- Actalent (Princeton, NJ)
- We are seeking a dedicated Senior Clinical Project Manager responsible for overseeing the planning, execution, and management of clinical trials across multiple ... to ensure timely database locks. + Provide regular study updates to senior leadership and stakeholders. + Develop strategies to optimize patient recruitment and… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …in one of our office locations. Fully remote is not eligible._ The ** Senior Clinical Study Lead** (CSL) is expected to operate with high-degree of independence ... clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study… more
- Sanofi Group (Bridgewater, NJ)
- …stretch the limits of what you thought was possible. Ready to get started? The Senior Clinical Research Director (Sr CRD) is noted as the **primary clinical lead for ... deliver to multiple operational tasks. The role of the Senior CRD is to: + Act as a mentor...and/or contribute in the the clinical section of the Investigator 's brochure, CTA, IND, DSUR, INDAR, DRMP, RMP +… more
- Bristol Myers Squibb (Princeton, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . Job Requisition: Senior Principal Scientist, Development DMPK Challenging. Meaningful. Life-changing. ... authorizations across the globe. PCO is looking for a Senior Principal Scientist to join the Dev DMPK group...as DMPK sections for INDs and NDAs / BLAs, Investigator Brochures, briefing books, DSUR, etc. to support clinical… more
- Hackensack Meridian Health (Neptune City, NJ)
- …transform healthcare and serve as a leader of positive change. The ** Senior Clinical Research Coordinator** is responsible for coordinating and overseeing clinical ... out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which the role is assigned. This… more
- Deloitte (Princeton, NJ)
- …case dispositions + Holding meetings with Project Leadership to discuss investigator performance, issue management, and case escalation decisions + Providing ... related software + 4+ Years Experience submitting written and oral reports to senior management and clients + Bachelor's degree in Finance, Business, Law, Criminal… more
- Merck (Trenton, NJ)
- …+ Worldwide marketing applications + Clinical study protocols and reports + Investigator brochures + Local registration study protocols for secondary markets + ... Represent Global Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD) to provide strategic regulatory input and approvals. + Conduct initial content review and approval for IND/CSA submissions to enable clinical trial initiation. +… more
- WuXi AppTec (Cranbury, NJ)
- …review as SOP and protocol required + Function as a Principal Investigator , responsible for pathology-related activities + Conduct planned, long-term education and ... training for junior pathologists + Communicate with sponsors to answer questions and discuss results regarding the pathology report. + Provide consultation to Study Directors on studies. + Ensure the compliance of various GLPs, comply with protocol and SOPs… more
- IQVIA (Parsippany, NJ)
- …are available for filing in the Trial Master File (TMF) and verify that the Investigator 's Site File (ISF) is maintained in accordance with GCP / ICH and local ... regulatory requirements. * Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. * Act as a… more
- Merck (Trenton, NJ)
- …and to improve outcomes for patients. The EDSA leads a large investigator -initiated studies program in partnership with late-stage development teams in Medical ... Congress summary reports. **Primary Responsibilities:** + Leads our Company's Investigator Initiated Studies program in assigned therapeutic areas ensuring… more