assigned. COMMUNITY ASSOCIATE - 56057 Qualifications Qualification Requirements 1. High school… more
- City of New York (New York, NY)
- …fair justice. The Bronx County District Attorney's Office currently has openings for Trial Preparation Assistants in the Homicide Bureau and Trial Division to ... filing of documents Timely retrieval of documents and records Assist in preparing hearing/ trial exhibits & discovery for trial Timely conversions of instruments… more
- City of New York (New York, NY)
- …day. In furtherance of this mission, the BXDA seeks experienced and enthusiastic Trial Preparation Assistant Level 2 (TPA II) to join the Domestic Violence (DV) ... counsel, and legal staff daily. - Notify Officers, EMTS, and medical staff for trial . - Assist with drafting motions to consolidate cases. - Prepare ATF, COCs,… more
- City of New York (New York, NY)
- …Cruelty Prosecution Initiative (ACPI), within the Investigations Division, is seeking Trial Preparation Assistant Level 2 to join ACPI's multidisciplinary team ... retrieval of documents and records - Assist in preparing hearing/ trial exhibits & discovery for trial -...Trials - All other relevant duties as assigned COMMUNITY ASSOCIATE - 56057 Qualifications Qualification Requirements 1. High school… more
- Actalent (Basking Ridge, NJ)
- …address issues, and provide expert-level guidance. The position reports to an Associate Director and involves both strategic planning and operational execution of ... compliance with quality measures and timelines. + Monitor clinical trial performance and quality metrics, escalating issues and proposing...+ 7+ years of experience as a GLOBAL Clinical Trial Manager with a pharmaceutical or biotech company. +… more
- City of New York (New York, NY)
- …supervision, with some latitude for independent judgment and initiative, the Senior Trial Preparation Assistant will be responsible for providing support services to ... (1) Paralegal Aide II to function as a Senior Trial Preparation Assistant for their Adult Protective Services Litigation...Council for Higher Education Accreditation (CHEA); or 2. An associate degree or completion of 60 semester credits from… more
- City of New York (New York, NY)
- …day. In furtherance of this mission, the BXDA seeks experienced and enthusiastic Trial Preparation Assistant Level II in the Appeals Bureau. Specific duties will ... defense requests for exhibits - Retrieving and copying court files and in-house trial folders - Performing all other duties as assigned Preferred Qualifications: -… more
